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United States · US · US:55758-014_4d7a9ecd-d071-a923-e063-6394a90ad412
Dolex Flex
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 · 2
- ndc1155758014201 BOTTLE in 1 CARTON (55758-014-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
- ndc11557580149950 PACKET in 1 CARTON (55758-014-99) / 2 CAPSULE, LIQUID FILLED in 1 PACKET (55758-014-02)
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A078682
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": "55758-014_4d7a9ecd-d071-a923-e063-6394a90ad412",
"productndc": "55758-014",
"dosage_form": "CAPSULE, LIQUID FILLED",
"orange_book": {
"appl_no": "078682",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 200MG FREE ACID AND POTASSIUM SALT",
"product_no": "001",
"approval_date": "Mar 24, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Dolex Flex",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078682",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20230901",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code G02CC01.
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