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United States · US · US:0573-2161_ac233de1-41cf-4ef0-a7b4-30f395c88c1a

Advil Allergy and Congestion Relief

Orange BookUNIISPLATC R06AB

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

Identification

ManufacturerHaleon US Holdings LLC
CountryUS (United States)
ATC codeR06AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0573216103
    2 BLISTER PACK in 1 CARTON (0573-2161-03) / 10 TABLET, COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
V1Q0O9OJ9Z
CHLORPHENIRAMINE MALEATE
RxCUI 142429
Orange Book
N022113
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "V1Q0O9OJ9Z",
    "rxcui": "142429",
    "inchikey": "DBAKFASWICGISY-BTJKTKAUSA-N",
    "display_name": "CHLORPHENIRAMINE MALEATE",
    "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": "0573-2161_ac233de1-41cf-4ef0-a7b4-30f395c88c1a",
  "productndc": "0573-2161",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "022113",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4MG;200MG;10MG",
        "product_no": "001",
        "approval_date": "Dec 21, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4MG;200MG;10MG",
        "product_no": "002",
        "approval_date": "Apr 28, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE",
  "proprietary_name": "Advil Allergy and Congestion Relief",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA022113",
  "marketing_category": "NDA",
  "nonproprietary_name": "chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride",
  "start_marketing_date": "20120723",
  "active_numerator_strength": "4; 200; 10"
}

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