sleep aid

Generic: diphenhydramine hcl

Labeler: amerisource bergen
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sleep aid
Generic Name diphenhydramine hcl
Labeler amerisource bergen
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Amerisource Bergen

Identifiers & Regulatory

Product NDC 46122-651
Product ID 46122-651_2d8a61fe-d753-42a5-bb9b-91d53244e551
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2020-07-29

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 46122651
Hyphenated Format 46122-651

Supplemental Identifiers

RxCUI
1049630
UPC
0087701433405
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 (source: ndc)
Application Number M010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (46122-651-62) / 12 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BOTTLE, PLASTIC in 1 CARTON (46122-651-78) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

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": "2d8a61fe-d753-42a5-bb9b-91d53244e551", "openfda": {"upc": ["0087701433405"], "unii": ["TC2D6JAD40"], "rxcui": ["1049630"], "spl_set_id": ["147adc14-ca7c-45f5-9925-ea569edbfe96"], "manufacturer_name": ["Amerisource Bergen"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (46122-651-62)  / 12 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "46122-651-62", "marketing_start_date": "20200729"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (46122-651-78)  / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "46122-651-78", "marketing_start_date": "20200729"}], "brand_name": "Sleep Aid", "product_id": "46122-651_2d8a61fe-d753-42a5-bb9b-91d53244e551", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "46122-651", "generic_name": "Diphenhydramine HCl", "labeler_name": "Amerisource Bergen", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sleep Aid", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200729", "listing_expiration_date": "20261231"}