topcare sleep aid nighttime

Generic: diphenhydramine hydrochloride

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

Drug Facts

Product Profile

Brand Name topcare sleep aid nighttime
Generic Name diphenhydramine hydrochloride
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 36800-431
Product ID 36800-431_b0cba6ea-b6ae-42a0-aaae-055d03fb8254
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M010
Listing Expiration 2026-12-31
Marketing Start 2001-09-11

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 36800431
Hyphenated Format 36800-431

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 topcare sleep aid nighttime (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
  • 12 BLISTER PACK in 1 CARTON (36800-431-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK
  • 24 BLISTER PACK in 1 CARTON (36800-431-67) / 2 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (36800-431-78) / 100 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (3)

36800-431-62 12 BLISTER PACK in 1 CARTON (36800-431-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK 36800-431-67 24 BLISTER PACK in 1 CARTON (36800-431-67) / 2 TABLET, FILM COATED in 1 BLISTER PACK 36800-431-78 1 BOTTLE in 1 CARTON (36800-431-78) / 100 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

topcare sleep aid nighttime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b0cba6ea-b6ae-42a0-aaae-055d03fb8254", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049630"], "spl_set_id": ["30284271-0411-4abf-bc62-d956dc794432"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (36800-431-62)  / 2 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "36800-431-62", "marketing_start_date": "20010911"}, {"sample": false, "description": "24 BLISTER PACK in 1 CARTON (36800-431-67)  / 2 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "36800-431-67", "marketing_start_date": "20040127"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (36800-431-78)  / 100 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "36800-431-78", "marketing_start_date": "20170913"}], "brand_name": "topcare sleep aid nighttime", "product_id": "36800-431_b0cba6ea-b6ae-42a0-aaae-055d03fb8254", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "36800-431", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare sleep aid", "brand_name_suffix": "nighttime", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M010", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20010911", "listing_expiration_date": "20261231"}