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United States · US · US:55758-304_ac3c264f-da36-a474-e053-2a95a90abdad
Dolex Children
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPharmadel LLC
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1155758304041 BOTTLE in 1 CARTON (55758-304-04) / 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": {
"0543420d-a250-065d-e063-6294a90a005e": {
"match": "brand_token",
"title": "DOLEX FLEX (IBUPROFEN) CAPSULE, LIQUID FILLED [PHARMADEL LLC]",
"spl_version": "5",
"published_date": "2026-03-23"
}
},
"productid": "55758-304_ac3c264f-da36-a474-e053-2a95a90abdad",
"productndc": "55758-304",
"dosage_form": "LIQUID",
"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": "Dolex Children",
"active_ingred_unit": "mg/100mL",
"application_number": "ANDA210602",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20200807",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code G02CC01.
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