🇺🇸
United States · US · US:0573-0184_3e883935-a6b2-f5fc-e063-6294a90a7789
ADVIL COLD AND SINUS
Orange BookUNIISPLATC C01EB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHaleon US Holdings LLC
CountryUS (United States)
ATC codeC01EB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11057301841616 BLISTER PACK in 1 CARTON (0573-0184-16) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
- ndc11057301843232 BLISTER PACK in 1 CARTON (0573-0184-32) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
N021374
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": {
"a3c30dd2-75f3-4f8b-88d7-4a63dea5bad7": {
"match": "brand_token",
"title": "ADVIL PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [NAVAJO MANUFACTURING COMPANY INC.]",
"spl_version": "3",
"published_date": "2026-04-09"
}
},
"productid": "0573-0184_3e883935-a6b2-f5fc-e063-6294a90a7789",
"productndc": "0573-0184",
"dosage_form": "CAPSULE, LIQUID FILLED",
"orange_book": {
"appl_no": "021374",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 200MG FREE ACID AND POTASSIUM SALT;30MG",
"product_no": "001",
"approval_date": "May 30, 2002"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "ADVIL COLD AND SINUS",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA021374",
"marketing_category": "NDA",
"nonproprietary_name": "ibuprofen, pseudoephedrine hydrochloride",
"start_marketing_date": "20020530",
"active_numerator_strength": "200; 30"
}Related drugs
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