Home NDC 62011-0420 Pain Reliever PM
Product NDC 62011-0420
11-digit product format 620110420
Labeler code 62011
Product ID 62011-0420_93fd7776-314e-462d-a576-d2f622d3b65b
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCL
Dosage form TABLET, COATED
Route ORAL
Labeler Strategic Sourcing Services LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-11-29
Marketing end 2026-11-29
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 Pain Reliever PM
Brand name suffix Extra Strength 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 62011-0420-1 Pain Reliever PMExtra Strength 50 in 1 BOTTLE, PLASTIC TABLET, COATED 50 5 62011-0420-1 Pain Reliever PMExtra Strength 1 in 1 BOX TABLET, COATED 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62011-0420 PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [STRATEGIC SOURCING SERVICES LLC] 4 Current NDC, Legacy NDC, 2 package rows 20240530_997eb228-09cb-47ad-acbb-363b05c67635.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 62011-0420-1 62011042001 1 BOTTLE, PLASTIC in 1 BOX (62011-0420-1) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC 2019-11-29 2026-11-29 No No Current