diphenhydramine hcl 25mg

Generic: sleep aid

Labeler: allegiant health
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hcl 25mg
Generic Name sleep aid
Labeler allegiant health
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Allegiant Health

Identifiers & Regulatory

Product NDC 69168-002
Product ID 69168-002_36c028e5-005a-42eb-958c-9fed406827b3
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2021-11-23

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 69168002
Hyphenated Format 69168-002

Supplemental Identifiers

RxCUI
1049630
UPC
0852510005774
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 25mg (source: ndc)
Generic Name sleep aid (source: ndc)
Application Number M010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 24 TABLET, COATED in 1 CARTON (69168-002-93)
source: ndc

Packages (1)

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "36c028e5-005a-42eb-958c-9fed406827b3", "openfda": {"upc": ["0852510005774"], "unii": ["TC2D6JAD40"], "rxcui": ["1049630"], "spl_set_id": ["2890e4ba-d642-437d-8a86-24996a74e027"], "manufacturer_name": ["Allegiant Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 TABLET, COATED in 1 CARTON (69168-002-93)", "package_ndc": "69168-002-93", "marketing_start_date": "20211123"}], "brand_name": "Diphenhydramine HCl 25mg", "product_id": "69168-002_36c028e5-005a-42eb-958c-9fed406827b3", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69168-002", "generic_name": "Sleep Aid", "labeler_name": "Allegiant Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine HCl 25mg", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20211123", "listing_expiration_date": "20261231"}