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United States · US · US:58602-003_317fdce4-a082-4e9a-85b8-380ab68a6631

CHILDRENS IBUPROFEN

Orange BookUNIISPLATC G02CC01

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

Identification

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

Packs · 2

  • ndc11
    5860200320
    1 BOTTLE in 1 CARTON (58602-003-20) / 240 mL in 1 BOTTLE
  • ndc11
    5860200324
    1 BOTTLE in 1 CARTON (58602-003-24) / 120 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A209179
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": "58602-003_317fdce4-a082-4e9a-85b8-380ab68a6631",
  "productndc": "58602-003",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "209179",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG/5ML",
        "product_no": "001",
        "approval_date": "Apr 17, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "CHILDRENS IBUPROFEN",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA209179",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20210616",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code G02CC01.

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