sleep aid

Generic: diphenhydramine hcl 25 mg

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

Drug Facts

Product Profile

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

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Allegiant Health

Identifiers & Regulatory

Product NDC 69168-263
Product ID 69168-263_b9e7a97b-a3e9-427c-8cc5-9c94941409a1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2015-03-03

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 69168263
Hyphenated Format 69168-263

Supplemental Identifiers

RxCUI
1049630
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 sleep aid (source: ndc)
Generic Name diphenhydramine hcl 25 mg (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (69168-263-30)
  • 1 BAG in 1 CARTON (69168-263-54) / 16458 TABLET in 1 BAG
  • 24 TABLET in 1 BOX (69168-263-93)
  • 200 TABLET in 1 BOTTLE (69168-263-98)
source: ndc

Packages (4)

69168-263-30 30 TABLET in 1 BOTTLE (69168-263-30) 69168-263-54 1 BAG in 1 CARTON (69168-263-54) / 16458 TABLET in 1 BAG 69168-263-93 24 TABLET in 1 BOX (69168-263-93) 69168-263-98 200 TABLET in 1 BOTTLE (69168-263-98)

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Sleep Aid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b9e7a97b-a3e9-427c-8cc5-9c94941409a1", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049630"], "spl_set_id": ["dbbc535f-515a-4d9b-b799-34e60f5230bb"], "manufacturer_name": ["Allegiant Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (69168-263-30)", "package_ndc": "69168-263-30", "marketing_start_date": "20150303"}, {"sample": false, "description": "1 BAG in 1 CARTON (69168-263-54)  / 16458 TABLET in 1 BAG", "package_ndc": "69168-263-54", "marketing_start_date": "20250508"}, {"sample": false, "description": "24 TABLET in 1 BOX (69168-263-93)", "package_ndc": "69168-263-93", "marketing_start_date": "20150303"}, {"sample": false, "description": "200 TABLET in 1 BOTTLE (69168-263-98)", "package_ndc": "69168-263-98", "marketing_start_date": "20210723"}], "brand_name": "Sleep Aid", "product_id": "69168-263_b9e7a97b-a3e9-427c-8cc5-9c94941409a1", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69168-263", "generic_name": "Diphenhydramine HCl 25 mg", "labeler_name": "Allegiant Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sleep Aid", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150303", "listing_expiration_date": "20261231"}