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United States · US · US:52412-910_3cd2cd8d-d5cd-4eaf-9e60-980a7f62a3b8
Pediacare Childrens Ibuprofen Berry
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1152412910041 BOTTLE in 1 CARTON (52412-910-04) / 118 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A210602
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": {
"596372c7-eca3-4527-8e22-ab0751e2526b": {
"match": "brand_token",
"title": "PEDIACARE CHILDRENS ACETAMINOPHEN GRAPE (ACETAMINOPHEN) SUSPENSION [RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH]",
"spl_version": "3",
"published_date": "2025-01-01"
}
},
"productid": "52412-910_3cd2cd8d-d5cd-4eaf-9e60-980a7f62a3b8",
"productndc": "52412-910",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "210602",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "100MG/5ML",
"product_no": "001",
"approval_date": "Nov 23, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Pediacare Childrens Ibuprofen Berry",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA210602",
"marketing_category": "ANDA",
"nonproprietary_name": "IBUPROFEN",
"start_marketing_date": "20230103",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code G02CC01.
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