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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

  • ndc11
    8256800164
    118 mL in 1 BOTTLE (82568-0016-4)
  • ndc11
    8256800166
    473 mL in 1 BOTTLE (82568-0016-6)
  • ndc11
    8256800168
    236 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

Other records sharing ATC code D04AA32.

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