Home NDC 46122-799 Extra Strength PM Pain Medicine
Product NDC 46122-799
11-digit product format 461220799
Labeler code 46122
Product ID 46122-799_23fbc0e1-3e01-acb4-e063-6394a90ac9db
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl
Dosage form TABLET
Route ORAL
Labeler Amerisource Bergen
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-01
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
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Extra Strength PM Pain Medicine
Listing expiration 2026-12-31 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 46122-799-69 Extra Strength PM Pain Medicine 50 in 1 BOTTLE TABLET 50 1 46122-799-69 Extra Strength PM Pain Medicine 1 in 1 CARTON TABLET 1 1 46122-799-70 Extra Strength PM Pain Medicine 100 in 1 BOTTLE TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46122-799 EXTRA STRENGTH PM PAIN MEDICINE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [AMERISOURCE BERGEN] 1 Current NDC, 3 package rows 20241010_23fbda2b-885b-ce00-e063-6294a90a586e.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 1 of 84 · 1,678 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 46122-799-69 46122079969 1 BOTTLE in 1 CARTON (46122-799-69) / 50 TABLET in 1 BOTTLE 1 bottle 2024-10-01 No No Current 46122-799-70 46122079970 100 TABLET in 1 BOTTLE (46122-799-70) 100 tablet 2024-10-01 No No Current