simply sleep

Generic: diphenhydramine hydrochloride

Labeler: kenvue brands llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name simply sleep
Generic Name diphenhydramine hydrochloride
Labeler kenvue brands llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-843
Product ID 50580-843_369b679c-4911-8ef8-e063-6394a90abd0a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2004-02-01

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 50580843
Hyphenated Format 50580-843

Supplemental Identifiers

RxCUI
1049630 1092466
UPC
0300450843104
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 simply sleep (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50580-843-12) / 100 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

50580-843-12 1 BOTTLE in 1 CARTON (50580-843-12) / 100 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Simply Sleep ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "369b679c-4911-8ef8-e063-6394a90abd0a", "openfda": {"upc": ["0300450843104"], "unii": ["TC2D6JAD40"], "rxcui": ["1049630", "1092466"], "spl_set_id": ["37c606b0-04d5-49f0-886a-3ee2c9b0e9cc"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-843-12)  / 100 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50580-843-12", "marketing_start_date": "20130410"}], "brand_name": "Simply Sleep", "product_id": "50580-843_369b679c-4911-8ef8-e063-6394a90abd0a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50580-843", "generic_name": "diphenhydramine hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Simply Sleep", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20040201", "listing_expiration_date": "20261231"}