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United States · US · US:0573-0199_3a894971-32f7-0c16-e063-6294a90aa8d9

ADVIL SINUS CONGESTION AND PAIN

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 · 5

  • ndc11
    0573019901
    50 POUCH in 1 TRAY (0573-0199-01) / 1 TABLET, COATED in 1 POUCH
  • ndc11
    0573019903
    3000 POUCH in 1 CARTON (0573-0199-03) / 1 TABLET, COATED in 1 POUCH
  • ndc11
    0573019911
    10 BLISTER PACK in 1 CARTON (0573-0199-11) / 1 TABLET, COATED in 1 BLISTER PACK
  • ndc11
    0573019921
    20 BLISTER PACK in 1 CARTON (0573-0199-21) / 1 TABLET, COATED in 1 BLISTER PACK
  • ndc11
    0573019922
    30 BLISTER PACK in 1 CARTON (0573-0199-22) / 1 TABLET, COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
N022565
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": "0573-0199_3a894971-32f7-0c16-e063-6294a90aa8d9",
  "productndc": "0573-0199",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "022565",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "200MG;10MG",
        "product_no": "001",
        "approval_date": "May 27, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE",
  "proprietary_name": "ADVIL SINUS CONGESTION AND PAIN",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA022565",
  "marketing_category": "NDA",
  "nonproprietary_name": "ibuprofen, phenylephrine hydrochloride",
  "start_marketing_date": "20150701",
  "active_numerator_strength": "200; 10"
}

Related drugs

Other records sharing ATC code C01EB.

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