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United States · US · US:51316-803_9d0ed71c-c1ac-498d-8174-98c687cc5696

Pain, Headache and Cough

In shortageUNIISPLATC N02BE

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5131680309
    2 BLISTER PACK in 1 CARTON (51316-803-09) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Acetaminophen; Oxycodone Hydrochloride Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "362O9ITL9D",
    "rxcui": "161",
    "inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
    "display_name": "ACETAMINOPHEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "41a77cbb-6a4d-46a4-ab27-c7affa2cc682": {
      "match": "brand_token",
      "title": "PAIN, HEADACHE AND CONGESTION (ACETAMINOPHEN, GUAIFENESIN) TABLET, FILM COATED [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]",
      "spl_version": "4",
      "published_date": "2026-05-20"
    }
  },
  "productid": "51316-803_9d0ed71c-c1ac-498d-8174-98c687cc5696",
  "productndc": "51316-803",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Pain, Headache and Cough",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Acetaminophen, Dextromethorphan HBr",
  "start_marketing_date": "20260421",
  "active_numerator_strength": "325; 10"
}

Related drugs

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