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United States · US · US:0573-0180_cec76100-19bc-49c3-8805-7badb2a8bf28

ADVIL COLD AND SINUS

Orange BookUNIISPLATC C01EB

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

Identification

ManufacturerHaleon US Holdings LLC
CountryUS (United States)
ATC codeC01EB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0573018010
    2 BLISTER PACK in 1 CARTON (0573-0180-10) / 10 TABLET, COATED in 1 BLISTER PACK
  • ndc11
    0573018021
    4 BLISTER PACK in 1 CARTON (0573-0180-21) / 10 TABLET, COATED in 1 BLISTER PACK
  • ndc11
    0573018080
    2 CARTON in 1 PACKAGE (0573-0180-80) / 4 BLISTER PACK in 1 CARTON / 10 TABLET, COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
N019771
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "WK2XYI10QM",
    "rxcui": "5640",
    "inchikey": "HEFNNWSXXWATRW-UHFFFAOYSA-N",
    "display_name": "IBUPROFEN",
    "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": "0573-0180_cec76100-19bc-49c3-8805-7badb2a8bf28",
  "productndc": "0573-0180",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "019771",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "200MG;30MG",
        "product_no": "001",
        "approval_date": "Sep 19, 1989"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "ADVIL COLD AND SINUS",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA019771",
  "marketing_category": "NDA",
  "nonproprietary_name": "ibuprofen and pseudoephedrine hydrochloride",
  "start_marketing_date": "19890919",
  "active_numerator_strength": "200; 30"
}

Related drugs

Other records sharing ATC code C01EB.

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