🇺🇸
United States · US · US:55111-565_d2953b94-9244-2c86-ac0c-7610dd1e7963
Ibuprofen and Diphenhydramine Citrate
Orange BookUNIISPLATC D04AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories Limited
CountryUS (United States)
ATC codeD04AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 8
- ndc1155111565051 BOTTLE in 1 CARTON (55111-565-05) / 500 TABLET in 1 BOTTLE
- ndc1155111565141 BOTTLE in 1 CARTON (55111-565-14) / 20 TABLET in 1 BOTTLE
- ndc1155111565181 BOTTLE in 1 CARTON (55111-565-18) / 180 TABLET in 1 BOTTLE
- ndc1155111565301 BOTTLE in 1 CARTON (55111-565-30) / 30 TABLET in 1 BOTTLE
- ndc1155111565401 BOTTLE in 1 CARTON (55111-565-40) / 40 TABLET in 1 BOTTLE
- ndc1155111565801 BOTTLE in 1 CARTON (55111-565-80) / 80 TABLET in 1 BOTTLE
- ndc1155111565901 BOTTLE in 1 CARTON (55111-565-90) / 90 TABLET in 1 BOTTLE
- ndc1155111565922500 TABLET in 1 POUCH (55111-565-92)
Annotations
UNII (FDA Substance ID)
4OD433S209
DIPHENHYDRAMINE CITRATE
RxCUI 82004
Orange Book
A090619
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": "55111-565_d2953b94-9244-2c86-ac0c-7610dd1e7963",
"productndc": "55111-565",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "090619",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "38MG;200MG",
"product_no": "001",
"approval_date": "Jul 8, 2009"
}
],
"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": "ANDA090619",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen and Diphenhydramine Citrate",
"start_marketing_date": "20100131",
"active_numerator_strength": "38; 200"
}Related drugs
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