Home NDC 68391-004 Berkley and Jensen Pain Relief
Product NDC 68391-004
11-digit product format 683910004
Labeler code 68391
Product ID 68391-004_c7b92375-0d31-4457-9517-8722eb8e2f7a
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler BJWC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-11-30
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
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 Berkley and Jensen Pain Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198440 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68391-004-79 Berkley and Jensen Pain Relief 400 in 1 BOTTLE TABLET, FILM COATED 400 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68391-004 BERLEY AND JENSEN PAIN RELIEF (ACETAMINOPHEN) TABLET, FILM COATED [BJWC] 4 Current NDC, Legacy NDC, 1 package rows 20240418_d3ee3341-93b8-487c-921e-2892d213efbb.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 78 of 79 · 1,576 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 68391-004-79 68391000479 400 TABLET, FILM COATED in 1 BOTTLE (68391-004-79) 2015-11-30 0000-00-00 No No Current