Home NDC 76162-201 TOPCARE
Product NDC 76162-201
11-digit product format 761620201
Labeler code 76162
Product ID 76162-201_431146ca-c8d1-8d10-e063-6294a90a4a0c
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Topco Associates, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-16
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 12.5 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base TOPCARE
Brand name suffix Childrens Allergy Chews
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049900 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76162-201-20 TOPCAREChildrens Allergy Chews 2 in 1 CARTON TABLET, CHEWABLE 2 2 76162-201-20 TOPCAREChildrens Allergy Chews 10 in 1 BLISTER PACK TABLET, CHEWABLE 10 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 76162-201-20 76162020120 2 BLISTER PACK in 1 CARTON (76162-201-20) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 2 blister pack 2025-05-16 No No Current