INFANTS ADVIL

Orange BookUNIISPLATC G02CC01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerHaleon US Holdings LLC

CountryUS (United States)

ATC codeG02CC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
0573019120
1 BOTTLE, DROPPER in 1 CARTON (0573-0191-20) / 15 mL in 1 BOTTLE, DROPPER
ndc11
0573019122
1 BOTTLE, DROPPER in 1 CARTON (0573-0191-22) / 15 mL in 1 BOTTLE, DROPPER
ndc11
0573019150
1 BOTTLE, DROPPER in 1 CARTON (0573-0191-50) / 30 mL in 1 BOTTLE, DROPPER
ndc11
0573019175
1 BOTTLE, DROPPER in 1 CARTON (0573-0191-75) / 22.5 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)

WK2XYI10QM

IBUPROFEN

RxCUI 5640

Orange Book

N020812

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": {
    "6509a545-0036-460a-8f0d-b31caae17855": {
      "match": "brand_token",
      "title": "INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [AUROHEALTH LLC]",
      "spl_version": "2",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0573-0191_9f156faa-6bf8-483c-837d-050e40ec0cc5",
  "productndc": "0573-0191",
  "dosage_form": "SUSPENSION/ DROPS",
  "orange_book": {
    "appl_no": "020812",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "100MG/2.5ML",
        "product_no": "001",
        "approval_date": "Jan 30, 1998"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "50MG/1.25ML",
        "product_no": "002",
        "approval_date": "Jan 12, 2000"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "INFANTS ADVIL",
  "active_ingred_unit": "mg/1.25mL",
  "application_number": "NDA020812",
  "marketing_category": "NDA",
  "nonproprietary_name": "ibuprofen",
  "start_marketing_date": "19980130",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code G02CC01.

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