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United States · US · US:53345-045_27c7a311-d24c-3a6e-e063-6394a90a5902

Cough and Cold plus

In shortageUNIISPLATC N02BE

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

Identification

ManufacturerHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5334504501
    1 BAG in 1 BOX (53345-045-01) / 4000 CAPSULE, LIQUID FILLED in 1 BAG

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": {
    "ff39084f-ab2f-48ed-ac62-837f7fff2b65": {
      "match": "brand_token",
      "title": "COUGH AND COLD HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]",
      "spl_version": "11",
      "published_date": "2026-06-01"
    }
  },
  "productid": "53345-045_27c7a311-d24c-3a6e-e063-6394a90a5902",
  "productndc": "53345-045",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Cough and Cold plus",
  "active_ingred_unit": "mg/1; mg/1; mg/1; mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Acetaminophen, Phenylephrine HCl, Chlorpheniramine Maleate, Dextromethorphan HBr",
  "start_marketing_date": "20170324",
  "active_numerator_strength": "325; 2; 10; 5"
}

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