Home NDC 51316-863 Pain Reliever PM
Product NDC 51316-863
11-digit product format 513160863
Labeler code 51316
Product ID 51316-863_48a220ac-6d01-435d-bcb2-d4b88fba25fa
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCL
Dosage form TABLET, COATED
Route ORAL
Labeler CVS PHARMACY, INC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-15
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 Pain Reliever 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51316-863-50 Pain Reliever PM 500 in 1 BOTTLE, PLASTIC TABLET, COATED 500 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-863 PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [CVS PHARMACY, INC] 2 Current NDC, 1 package rows 20250206_17922df7-7867-4300-bd99-55aee7b60606.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 Sample Exclude flag Status 51316-863-50 51316086350 500 TABLET, COATED in 1 BOTTLE, PLASTIC (51316-863-50) 2024-09-15 No No Current