Home NDC 0363-9085 EXTRA STRENGTH PAIN RELIEVER PM
Product NDC 0363-9085
11-digit product format 003639085
Labeler code 0363
Product ID 0363-9085_48d64463-5a70-6a97-e063-6294a90a6bd2
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler WALGREENS CO.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-04-13
Marketing end 2028-11-30
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 500; 25 mg/1; mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
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 EXTRA STRENGTH PAIN RELIEVER PM Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 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 1092189 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 0363-9085-15 EXTRA STRENGTH PAIN RELIEVER PM 15 in 1 BOTTLE TABLET 15 6 0363-9085-15 EXTRA STRENGTH PAIN RELIEVER PM 1 in 1 CARTON TABLET 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-9085 EXTRA STRENGTH PAIN RELIEVER PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [WALGREENS CO.] 5 Current NDC, 2 package rows 20250101_5a58d620-a0ec-48d7-92dd-3f3f78ec10ea.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 63 of 79 · 1,576 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 0363-9085-15 00363908515 1 BOTTLE in 1 CARTON (0363-9085-15) / 15 TABLET in 1 BOTTLE 1 bottle 2023-04-13 2028-11-30 No No Historical