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United States · US · US:30142-278_cc3a78e5-52f9-424b-ab27-1c4ab644c735
Ibuprofen PM
Orange BookUNIISPLATC D04AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKROGER COMPANY
CountryUS (United States)
ATC codeD04AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1130142278801 BOTTLE in 1 CARTON (30142-278-80) / 80 TABLET, COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
4OD433S209
DIPHENHYDRAMINE CITRATE
RxCUI 82004
Orange Book
A216204
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": {
"aeee629b-255c-40d8-8e95-779aec00f723": {
"match": "brand_token",
"title": "IBUPROFEN TABLET [NORTHSTAR RX LLC]",
"spl_version": "1",
"published_date": "2026-06-02"
}
},
"productid": "30142-278_cc3a78e5-52f9-424b-ab27-1c4ab644c735",
"productndc": "30142-278",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "216204",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "38MG;200MG",
"product_no": "001",
"approval_date": "May 31, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DIPHENHYDRAMINE CITRATE; IBUPROFEN",
"proprietary_name": "Ibuprofen PM",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA216204",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen and Diphenhydramine Citrate",
"start_marketing_date": "20240507",
"active_numerator_strength": "38; 200"
}Related drugs
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