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United States · US · US:58602-227_2a48af51-23e2-4fec-a76b-eef1611750f5
Infants 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
- ndc1158602227041 BOTTLE in 1 CARTON (58602-227-04) / 15 mL in 1 BOTTLE
- ndc1158602227071 BOTTLE in 1 CARTON (58602-227-07) / 30 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A213506
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": "58602-227_2a48af51-23e2-4fec-a76b-eef1611750f5",
"productndc": "58602-227",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "213506",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "40MG/ML",
"product_no": "001",
"approval_date": "Apr 8, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Infants Ibuprofen",
"active_ingred_unit": "mg/1.25mL",
"application_number": "ANDA213506",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20240408",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code G02CC01.
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