Home NDC 36800-379 Topcare childrens allergy
Product NDC 36800-379
11-digit product format 368000379
Labeler code 36800
Product ID 36800-379_8febc051-c865-4f72-8389-84bdb89f1ee6
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Topco Associates LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 1987-12-15
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 12.5 mg/5mL
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 childrens allergy
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL
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 1049906 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-379-26 Topcare childrens allergy 118 mL in 1 BOTTLE SOLUTION 118 7 36800-379-26 Topcare childrens allergy 1 in 1 CARTON SOLUTION 1 7 36800-379-34 Topcare childrens allergy 1 in 1 CARTON SOLUTION 1 7 36800-379-34 Topcare childrens allergy 237 mL in 1 BOTTLE SOLUTION 237 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-379 TOPCARE CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [TOPCO ASSOCIATES LLC] 7 Current NDC, Legacy NDC, 4 package rows 20240724_6b784cde-3152-4421-a825-dd1fc601aa7a.zip
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 73 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-379-26 36800037926 1 BOTTLE in 1 CARTON (36800-379-26) / 118 mL in 1 BOTTLE 1 bottle 1987-12-15 0000-00-00 No No Current 36800-379-34 36800037934 1 BOTTLE in 1 CARTON (36800-379-34) / 237 mL in 1 BOTTLE 1 bottle 2003-11-18 0000-00-00 No No Current