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United States· US:51316-263_fcfcff9e-c6b4-4d99-9c1e-e05349cf2eed

12 HR RELIEF COUGH DM

A dextromethorphan, kombinationen product containing dextromethorphan polistirex, registered in United States by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED. The same ATC class is registered in 4 of our 19 countries.

ATC N07XX59Orange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalised12 HR RELIEF COUGH DMATCN07XX59REGISTER NO.US:51316-263_fcfcff9e…PACKS LISTED1CHECKEDJune 3, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about dextromethorphan polistirexAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Dextromethorphan, kombinationen is registered in 4 of 19 countries.

Countries holding a registration under ATC N07XX59 (dextromethorphan, kombinationen), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 4 of them publish a price we can compare per daily dose
Search dextromethorphan, kombinationen products by name

Dextromethorphan, kombinationen · ATC N07XX59

4 / 19 countries

  • Belgiumprice
  • Finlandprice
  • Norwayprice
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
dextromethorphan polistirex
Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Country
United States (US)
ATC code
N07XX59
ATC class
Dextromethorphan, Kombinationen
Defined daily dose
40 mg, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    5131626321
    1 BOTTLE in 1 CARTON (51316-263-21) / 89 mL in 1 BOTTLE

Regulatory notes

UNII (FDA substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
Orange Book
A091135
DailyMed SPL labels
1 version tracked

Same medicine, other countries

Dextromethorphan, kombinationen in 15 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All dextromethorphan, kombinationen products

Authorised across Europe · EMA

The same active substance is authorised in 24 EEA countries. Names it is sold under:

  • Austria · Easybronchial Stop Forte, Easybronchial Stop Junior
  • Belgium · Acatar Mono, Bisolvon Droge Hoest
  • Bulgaria · Демефан, Динарекс
  • Cyprus · Diacol, Medorphan
  • Czechia · Dextromethorphan Nutra Essential, Robitussin Antitussicum Na Suchý Dráždivý Kašel
  • Germany · Dextro, Hustenstiller
  • Denmark · Dexofan
  • Estonia · Dinarex
  • Spain · Bicasan, Bisolvon Antitusivo
  • Finland · Resilar, Rometor
  • France · Biocadextro Adultes Sans Sucre, Dextromethorphane Sans Sucre, Édulcorée Au Maltitol Liquide Et À La Saccharine Sodique Biogaran
  • United Kingdom (Northern Ireland) · Asda Strong Dry Tickly Cough, Bell's Healthcare Dual Action Dry Cough
  • Hungary · Meddex Méz Ízű, Rhinathiol Köhögéscsillapító Felnőtteknek
  • Ireland · Benylin Non-Drowsy Dry Coughs, Robitussin Dry Cough
  • Iceland · Dexól, Dinarex
  • Italy · Aricodiltosse, Bechilar
  • Luxembourg · Acatar Mono, Bisolvon Toux Sèche
  • Latvia · Dinarex
  • Malta · Benylin Non-Drowsy Dry Coughs, Diacol
  • Netherlands · Daro Retard, Tussipect
  • Poland · Acodin, Inovox Na Kaszel Smak Miodowo-Cytrynowy
  • Portugal · Benflux Tosse Seca, Bisoltussin
  • Romania · Robitussin Antitussicum Pentru Tuse Uscată, Robitussin Junior Pentru Tuse Uscată
  • Slovakia · Dextromethorphan Nutra Essential, Dinarex

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/a988039f-a0c7-4962-a456-47134f69fd6d
GET /v1/drugs/a988039f-a0c7-4962-a456-47134f69fd6d?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "unii": {
    "unii": "9D2RTI9KYH",
    "rxcui": "102490",
    "inchikey": "STTADZBLEUMJRG-IKNOHUQMSA-N",
    "display_name": "DEXTROMETHORPHAN HYDROBROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d63fff6c-a1cd-4636-b1d3-ae83be40c3f7": {
      "match": "brand_token",
      "title": "12 HR RELIEF COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]",
      "spl_version": "2",
      "published_date": "2026-04-24"
    }
  },
  "productid": "51316-263_fcfcff9e-c6b4-4d99-9c1e-e05349cf2eed",
  "productndc": "51316-263",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "091135",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 30MG HYDROBROMIDE/5ML",
        "product_no": "001",
        "approval_date": "May 25, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE",
  "proprietary_name": "12 HR RELIEF COUGH DM",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA091135",
  "marketing_category": "ANDA",
  "nonproprietary_name": "dextromethorphan polistirex",
  "start_marketing_date": "20260414",
  "active_numerator_strength": "30"
}
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This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

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