Home NDC 49580-0292 Childrens Allergy
Product NDC 49580-0292
11-digit product format 495800292
Labeler code 49580
Product ID 49580-0292_79fc4013-85e6-4276-bc54-26ac0951bd0e
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form LIQUID
Route ORAL
Labeler P & L Development, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-03-31
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 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
Listing expiration 2027-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49580-0292-2 Childrens Allergy 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 8 49580-0292-4 Childrens Allergy 1 in 1 BOX LIQUID 1 8 49580-0292-4 Childrens Allergy 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49580-0292 CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC] 7 Current NDC, Legacy NDC, 3 package rows 20240217_8559be55-8b00-4353-8e26-b5dff2ada806.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 49580-0292-2 49580029202 118 mL in 1 BOTTLE, PLASTIC (49580-0292-2) 118 ml 2015-03-31 0000-00-00 No No Current 49580-0292-4 49580029204 1 BOTTLE, PLASTIC in 1 BOX (49580-0292-4) / 118 mL in 1 BOTTLE, PLASTIC 2015-03-31 0000-00-00 No No Current