topcare health nighttime maximum strength sleep aid

Generic: diphenhydramine hydrochloride

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

Drug Facts

Product Profile

Brand Name topcare health nighttime maximum strength sleep aid
Generic Name diphenhydramine hydrochloride
Labeler topco associates llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 50 mg/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-438
Product ID 76162-438_267da9a1-6c85-4316-9aad-3fe5762c347a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2025-08-01

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 76162438
Hyphenated Format 76162-438

Supplemental Identifiers

RxCUI
1020477
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 topcare health nighttime maximum strength sleep aid (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 96 CAPSULE, LIQUID FILLED in 1 BOTTLE (76162-438-96)
source: ndc

Packages (1)

76162-438-96 96 CAPSULE, LIQUID FILLED in 1 BOTTLE (76162-438-96)

Ingredients (1)

diphenhydramine hydrochloride (50 mg/1)

Linked Drug Pages (1)

TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "267da9a1-6c85-4316-9aad-3fe5762c347a", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1020477"], "spl_set_id": ["2ea0b2cf-f055-11f6-e063-6394a90a5364"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "96 CAPSULE, LIQUID FILLED in 1 BOTTLE (76162-438-96)", "package_ndc": "76162-438-96", "marketing_start_date": "20250801"}], "brand_name": "TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid", "product_id": "76162-438_267da9a1-6c85-4316-9aad-3fe5762c347a", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "76162-438", "generic_name": "Diphenhydramine hydrochloride", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250801", "listing_expiration_date": "20261231"}