Home NDC 37808-012 Allergy
Product NDC 37808-012
11-digit product format 378080012
Labeler code 37808
Product ID 37808-012_9e60c1a8-4250-402a-8cd8-cb77b9b576ba
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form LIQUID
Route ORAL
Labeler H E B
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-02-29
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 Allergy
Brand name suffix Childrens
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 37808-012-08 AllergyChildrens 1 in 1 BOX LIQUID 1 7 37808-012-08 AllergyChildrens 237 mL in 1 BOTTLE, PLASTIC LIQUID 237 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 37808-012 ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [H E B] 7 Current NDC, Legacy NDC, 2 package rows 20240410_ab28cbc4-7a6f-46e9-8616-be78e8cb24fe.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 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 37808-012-08 37808001208 1 BOTTLE, PLASTIC in 1 BOX (37808-012-08) / 237 mL in 1 BOTTLE, PLASTIC 2016-02-29 0000-00-00 No No Current