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United States · US · US:53041-634_510c1692-f23a-497b-8738-4b29e7c549e8
Childrens Ibuprofen
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGuardian Drug Company
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1153041634031 BOTTLE in 1 CARTON (53041-634-03) / 120 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A210149
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": "53041-634_510c1692-f23a-497b-8738-4b29e7c549e8",
"productndc": "53041-634",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "210149",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "100MG/5ML",
"product_no": "001",
"approval_date": "Aug 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": "ANDA210149",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20180821",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code G02CC01.
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