topcare childrens allergy chews

Generic: diphenhydramine hcl

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

Drug Facts

Product Profile

Brand Name topcare childrens allergy chews
Generic Name diphenhydramine hcl
Labeler topco associates, llc
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 12.5 mg/1

Manufacturer
Topco Associates, LLC

Identifiers & Regulatory

Product NDC 76162-201
Product ID 76162-201_431146ca-c8d1-8d10-e063-6294a90a4a0c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-05-16

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 76162201
Hyphenated Format 76162-201

Supplemental Identifiers

RxCUI
1049900
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 childrens allergy chews (source: ndc)
Generic Name diphenhydramine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (76162-201-20) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
source: ndc

Packages (1)

76162-201-20 2 BLISTER PACK in 1 CARTON (76162-201-20) / 10 TABLET, CHEWABLE in 1 BLISTER PACK

Ingredients (1)

diphenhydramine hydrochloride (12.5 mg/1)

Linked Drug Pages (1)

TOPCARE Childrens Allergy Chews ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "431146ca-c8d1-8d10-e063-6294a90a4a0c", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049900"], "spl_set_id": ["b5e15dd1-6e99-411c-9183-8a4265eae404"], "manufacturer_name": ["Topco Associates, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (76162-201-20)  / 10 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "76162-201-20", "marketing_start_date": "20250516"}], "brand_name": "TOPCARE Childrens Allergy Chews", "product_id": "76162-201_431146ca-c8d1-8d10-e063-6294a90a4a0c", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "76162-201", "generic_name": "Diphenhydramine HCl", "labeler_name": "Topco Associates, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TOPCARE", "brand_name_suffix": "Childrens Allergy Chews", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250516", "listing_expiration_date": "20261231"}