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United States · US · US:51316-809_1d247756-17b5-4a31-83ad-40c0700cd1c7

Pain, Headache and Congestion

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
    5131680909
    2 BLISTER PACK in 1 CARTON (51316-809-09) / 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": "51316-809_1d247756-17b5-4a31-83ad-40c0700cd1c7",
  "productndc": "51316-809",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; GUAIFENESIN",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Pain, Headache and Congestion",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Acetaminophen, Guaifenesin",
  "start_marketing_date": "20260429",
  "active_numerator_strength": "325; 200"
}

Related drugs

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