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United States · US · US:0573-0170_88972802-d04c-4fe3-8c56-3c3d1e3b4218

CHILDRENS 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 · 3

  • ndc11
    0573017001
    1 BOTTLE in 1 CARTON (0573-0170-01) / 30 mL in 1 BOTTLE
  • ndc11
    0573017030
    1 BOTTLE in 1 CARTON (0573-0170-30) / 120 mL in 1 BOTTLE
  • ndc11
    0573017032
    1 BOTTLE in 1 CARTON (0573-0170-32) / 120 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
N020589
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": {
    "436c0126-4ff3-c082-e063-6294a90a3d72": {
      "match": "brand_token",
      "title": "CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [KESIN PHARMA CORPORATION]",
      "spl_version": "2",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0573-0170_88972802-d04c-4fe3-8c56-3c3d1e3b4218",
  "productndc": "0573-0170",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "020589",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG/5ML",
        "product_no": "001",
        "approval_date": "Jun 27, 1996"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG/5ML",
        "product_no": "002",
        "approval_date": "Nov 7, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "CHILDRENS ADVIL",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA020589",
  "marketing_category": "NDA",
  "nonproprietary_name": "ibuprofen",
  "start_marketing_date": "19960627",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code G02CC01.

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