🇺🇸
United States · US · US:21130-228_09fc3572-d282-478d-ba22-70690f615e65
Ibuprofen and Diphenhydramine Citrate
Orange BookUNIISPLATC D04AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBetter Living Brands, LLC
CountryUS (United States)
ATC codeD04AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1121130228121 BOTTLE in 1 CARTON (21130-228-12) / 40 TABLET, COATED in 1 BOTTLE
- ndc1121130228181 BOTTLE in 1 CARTON (21130-228-18) / 80 TABLET, COATED in 1 BOTTLE
- ndc1121130228231 BOTTLE in 1 CARTON (21130-228-23) / 120 TABLET, COATED in 1 BOTTLE
- ndc1121130228731 BOTTLE in 1 CARTON (21130-228-73) / 20 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": "21130-228_09fc3572-d282-478d-ba22-70690f615e65",
"productndc": "21130-228",
"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 and Diphenhydramine Citrate",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA216204",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen and Diphenhydramine Citrate",
"start_marketing_date": "20231115",
"active_numerator_strength": "38; 200"
}Related drugs
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