diphenhydramine oral solution (73564-814)

Drug Facts

Product Profile

Brand Name diphenhydramine oral solution

Generic Name diphenhydramine kci12.5mg/5ml

Labeler aldama pharmaceuticals, inc

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

diphenhydramine hydrochloride 12.5 mg/5mL

Manufacturer

Aldama Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 73564-814

Product ID 73564-814_48edefbd-c340-be17-e063-6394a90a1c6b

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M012

Listing Expiration 2027-12-31

Marketing Start 2026-01-01

Pharmacologic Class

Classes

histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 73564814

Hyphenated Format 73564-814

Supplemental Identifiers

RxCUI

1049906

UNII

TC2D6JAD40

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name diphenhydramine oral solution (source: ndc)

Generic Name diphenhydramine kci12.5mg/5ml (source: ndc)

Application Number M012 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/5mL

source: ndc

Packaging

1 BOTTLE in 1 BOX (73564-814-16) / 473 mL in 1 BOTTLE

source: ndc

Packages (1)

73564-814-16 1 BOTTLE in 1 BOX (73564-814-16) / 473 mL in 1 BOTTLE

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/5mL)

Linked Drug Pages (1)

Diphenhydramine Oral Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "48edefbd-c340-be17-e063-6394a90a1c6b", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["48ede5ab-207b-cf0c-e063-6394a90a419f"], "manufacturer_name": ["Aldama Pharmaceuticals, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (73564-814-16)  / 473 mL in 1 BOTTLE", "package_ndc": "73564-814-16", "marketing_start_date": "20260101"}], "brand_name": "Diphenhydramine Oral Solution", "product_id": "73564-814_48edefbd-c340-be17-e063-6394a90a1c6b", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "73564-814", "generic_name": "Diphenhydramine KCI12.5mg/5mL", "labeler_name": "Aldama Pharmaceuticals, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine Oral Solution", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20260101", "listing_expiration_date": "20271231"}