sleep aid

Generic: diphenhydramine hydrochloride

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

Drug Facts

Product Profile

Brand Name sleep aid
Generic Name diphenhydramine hydrochloride
Labeler company name: topco associates, llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Company name: Topco Associates, LLC

Identifiers & Regulatory

Product NDC 76162-911
Product ID 76162-911_4279e0bd-a592-d469-e063-6294a90aff1b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2024-09-26

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 76162911
Hyphenated Format 76162-911

Supplemental Identifiers

RxCUI
1049909
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 M010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (76162-911-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (76162-911-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (76162-911-48) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (3)

76162-911-12 1 BLISTER PACK in 1 CARTON (76162-911-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 76162-911-24 2 BLISTER PACK in 1 CARTON (76162-911-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 76162-911-48 4 BLISTER PACK in 1 CARTON (76162-911-48) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

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": "4279e0bd-a592-d469-e063-6294a90aff1b", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049909"], "spl_set_id": ["7aec7b1b-39dc-4e99-9f92-d45af0a4a6ec"], "manufacturer_name": ["Company name: Topco Associates, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (76162-911-12)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "76162-911-12", "marketing_start_date": "20240926"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (76162-911-24)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "76162-911-24", "marketing_start_date": "20240926"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (76162-911-48)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "76162-911-48", "marketing_start_date": "20240926"}], "brand_name": "SLEEP AID", "product_id": "76162-911_4279e0bd-a592-d469-e063-6294a90aff1b", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "76162-911", "generic_name": "DIPHENHYDRAMINE HYDROCHLORIDE", "labeler_name": "Company 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": "20240926", "listing_expiration_date": "20261231"}