Home NDC 68391-863 Pain Reliever PM
Product NDC 68391-863
11-digit product format 683910863
Labeler code 68391
Product ID 68391-863_522cbc9a-9a80-4d40-b868-1334fa7a0a9c
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCL
Dosage form TABLET, COATED
Route ORAL
Labeler BJWC (Berkley & Jensen / BJ's)
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-11-29
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
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
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
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 68391-863-05 Pain Reliever PMExtra Strength 500 in 1 BOTTLE, PLASTIC TABLET, COATED 500 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68391-863 PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 4 Current NDC, Legacy NDC, 1 package rows 20240224_b20a08f3-c9c0-4bd9-8ce0-acb932b5bb86.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 39 of 79 · 1,579 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 68391-863-05 68391086305 500 TABLET, COATED in 1 BOTTLE, PLASTIC (68391-863-05) 2019-11-29 0000-00-00 No No Current