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United States · US · US:0573-0145_9c2623fc-aba0-4ae6-bb1e-e1e52f47b09c

ADVIL DUAL ACTION WITH ACETAMINOPHEN

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerHaleon US Holdings LLC
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    0573014502
    2 TABLET, FILM COATED in 1 POUCH (0573-0145-02)
  • ndc11
    0573014518
    1 BOTTLE in 1 CARTON (0573-0145-18) / 18 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0573014572
    1 BOTTLE in 1 CARTON (0573-0145-72) / 72 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0573014589
    1 BOTTLE in 1 CARTON (0573-0145-89) / 144 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0573014599
    3000 POUCH in 1 CASE (0573-0145-99) / 2 TABLET, FILM COATED in 1 POUCH

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
N211733
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": {
    "a3c30dd2-75f3-4f8b-88d7-4a63dea5bad7": {
      "match": "brand_token",
      "title": "ADVIL PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [NAVAJO MANUFACTURING COMPANY INC.]",
      "spl_version": "3",
      "published_date": "2026-04-09"
    }
  },
  "productid": "0573-0145_9c2623fc-aba0-4ae6-bb1e-e1e52f47b09c",
  "productndc": "0573-0145",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "211733",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "250MG;125MG",
        "product_no": "001",
        "approval_date": "Feb 28, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; IBUPROFEN",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "ADVIL DUAL ACTION WITH ACETAMINOPHEN",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA211733",
  "marketing_category": "NDA",
  "nonproprietary_name": "Ibuprofen, Acetaminophen",
  "start_marketing_date": "20230116",
  "active_numerator_strength": "250; 125"
}

Related drugs

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