sleep aid

Generic: diphenhydramine hcl

Labeler: topco associates, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sleep aid
Generic Name diphenhydramine hcl
Labeler topco associates, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Topco Associates, LLC

Identifiers & Regulatory

Product NDC 36800-672
Product ID 36800-672_cc763156-e5c5-4101-9584-5f63ac4d0907
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2015-07-24

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 36800672
Hyphenated Format 36800-672

Supplemental Identifiers

RxCUI
1049630
UPC
0036800495821
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
  • 200 TABLET, FILM COATED in 1 BOTTLE (36800-672-06)
source: ndc

Packages (1)

36800-672-06 200 TABLET, FILM COATED in 1 BOTTLE (36800-672-06)

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": "cc763156-e5c5-4101-9584-5f63ac4d0907", "openfda": {"upc": ["0036800495821"], "unii": ["TC2D6JAD40"], "rxcui": ["1049630"], "spl_set_id": ["57a81e24-ef0d-4143-b266-71e2d4be7617"], "manufacturer_name": ["Topco Associates, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200 TABLET, FILM COATED in 1 BOTTLE (36800-672-06)", "package_ndc": "36800-672-06", "marketing_start_date": "20150724"}], "brand_name": "Sleep Aid", "product_id": "36800-672_cc763156-e5c5-4101-9584-5f63ac4d0907", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "36800-672", "generic_name": "Diphenhydramine HCl", "labeler_name": "Topco Associates, LLC", "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": "20150724", "listing_expiration_date": "20261231"}