🇺🇸
United States · US · US:50580-563_39a34ab2-9fae-444e-e063-6294a90a9152
Motrin
Orange BookUNIISPLATC D04AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKenvue Brands LLC
CountryUS (United States)
ATC codeD04AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1150580563201 BOTTLE, PLASTIC in 1 CARTON (50580-563-20) / 20 TABLET, COATED in 1 BOTTLE, PLASTIC
- ndc1150580563801 BOTTLE, PLASTIC in 1 CARTON (50580-563-80) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
4OD433S209
DIPHENHYDRAMINE CITRATE
RxCUI 82004
Orange Book
A079113
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4OD433S209",
"rxcui": "82004",
"inchikey": "SPCKHVPPRJWQRZ-UHFFFAOYSA-N",
"display_name": "DIPHENHYDRAMINE CITRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c57f6ded-c0bd-45ae-823a-4c02ce334d98": {
"match": "brand_token",
"title": "MOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [KENVUE BRANDS LLC]",
"spl_version": "17",
"published_date": "2026-05-20"
}
},
"productid": "50580-563_39a34ab2-9fae-444e-e063-6294a90a9152",
"productndc": "50580-563",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "079113",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "38MG;200MG",
"product_no": "001",
"approval_date": "Dec 22, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DIPHENHYDRAMINE CITRATE; IBUPROFEN",
"proprietary_name": "Motrin",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA079113",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen and Diphenhydramine Citrate",
"start_marketing_date": "20100111",
"active_numerator_strength": "38; 200"
}Related drugs
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