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United States · US · US:0121-1022_d1635350-9966-4795-9bc2-6cf2b690eaec
Dye Free Childrens Ibuprofen
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPAI Holdings, LLC dba PAI Pharma
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11012110220010 CUP, UNIT-DOSE in 1 CASE (0121-1022-00) / 5 mL in 1 CUP, UNIT-DOSE
- ndc11012110220510 CUP, UNIT-DOSE in 1 TRAY (0121-1022-05) / 5 mL in 1 CUP, UNIT-DOSE
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": {
"46846abe-062d-a11f-e063-6294a90a73f3": {
"match": "brand_token",
"title": "DYE FREE REGULAR STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) SUSPENSION [WALMART INC.]",
"spl_version": "2",
"published_date": "2026-02-26"
}
},
"productid": "0121-1022_d1635350-9966-4795-9bc2-6cf2b690eaec",
"productndc": "0121-1022",
"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": "Dye Free Childrens Ibuprofen",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA210602",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20231103",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code G02CC01.
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