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United States · US · US:0573-0134_40429ef4-846a-eb4c-e063-6394a90ab7a9

Advil

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerHaleon US Holdings LLC
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0573013420
    1 BOTTLE in 1 CARTON (0573-0134-20) / 20 TABLET, COATED in 1 BOTTLE
  • ndc11
    0573013480
    1 BOTTLE in 1 CARTON (0573-0134-80) / 80 TABLET, COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
RM1CE97Z4N
IBUPROFEN SODIUM
Orange Book
N201803
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "RM1CE97Z4N",
    "rxcui": null,
    "inchikey": "VTGPMVCGAVZLQI-UHFFFAOYSA-M",
    "display_name": "IBUPROFEN SODIUM",
    "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": "0573-0134_40429ef4-846a-eb4c-e063-6394a90ab7a9",
  "productndc": "0573-0134",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "201803",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 200MG BASE",
        "product_no": "001",
        "approval_date": "Jun 12, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN SODIUM",
  "proprietary_name": "Advil",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA201803",
  "marketing_category": "NDA",
  "nonproprietary_name": "ibuprofen sodium",
  "start_marketing_date": "20130708",
  "active_numerator_strength": "256"
}

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