🇺🇸
United States · US · US:82568-0016_3404aa22-166f-5501-e063-6394a90a1e7a
DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML
UNIISPLATC D04AA32
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAARNA USA INC.
CountryUS (United States)
ATC codeD04AA32
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc118256800164118 mL in 1 BOTTLE (82568-0016-4)
- ndc118256800166473 mL in 1 BOTTLE (82568-0016-6)
- ndc118256800168236 mL in 1 BOTTLE (82568-0016-8)
Annotations
UNII (FDA Substance ID)
8GTS82S83M
DIPHENHYDRAMINE
RxCUI 3498
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "8GTS82S83M",
"rxcui": "3498",
"inchikey": "ZZVUWRFHKOJYTH-UHFFFAOYSA-N",
"display_name": "DIPHENHYDRAMINE",
"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": "82568-0016_3404aa22-166f-5501-e063-6394a90a1e7a",
"productndc": "82568-0016",
"dosage_form": "SOLUTION",
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DIPHENHYDRAMINE",
"proprietary_name": "DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML",
"active_ingred_unit": "mg/5mL",
"application_number": "M012",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML",
"start_marketing_date": "20250414",
"active_numerator_strength": "12.5"
}Related drugs
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