Dextromethorphan

Federal result only, preserving the packet scope. The current eCFR Part 1308 text is the inspected federal schedule index and contains no dextromethorphan or dextromethorphan hydrobromide entry; its Schedule IV section instead identifies the separate tramadol chemical entry. DailyMed independently labels a dextromethorphan hydrobromide product HUMAN OTC DRUG LABEL with DEA Schedule: None and OTC Monograph Drug M012. The FDA monograph supports nonprescription status only for qualifying antitussive formulations meeting its ingredient, dosage-form, dosage, labeling, and other requirements; it does not establish that every DXM formulation or product is OTC. No state controlled-substance, age, purchase, retail, or formulation rule was researched or changed. The federal analogue statutes are fact-specific: the sources do not make a separate analogue determination for DXM, and DXM's non-scheduled status must not be read as a blanket conclusion about an unrelated or novel substance that might be litigated under 21 U.S.C. §§ 802(32) and 813.

The selected legacy row is directionally correct but understates the rule: this is not a matter of some pharmacies choosing to require prescriptions. SÚKL's dextromethorphan-specific notice identifies Stopex 30 mg tablets and MedDex Vicks honey lozenges as changed from non-prescription to prescription-only effective 15 August 2017. SÚKL's 2021 professional guidance describes the broader formulation distinction (monocomponent solid forms prescription-only; monocomponent liquid and polycomponent medicines without prescription). However, the current SÚKL FAQ makes clear that dispensing information is product-level in the current medicines database, and the dossier's live-source limitation means the 2021 generic statement should not be treated as a current classification for every unqueried presentation. Exact current status must be checked by product, strength, route and pack. The current e-Sbírka schedule expressly exempts stereoisomeric dextromethorphan from the levomethorphan narcotic entry; this does not make every preparation unrestricted, because the medicines regime still applies.

Stage A did not establish the existing blanket claim that DXM-only and DXM combination products are available over the counter without prescription. Stage B establishes the narrower current classification stated by the Iranian FDA: products containing dextromethorphan are under special oversight for distribution, supply and consumption. This corrects the selected row without expanding its scope. The notice does not state a universal prescription-only rule, an OTC rule, or a controlled-substance schedule for every DXM product; product- and formulation-specific dispensing requirements therefore remain unestablished.

The legacy Italy row is supported for the controlled-substance question: the operative 2007 decree expressly excludes Destrometorfano from Table I, and the current Normattiva record and latest 2026 table amendment were inspected for recency. Stage B adds the important product-level qualification: current AIFA determinations for two dextromethorphan-hydrobromide medicines classify the cited packages as SOP, not OTC (both are non-prescription). The AIFA November 2024 CSE advisory was also inspected, but its provisional entry for procedure N1B/2024/1065 was not used as the final product classification because the subsequent published AIFA determination for Bechilar gives the operative SOP classification. Unscheduled describes the ingredient's narcotic/psychotropic table status; it does not mean that every formulation is unregulated or has identical pharmacy supply conditions.

Corrected from the uncited 'Prohibited/Restricted' row. Stage A current schedule and amendment review found no exact dextromethorphan/dekstrometorfāns entry, although the annex lists the distinct substances levometorfāns and racemetorfāns and the controlled-substances law contains generic derivative/isomer language. That omission is not treated as a blanket unrestricted finding because the statute's broad scope clause may require interpretation for a stereoisomer-related substance. Stage B current ZVA records establish real lawful medicines with both OTC and prescription classifications, so no blanket prohibition or single substance-wide prescription status is asserted. Classification is product-, dose-, form- and package-dependent under Cabinet Regulation No. 885. The prescription regulation used for the legal framework is displayed as expiring on 2026-09-01; this result is limited to the 2026-08-27 access date and does not assert post-expiry prescription mechanics.

Supported repair of the selected row using the dossier's current 2026 product evidence. Stage A: the current LGS is expressly marked text vigente with reforms through 15 January 2026; exact-name searches found no dextrometorfano, dextromethorphan or bromhidrato de dextrometorfano entry, but Article 234 expressly lists levometorfan and racemetorfan and covers listed-estupefaciente isomers unless excepted. Articles 246 and 255 also preserve determination-based controls for otherwise unlisted substances or medicines. Stage B: COFEPRIS's official alopathic-registration PDF updated 4 August 2026 marks SALNADRIL (007M2026) and DEFENEXTRIL (028M2026) as Article 226 VI with future validity dates, supporting the original no-prescription/outside-pharmacy statement for those current presentations. The statement is narrowed to identified products and does not assert that every dextromethorphan strength, combination, importer, future registration or non-medicinal material has the same status. No recreational-use, possession, analogue or blanket all-formulations claim is made.

The DDB list expressly says that dextromethorphan and dextrorphan are not under international control. It separately reproduces the Philippine Schedule and, on inspection of that named enumeration, contains no exact dextromethorphan row. The related entries levomethorphan, racemethorphan and racemorphan must not be treated as dextromethorphan: the DDB preamble extends isomer/ester/ether/salt coverage to drugs listed in that schedule, not to an unlisted neighboring substance. The FDA Annex A entry is active-ingredient level: it gives Dextromethorphan the PH classification but does not separately enumerate hydrobromide/free-base salts, combinations, strengths, dosage forms, routes or pack sizes. Therefore the result supports the active ingredient's pharmacist-only non-prescription classification, while product-specific registration and formulation conditions remain a caveat. The DDB PDF is dated July 2025 and was the latest official consolidated schedule located on 27 August 2026; no later DDB consolidated schedule was identified. FDA source check product pages were not used because the public endpoint returned HTTP 403; no brand-specific CPR claim is made.

The latest inspected schedule amendment is Lei n.º 19-F/2026: it republishes Table I-A and entered into force on 2026-05-09. The republished Table I-A retains both the structural notes and the express dextromethorphan/dextrorphan exclusion. The structural notes generally include chemically specifically designable isomers unless expressly excluded, esters and ethers unless in another table, and possible salts including salts of those esters, ethers and isomers. The named dextromethorphan exclusion must not be expanded into an unsupported blanket conclusion about every derivative, salt, strength, dosage form or preparation. Article 15 of Decree-Law 15/93 imposes special prescription for Tables I-II and ordinary-law prescription for Tables III-IV; those table controls do not attach merely because the expressly excluded dextromethorphan name appears. Under Estatuto do Medicamento, authorization classifies each medicine as MSRM or MNSRM; MSRM criteria and special-prescription criteria remain applicable to the exact authorized product. The official INFARMED MNSRM endpoint (titled medicines not subject to prescription and not reimbursed by the SNS) returned 29 matching dextrometorfano rows on 2026-08-27, including oral solutions, syrups and a soft lozenge at different strengths and pack sizes. This supports the row's MNSRM product statement for the listed presentations, not an across-the-board classification for unlisted products.

The controlled-substance result is supported: the official Roszdravnadzor consolidated Resolution 681 page/PDF (fetched 2026-08-27) identifies the supplied copy as redacted 11 June 2025 and expressly places Декстрометорфан in List III. List III means restricted circulation with possible exclusion of some controls, and 3-FZ Article 2(5) provides the statutory small-quantity-preparation route. The schedule's notes address trade names, synonyms, preparations and derivatives; 3-FZ separately supplies the analogue and NPS rules. This should replace any blanket 'illegal' or blanket 'OTC' statement. Exact current registration and prescription/OTC status of every dextromethorphan-containing medicine was not established: the current EGISZ/RLP test portal could not be fetched because of certificate failure, while the Ministry's accessible open-data registry page is explicitly only updated through 29 January 2017. Product-level status must therefore be checked in the current state medicines register and approved instruction for the exact strength/formulation. The official publication portal timed out; do not infer that no later amendments exist from that failure. The official Roszdravnadzor archive labels its Resolution 964 index an archive as of 30 December 2020, and the separately fetched official 10 April 2023 Resolution 581 page/PDF confirms a later amendment to Resolution 964; neither source changes the supported List III finding for dextromethorphan.

The readable official consolidated schedules place the exact entry ‘Dextromethorphan.’ in Schedule 2, with no parenthetical dosage, strength, route, or formulation exception printed on that line. The Schedule 2 preamble extends this listing to preparations and mixtures containing or purporting to contain it, including salts and esters where their existence is possible, unless expressly excluded; product-specific registration, formulation, strength, route, indication, pack-size, and licensing conditions remain separate questions. Section 22A(5)(a) limits non-prescription Schedule 2 sale to a pharmacist, pharmacist intern, or supervised pharmacist’s assistant, and section 22A(6)(a) requires prescribed sale particulars to be recorded in a prescription book or other permanent record; section 22A(6)(e) requires prescription/order safeguards for supply to a person apparently under 12. SAHPRA’s current portal records a consolidated-schedules version updated 06 July 2026, and the official Government Gazette 54627 attachment dated 08 May 2026 was inspected. The current consolidated PDF is hosted behind a SharePoint download that returned HTTP 403 to the reader, while the 2026 Gazette attachment is scanned image-only; the exact substance text is therefore quoted from SAHPRA’s readable 01 August 2025 consolidation, which SAHPRA labels archived and ‘DO NOT USE’. The later SAHPRA/Gazette records establish the currentness chain but do not support a claim that every 2026 schedule entry is unchanged. This supports the existing Legal (Regulated) classification at the substance/Schedule 2 level, not an assertion that every dextromethorphan product is freely retail-available.

Current LVFS 2011:10 expressly lists Dextrometorfan (DXM) in Swedish list V. Its exact exception is limited to preparations for medical or scientific use in solution containing no more than 3 mg/ml; this is a formulation/concentration exception from this narcotics-list entry, not a blanket OTC determination for all DXM. Outside the exception, the Narcotic Drugs Control Act limits importing, exporting, manufacturing, offering for sale, transferring and possessing narcotics to specified authorized purposes and persons, and the Narcotic Drugs Penal Law criminalizes unauthorized possession, use and other handling (basic maximum three years). Dexfarm 20 mg tablet is a current official product example marked prescription-only (Receptbelagt), demonstrating that medicine status is product/package-specific. The packet's 1 September 2008 date is confirmed by the official initial amendment SFS 2008:728, which entered into force on 1 September 2008. Current HSLF-FS 2026:26 was published 2026-07-02 and entered into force 2026-07-14; the current consolidated LVFS expressly incorporates it. No claim is made that every DXM product has Dexfarm's prescription classification.

Stage A (controlled-substance status): the current AFMPS legislation page identifies the 6 September 2017 Royal Decree as the governing framework and states that the consolidated annex aids are not themselves legally authoritative; the current Annex I aid, updated for the 29 March 2026 position and corrected 16 July 2026, expressly excludes Dextromethorphan and Dextrorphan from the surrounding generic morphinan/morphine entry. Annexes II, III, IV (including its named Annex IVB list and generic groups) and V were also inspected for the exact name and generic coverage, with no Dextromethorphan entry or matching morphinan generic group found. Stage B (medicines and dispensing): the dossier's latest approved inspected product, Dextromethorphan Winadol (approved 04/2026), is Délivrance libre but its leaflet limits use to over-12s and warns about abuse/dependence. The Medicines Act generic definition and 2006 classification decree confirm that generic identity and prescription category are distinct, and that packaging-specific derogations are permitted. Independent AFMPS product leaflets establish that Bronchosedal and Toularynx small packs are also free supply but limit use to age 6 and over; Dextroforme bulk supply is prescription-only from 360 ml and is not delivered as such to the public. This corrects the selected row's unsupported blanket claim of OTC availability 'without age restriction' while preserving its country scope; it does not assert that every possible dextromethorphan preparation has the same dispensing category.

Supported and updated from the legacy Legal (Regulated) row. The June 2026 INVIMA OTC list directly supports venta libre for the exact dextromethorphan hydrobromide concentrations, forms and combinations it enumerates. Resolution 1403 defines OTC supply as acquisition without prescriber intervention. Resolution 0116, effective from 27 January 2026, was read through its complete current schedule pagination: dextromethorphan/dextromethorphan hydrobromide is not expressly named in Annex Technical 1 or human Annex Technical 3, and the similarly named D entries are distinct substances. This is a direct-list result, not a claim that every conceivable dextromethorphan product is OTC or that a product containing another controlled active ingredient is exempt. A qualifying product must match the INVIMA-listed formulation and hold the required sanitary registration; unregistered or otherwise non-compliant manufacture and marketing remain subject to sanitary measures and administrative sanctions under Decreto 677. Article 376 criminal penalties concern the scheduled substances within its text and do not make ordinary listed OTC dextromethorphan supply narcotics trafficking on the inspected record.

Supported normalization of the legacy 'Prescription Type A' entry. The current product record directly places Dexofan 30 mg dextromethorphan tablets in dispensing group A, and the current prescription regulation defines group A as a prescription dispensing group with the stated one-time dispensing rule. Dextromethorphan is separately named List C no. 3 in the operative 2026 euphoriants regulation, but List C's explanatory text and § 1(3)(3) exclude ordinary dosed pharmaceutical preparations containing no more than 0.1 g per unit. Dexofan contains 30 mg (0.03 g) per tablet, below that threshold; therefore the product-specific result is prescription_only rather than prohibited. The 2026 regulation's effective date and repeal of the prior 2021 instrument were checked.

Repaired to the supported scope only: the current Malaysian Ministry of Health schedule expressly lists dextromethorphan and its salts, and the Poisons Act limits Part I retail and supply to specified regulated channels. Section 19 limits professional supply or administration of a non-Group-A poison to medical, dental, or animal treatment. The inspected sources do not state a standalone blanket offence phrased as recreational use of dextromethorphan being prohibited, so that claim is removed. The extracted schedule does not reliably preserve the Group A/B/C/D column alignment; no specific group designation or prescription classification is asserted.

Supported repair after refutation of the earlier 'Controlled (Analog Act)' wording. Norway has no cited Analog Act here. The current Narkotikaforskriften (last amended effective 1 June 2026) expressly covers psychoactive stereoisomers of substances listed in Narkotikalisten, and the current table lists Levometorfan (N I) and Racemetorfan (metorfan) (N I), not dextromethorphan by exact name. Accordingly, this entry uses the stereoisomer route only: dextromethorphan's coverage is conditional on verified identity as the psychoactive dextrorotatory stereoisomer of levomethorphan. The conclusion is not an analogue or generic-analogue claim. If that condition is met, Legemiddelloven § 24 prohibits possession/use without lawful access and § 31 sets the stated up-to-six-month penalty; lawful-access and other statutory exceptions remain outside the blanket description.

The prior Class A Prescription Drug statement is not supported and is corrected. S 681/2023 deleted Dextromethorphan from Part 1 of the HPA Second Schedule and inserted it in Part 3; the current HPA schedule identifies Part 3 as active ingredients in pharmacy-only medicines. HSA defines POM as supply only by a doctor or pharmacist according to a doctor's prescription, but defines P as supply by or under pharmacist supervision. The current NDF identifies both DURO-TUSS DM DRY COUGH LIQUID 15MG/5ML (SIN17494P) and NOSPAN TABLET 30 MG (SIN10341P), each containing dextromethorphan, as PHARMACY ONLY MEDICINES. The Poisons Rules entry and 1.5% exception are retained as a non-therapeutic/legacy-scope caveat, not used to reclassify HPA therapeutic products as Class A prescription medicines.

The existing prescription-only characterization is supported at product level: the fetched official Antalya provincial Ministry of Health list places METORFAN 20 DRAJE alongside the active ingredient DEKSTROMETORFAN HBR under the heading for medicines that must be supplied by normal prescription and are subject to monitoring. The same list also contains combination products (for example BENICAL, BRONKAR-A, DORFAN and GUDEF), so the evidence must not be generalized to every dextromethorphan strength, formulation, pack or combination. TİTCK Generalge 2018/1 explains that monitored normal-prescription medicines are prescribed through the Renkli Reçete Sistemi and dispensed after pharmacy recording; this does not convert them into red- or green-prescription medicines. The current consolidated 2313/TCK schedule endpoints could not be inspected because the official mevzuat.gov.tr endpoints failed certificate source check, and no current national product-level schedule was exposed by the official Ministry index pages inspected. Law No. 7445 Article 17's quoted aggravated derivative classes do not name dextromethorphan; that omission is not treated as proof that DXM is unscheduled. A current national schedule and exact product authorization should be checked before making a substance-wide or criminal-schedule conclusion.