🇺🇸
United States · US · US:83634-781_908025cf-e126-4241-b794-47d2fd90078e
Diphenhydramine
Orange BookUNIISPLATC D04AA32
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAvenacy, LLC
CountryUS (United States)
ATC codeD04AA32
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11836347810125 VIAL, SINGLE-DOSE in 1 CARTON (83634-781-01) / 1 mL in 1 VIAL, SINGLE-DOSE (83634-781-41)
Annotations
UNII (FDA Substance ID)
TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDE
RxCUI 1362
Orange Book
A205336
AP
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": "INTRAMUSCULAR; INTRAVENOUS",
"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": "83634-781_908025cf-e126-4241-b794-47d2fd90078e",
"productndc": "83634-781",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "205336",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "50MG/ML",
"product_no": "001",
"approval_date": "Jun 24, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DIPHENHYDRAMINE HYDROCHLORIDE",
"proprietary_name": "Diphenhydramine",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA205336",
"marketing_category": "ANDA",
"nonproprietary_name": "diphenhydramine hydrochloride",
"start_marketing_date": "20250901",
"active_numerator_strength": "50"
}Related drugs
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