sleep aid

Generic: diphenhydramine hydrochloride

Labeler: velocity pharma llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH FINAL Inactive Finished

Drug Facts

Product Profile

Brand Name sleep aid
Generic Name diphenhydramine hydrochloride
Labeler velocity pharma llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Velocity Pharma LLC

Identifiers & Regulatory

Product NDC 76168-015
Product ID 76168-015_6c311047-4bf2-44ad-e053-2a91aa0ad047
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH FINAL
Application Number part338
Listing Expiration 2026-12-31
Marketing Start 2018-05-14

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 76168015
Hyphenated Format 76168-015

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 hydrochloride (source: ndc)
Application Number part338 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (76168-015-07) / 36 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (76168-015-12) / 100 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

76168-015-07 1 BOTTLE in 1 CARTON (76168-015-07) / 36 TABLET, FILM COATED in 1 BOTTLE 76168-015-12 1 BOTTLE in 1 CARTON (76168-015-12) / 100 TABLET, FILM COATED in 1 BOTTLE

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": "6c311047-4bf2-44ad-e053-2a91aa0ad047", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049630"], "spl_set_id": ["035454a1-d23b-4faf-8fac-a59fc77ce18c"], "manufacturer_name": ["Velocity Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (76168-015-07)  / 36 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "76168-015-07", "marketing_start_date": "20180514"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (76168-015-12)  / 100 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "76168-015-12", "marketing_start_date": "20180514"}], "brand_name": "Sleep Aid", "product_id": "76168-015_6c311047-4bf2-44ad-e053-2a91aa0ad047", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "76168-015", "generic_name": "diphenhydramine hydrochloride", "labeler_name": "Velocity Pharma LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sleep Aid", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "part338", "marketing_category": "OTC MONOGRAPH FINAL", "marketing_start_date": "20180514", "listing_expiration_date": "20261231"}