diphenhydramine hcl

Generic: diphenhydramine hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hcl
Generic Name diphenhydramine hydrochloride
Labeler major pharmaceuticals
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/10mL

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7559
Product ID 0904-7559_45b07e82-0ce9-492f-8303-65c992c7dc32
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-07-15

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 09047559
Hyphenated Format 0904-7559

Supplemental Identifiers

RxCUI
1049906
UPC
0309047559664 0309047560417
UNII
TC2D6JAD40

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 hcl (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/10mL
source: ndc
Packaging
  • 10 TRAY in 1 CASE (0904-7559-72) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0904-7559-66)
source: ndc

Packages (1)

0904-7559-72 10 TRAY in 1 CASE (0904-7559-72) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0904-7559-66)

Ingredients (1)

diphenhydramine hydrochloride (25 mg/10mL)

Linked Drug Pages (1)

Diphenhydramine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "45b07e82-0ce9-492f-8303-65c992c7dc32", "openfda": {"upc": ["0309047559664", "0309047560417"], "unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["1b591e27-b00b-41c8-9fe9-c633aba09134"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (0904-7559-72)  / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0904-7559-66)", "package_ndc": "0904-7559-72", "marketing_start_date": "20250801"}], "brand_name": "Diphenhydramine HCl", "product_id": "0904-7559_45b07e82-0ce9-492f-8303-65c992c7dc32", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0904-7559", "generic_name": "diphenhydramine hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine HCl", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250715", "listing_expiration_date": "20261231"}