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United States · US · US:58602-814_8cd3b0a3-8a94-4cca-a6a7-f144a826f122
Diphenhydramine HCl and Ibuprofen
Orange BookUNIISPLATC D04AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurohealth LLC
CountryUS (United States)
ATC codeD04AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc1158602814101 BOTTLE in 1 CARTON (58602-814-10) / 32 CAPSULE, LIQUID FILLED in 1 BOTTLE
- ndc1158602814121 BOTTLE in 1 CARTON (58602-814-12) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
- ndc1158602814181 BOTTLE in 1 CARTON (58602-814-18) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE
- ndc115860281423120 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-814-23)
- ndc115860281430160 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-814-30)
- ndc1158602814731 BOTTLE in 1 CARTON (58602-814-73) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDE
RxCUI 1362
Orange Book
A210676
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "TC2D6JAD40",
"rxcui": "1362",
"inchikey": "PCHPORCSPXIHLZ-UHFFFAOYSA-N",
"display_name": "DIPHENHYDRAMINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"48ede5ab-207b-cf0c-e063-6394a90a419f": {
"match": "brand_token",
"title": "DIPHENHYDRAMINE ORAL SOLUTION (DIPHENHYDRAMINE HCL12.5MG/5ML) SOLUTION [ALDAMA PHARMACEUTICALS, INC]",
"spl_version": "3",
"published_date": "2026-06-02"
}
},
"productid": "58602-814_8cd3b0a3-8a94-4cca-a6a7-f144a826f122",
"productndc": "58602-814",
"dosage_form": "CAPSULE, LIQUID FILLED",
"orange_book": {
"appl_no": "210676",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "25MG;EQ 200MG FREE ACID AND POTASSIUM SALT",
"product_no": "001",
"approval_date": "Feb 14, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN",
"proprietary_name": "Diphenhydramine HCl and Ibuprofen",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA210676",
"marketing_category": "ANDA",
"nonproprietary_name": "Diphenhydramine HCl and Ibuprofen",
"start_marketing_date": "20190214",
"active_numerator_strength": "25; 200"
}Related drugs
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