Home NDC 36800-585 Childrens Allergy Relief
Product NDC 36800-585
11-digit product format 368000585
Labeler code 36800
Product ID 36800-585_63271716-2607-4cd3-9165-6b4dfab4c079
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 2009-03-20
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 2027-12-31
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 Childrens Allergy Relief
Listing expiration 2027-12-31 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 36800-585-44 Childrens Allergy Relief 6 in 1 BLISTER PACK TABLET, CHEWABLE 6 11 36800-585-44 Childrens Allergy Relief 3 in 1 CARTON TABLET, CHEWABLE 3 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-585 CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [TOPCO ASSOCIATES, LLC] 10 Current NDC, Legacy NDC, 2 package rows 20240719_bfcabe02-7961-4407-a748-8cd087731398.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 36800-585-44 36800058544 3 BLISTER PACK in 1 CARTON (36800-585-44) / 6 TABLET, CHEWABLE in 1 BLISTER PACK 3 blister pack 2009-03-20 0000-00-00 No No Current