Home NDC 41520-956-09 Acetaminophen PM
Product NDC 41520-956
Requested package NDC 41520-956-09
11-digit product format 415200956
Labeler code 41520
Product ID 41520-956_6df29ac8-5284-44ed-967d-88df30466636
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl
Dosage form TABLET, COATED
Route ORAL
Labeler FOODHOLD U.S.A., LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2007-12-17
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 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 Acetaminophen PM
Brand name suffix Extra Strength
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41520-956-09 Acetaminophen PMExtra Strength 20 in 1 BOTTLE, PLASTIC TABLET, COATED 20 13 41520-956-09 Acetaminophen PMExtra Strength 1 in 1 CARTON TABLET, COATED 1 13 41520-956-31 Acetaminophen PMExtra Strength 1 in 1 CARTON TABLET, COATED 1 13 41520-956-31 Acetaminophen PMExtra Strength 80 in 1 BOTTLE, PLASTIC TABLET, COATED 80 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41520-956 ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [FOODHOLD U.S.A., LLC] 12 Current NDC, Legacy NDC, 4 package rows 20240920_fdd7ce80-d6be-41b9-affd-d024cf306b50.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 78 · 1,552 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 41520-956-09 41520095609 1 BOTTLE, PLASTIC in 1 CARTON (41520-956-09) / 20 TABLET, COATED in 1 BOTTLE, PLASTIC 2007-12-17 0000-00-00 No No Current