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United States · US · US:50332-0141_866ea7b4-cf9b-4001-a533-12b8f562e042

CETAFEN COUGH and COLD

In shortageUNIISPLATC N02BE

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

Identification

ManufacturerHART Health
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5033201413
    20 PACKET in 1 BAG (50332-0141-3) / 2 TABLET, FILM COATED in 1 PACKET
  • ndc11
    5033201414
    40 PACKET in 1 BOX (50332-0141-4) / 2 TABLET, FILM COATED in 1 PACKET
  • ndc11
    5033201417
    100 PACKET in 1 BOX (50332-0141-7) / 2 TABLET, FILM COATED in 1 PACKET

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": {
    "44da0d8c-4a12-4122-99da-781e2809e1a8": {
      "match": "brand_token",
      "title": "CETAFEN COUGH AND COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,) TABLET, FILM COATED [HART HEALTH]",
      "spl_version": "4",
      "published_date": "2025-12-25"
    }
  },
  "productid": "50332-0141_866ea7b4-cf9b-4001-a533-12b8f562e042",
  "productndc": "50332-0141",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "CETAFEN COUGH and COLD",
  "active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "M",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl , Guaifenesin, ,",
  "start_marketing_date": "20230109",
  "active_numerator_strength": "325; 10; 100; 5"
}

Related drugs

Other records sharing ATC code N02BE.

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