diphenhydramine hcl oral solution

Generic: diphenhydramine hcl oral

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

Drug Facts

Product Profile

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

diphenhydramine hydrochloride 25 mg/10mL

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7324
Product ID 0904-7324_425e484b-f7c7-4776-8d72-9a5bfb4f6dc5
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Marketing Start 2024-01-22
Marketing End 2026-07-31

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 09047324
Hyphenated Format 0904-7324

Supplemental Identifiers

RxCUI
1049906
UPC
0309047323418 0309047324668
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 hcl oral solution (source: ndc)
Generic Name diphenhydramine hcl oral (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/10mL
source: ndc
Packaging
  • 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (0904-7324-72) / 10 mL in 1 CUP, UNIT-DOSE (0904-7324-66)
source: ndc

Packages (1)

0904-7324-72 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (0904-7324-72) / 10 mL in 1 CUP, UNIT-DOSE (0904-7324-66)

Ingredients (1)

diphenhydramine hydrochloride (25 mg/10mL)

Linked Drug Pages (1)

Diphenhydramine HCl Oral Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "425e484b-f7c7-4776-8d72-9a5bfb4f6dc5", "openfda": {"upc": ["0309047323418", "0309047324668"], "unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["0f9015c9-a95a-5703-e063-6394a90a6ad2"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (0904-7324-72)  / 10 mL in 1 CUP, UNIT-DOSE (0904-7324-66)", "package_ndc": "0904-7324-72", "marketing_end_date": "20260731", "marketing_start_date": "20240122"}], "brand_name": "Diphenhydramine HCl Oral Solution", "product_id": "0904-7324_425e484b-f7c7-4776-8d72-9a5bfb4f6dc5", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0904-7324", "generic_name": "Diphenhydramine HCl Oral", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine HCl Oral Solution", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20260731", "marketing_start_date": "20240122"}