Home NDC 72288-437 basic care acetaminophen pm
Product NDC 72288-437
11-digit product format 722880437
Labeler code 72288
Product ID 72288-437_6c749fda-de71-476d-a163-63f53d2c06df
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amazon.com Services LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-08-11
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 basic care acetaminophen pm
Listing expiration 2027-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72288-437-78 basic care acetaminophen pm 1 in 1 CARTON TABLET, FILM COATED 1 2 72288-437-78 basic care acetaminophen pm 100 in 1 BOTTLE TABLET, FILM COATED 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72288-437 BASIC CARE ACETAMINOPHEN PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [AMAZON.COM SERVICES LLC] 2 Current NDC, Legacy NDC, 2 package rows 20240722_64a0084a-e29e-4c1a-8704-13a3e1238f76.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 68 of 79 · 1,579 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 72288-437-78 72288043778 1 BOTTLE in 1 CARTON (72288-437-78) / 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2021-08-11 0000-00-00 No No Current