diphenhydramine hcl

Generic: diphenhydramine hcl

Labeler: aarna usa inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hcl
Generic Name diphenhydramine hcl
Labeler aarna usa inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
AARNA USA INC.

Identifiers & Regulatory

Product NDC 82568-0004
Product ID 82568-0004_365baf41-5399-4fd7-e063-6294a90a81e1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-12-06

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 825680004
Hyphenated Format 82568-0004

Supplemental Identifiers

RxCUI
1020477 1049909
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 (source: ndc)
Generic Name diphenhydramine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (82568-0004-1)
  • 1000 CAPSULE in 1 BOTTLE (82568-0004-2)
source: ndc

Packages (2)

82568-0004-1 100 CAPSULE in 1 BOTTLE (82568-0004-1) 82568-0004-2 1000 CAPSULE in 1 BOTTLE (82568-0004-2)

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Diphenhydramine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "365baf41-5399-4fd7-e063-6294a90a81e1", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1020477", "1049909"], "spl_set_id": ["365bb414-8425-a900-e063-6394a90aa887"], "manufacturer_name": ["AARNA USA INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (82568-0004-1)", "package_ndc": "82568-0004-1", "marketing_start_date": "20250530"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (82568-0004-2)", "package_ndc": "82568-0004-2", "marketing_start_date": "20250530"}], "brand_name": "Diphenhydramine HCl", "product_id": "82568-0004_365baf41-5399-4fd7-e063-6294a90a81e1", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "82568-0004", "generic_name": "Diphenhydramine HCl", "labeler_name": "AARNA USA INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine HCl", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241206", "listing_expiration_date": "20261231"}