diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

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

Drug Facts

Product Profile

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

diphenhydramine hydrochloride 12.5 mg/5mL

Manufacturer
Oncor Pharmaceuticals

Identifiers & Regulatory

Product NDC 83720-502
Product ID 83720-502_31583c7e-3649-d899-e063-6394a90aa63f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-03-27

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 83720502
Hyphenated Format 83720-502

Supplemental Identifiers

RxCUI
1049906
UPC
0383720502048 0383720502161
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 hydrochloride (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (83720-502-04)
  • 473 mL in 1 BOTTLE (83720-502-16)
source: ndc

Packages (2)

83720-502-04 118 mL in 1 BOTTLE (83720-502-04) 83720-502-16 473 mL in 1 BOTTLE (83720-502-16)

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/5mL)

Linked Drug Pages (1)

Diphenhydramine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "31583c7e-3649-d899-e063-6394a90aa63f", "openfda": {"upc": ["0383720502048", "0383720502161"], "unii": ["TC2D6JAD40"], "rxcui": ["1049906"], "spl_set_id": ["06ecba97-c790-4672-a8c3-f9caf6272d26"], "manufacturer_name": ["Oncor Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (83720-502-04)", "package_ndc": "83720-502-04", "marketing_start_date": "20250327"}, {"sample": false, "description": "473 mL in 1 BOTTLE (83720-502-16)", "package_ndc": "83720-502-16", "marketing_start_date": "20250327"}], "brand_name": "Diphenhydramine Hydrochloride", "product_id": "83720-502_31583c7e-3649-d899-e063-6394a90aa63f", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "83720-502", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Oncor Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine Hydrochloride", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250327", "listing_expiration_date": "20261231"}