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United States · US · US:69536-335_41e82253-443b-2119-e063-6394a90a9912

Dimetapp

In shortageUNIISPLATC N02BE

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

Identification

ManufacturerFoundation Consumer Healthcare
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6953633504
    1 BOTTLE in 1 CARTON (69536-335-04) / 118 mL in 1 BOTTLE
  • ndc11
    6953633508
    2 BOTTLE in 1 CARTON (69536-335-08) / 118 mL in 1 BOTTLE

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": {
    "cc09a8c5-d173-4261-b838-96e6a16e2ff9": {
      "match": "brand_token",
      "title": "DIMETAPP COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) ELIXIR [FOUNDATION CONSUMER BRANDS]",
      "spl_version": "5",
      "published_date": "2026-02-25"
    }
  },
  "productid": "69536-335_41e82253-443b-2119-e063-6394a90a9912",
  "productndc": "69536-335",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Dimetapp",
  "active_ingred_unit": "mg/10mL; mg/10mL",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "acetaminophen, diphenhydramine hydrochloride",
  "start_marketing_date": "20240601",
  "active_numerator_strength": "320; 12.5"
}

Related drugs

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