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United States · US · US:50580-100_2bcd0083-0ce4-1d04-e063-6294a90a8b97

Infants Motrin

Orange BookUNIISPLATC G02CC01

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

Identification

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

Packs · 1

  • ndc11
    5058010018
    1 BOTTLE in 1 CARTON (50580-100-18) / 15 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
N020603
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": "50580-100_2bcd0083-0ce4-1d04-e063-6294a90a8b97",
  "productndc": "50580-100",
  "dosage_form": "SUSPENSION/ DROPS",
  "orange_book": {
    "appl_no": "020603",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "40MG/ML",
        "product_no": "001",
        "approval_date": "Jun 10, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Infants Motrin",
  "active_ingred_unit": "mg/1.25mL",
  "application_number": "NDA020603",
  "marketing_category": "NDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20040601",
  "active_numerator_strength": "50"
}

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