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United States· US:51316-368_36d83207-9c02-4d9b-aa06-315941b4889a

Sleep Aid

A doxylamin, kombinationen (auch als sedativum) product containing doxylamine succinate, registered in United States by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED. The same ATC class is registered in 12 of our 19 countries.

In shortageATC R06AA59Orange 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…normalisedSleep AidATCR06AA59REGISTER NO.US:51316-368_36d83207…PACKS LISTED1CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about doxylamine succinateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Doxylamin, kombinationen (auch als sedativum) is registered in 12 of 19 countries.

Countries holding a registration under ATC R06AA59 (doxylamin, kombinationen (auch als sedativum)), each read from that country’s own register.

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

Doxylamin, kombinationen (auch als sedativum) · ATC R06AA59

12 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • 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
Doxylamine succinate
Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Country
United States (US)
ATC code
R06AA59
ATC class
Doxylamin, Kombinationen (auch als Sedativum)
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 1

  • ndc11
    5131636822
    3 BLISTER PACK in 1 CARTON (51316-368-22) / 16 TABLET in 1 BLISTER PACK

Regulatory notes

UNII (FDA substance ID)
V9BI9B5YI2
DOXYLAMINE SUCCINATE
RxCUI 23665
Orange Book
A040564
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Doxylamine Succinate and Pyridoxine Hydrochloride Tablet, Delayed Release

Same medicine, other countries

Doxylamin, kombinationen (auch als sedativum) in 9 other countries

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

All doxylamin, kombinationen (auch als sedativum) products

Authorised across Europe · EMA

The same active substance is authorised in 14 EEA countries. Names it is sold under:

  • Austria · Hoggar Night
  • Cyprus · Hoggar Night
  • Germany · Dolginox Schlaftropfen, Doxylamin Dexcel
  • Spain · Dormidina, Dormigen
  • Finland · Dormix
  • France · Donormyl, Doxylamine Arrow Conseil
  • Greece · Hoggar Night
  • Croatia · Hoggar
  • Hungary · Hoggar
  • Malta · Doxylamine Krka, Normodorm
  • Norway · Zonat
  • Poland · Benosen, Doksylamina Geiser
  • Portugal · Dormidina, Hoggar
  • Slovenia · Noctiben Mea

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/df03647e-490a-4400-b77a-cb1393a2f3c6
GET /v1/drugs/df03647e-490a-4400-b77a-cb1393a2f3c6?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": "V9BI9B5YI2",
    "rxcui": "23665",
    "inchikey": "KBAUFVUYFNWQFM-UHFFFAOYSA-N",
    "display_name": "DOXYLAMINE SUCCINATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 5
  },
  "spl_meta": {
    "4b5fdb06-f205-4424-b4cb-dddef921485b": {
      "match": "brand_token",
      "title": "SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [RITE AID CORPORATION]",
      "spl_version": "4",
      "published_date": "2026-05-28"
    }
  },
  "productid": "51316-368_36d83207-9c02-4d9b-aa06-315941b4889a",
  "productndc": "51316-368",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040564",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Aug 27, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DOXYLAMINE SUCCINATE",
  "shortage_reason": "Doxylamine Succinate and Pyridoxine  Hydrochloride Tablet, Delayed Release",
  "shortage_status": "current",
  "proprietary_name": "Sleep Aid",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040564",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxylamine succinate",
  "start_marketing_date": "20250625",
  "active_numerator_strength": "25"
}
API referenceMCP serverPlans

See everything about doxylamin, kombinationen (auch als sedativum).

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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