diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

Labeler: prodose, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
Generic Name diphenhydramine hydrochloride
Labeler prodose, inc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 50 mg/1

Manufacturer
Prodose, Inc.

Identifiers & Regulatory

Product NDC 68210-5057
Product ID 68210-5057_474d365f-143c-8019-e063-6294a90ab3ea
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2025-07-30

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 682105057
Hyphenated Format 68210-5057

Supplemental Identifiers

RxCUI
1020477
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 M010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 2 POUCH in 1 BOX (68210-5057-1) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH
source: ndc

Packages (1)

68210-5057-1 2 POUCH in 1 BOX (68210-5057-1) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH

Ingredients (1)

diphenhydramine hydrochloride (50 mg/1)

Linked Drug Pages (1)

DIPHENHYDRAMINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "474d365f-143c-8019-e063-6294a90ab3ea", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1020477"], "spl_set_id": ["3b1ea33b-8460-31cf-e063-6394a90a5534"], "manufacturer_name": ["Prodose, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 POUCH in 1 BOX (68210-5057-1)  / 3000 CAPSULE, LIQUID FILLED in 1 POUCH", "package_ndc": "68210-5057-1", "marketing_start_date": "20250730"}], "brand_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "product_id": "68210-5057_474d365f-143c-8019-e063-6294a90ab3ea", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68210-5057", "generic_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "labeler_name": "Prodose, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DIPHENHYDRAMINE HYDROCHLORIDE", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250730", "listing_expiration_date": "20261231"}