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United States · US · US:49483-430_3a6f8b16-c8a2-7195-e063-6394a90ac5fd

Extra strength Acetaminophen PM

In shortageUNIISPLATC N02BE

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

Identification

ManufacturerTIME CAP LABS INC
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4948343040
    400 TABLET in 1 BOTTLE (49483-430-40)

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": {
    "525467fb-510d-0b4b-e063-6294a90acd36": {
      "match": "brand_token",
      "title": "EXTRA STRENGTH TYLENOL COLD PLUS FLU MULTI-SYMPTOM NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [KENVUE BRANDS LLC]",
      "spl_version": "1",
      "published_date": "2026-06-02"
    }
  },
  "productid": "49483-430_3a6f8b16-c8a2-7195-e063-6394a90ac5fd",
  "productndc": "49483-430",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Extra strength Acetaminophen PM",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "M013",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Acetaminophen 500mg/ Diphenhydramine HCl 25mg",
  "start_marketing_date": "20230722",
  "active_numerator_strength": "500; 25"
}

Related drugs

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