Home NDC 0904-7533 Allergy Relief
Product NDC 0904-7533
11-digit product format 009047533
Labeler code 0904
Product ID 0904-7533_3648f1ee-b2d4-41d9-ac39-c8ec482a6e92
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form SOLUTION
Route ORAL
Labeler Major Pharmaceuticals
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-07
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 Relief
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0904-7533-15 Allergy ReliefChildrens 473 mL in 1 BOTTLE, PLASTIC SOLUTION 473 2 0904-7533-20 Allergy ReliefChildrens 1 in 1 CARTON SOLUTION 1 2 0904-7533-20 Allergy ReliefChildrens 118 mL in 1 BOTTLE, PLASTIC SOLUTION 118 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7533 ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) SOLUTION [MAJOR PHARMACEUTICALS] 1 Current NDC, 3 package rows 20250309_3a976e90-c6af-4414-984e-9987158c9e98.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 Units Marketing start Sample Exclude flag Status 0904-7533-15 00904753315 473 mL in 1 BOTTLE, PLASTIC (0904-7533-15) 473 ml 2025-03-07 No No Current 0904-7533-20 00904753320 1 BOTTLE, PLASTIC in 1 CARTON (0904-7533-20) / 118 mL in 1 BOTTLE, PLASTIC 2025-03-07 No No Current