Home NDC 68391-659 berkley and jensen acetaminophen
Product NDC 68391-659
11-digit product format 683910659
Labeler code 68391
Product ID 68391-659_75ae2ae9-c96b-4833-b85b-efa02f8a0214
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET
Route ORAL
Labeler BJWC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-03-21
Substance ACETAMINOPHEN
Active strength 500 mg/1
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 berkley and jensen acetaminophen
Listing expiration 2027-12-31 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 68391-659-90 berkley and jensen acetaminophen 500 in 1 BOTTLE TABLET 500 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68391-659 BERKLEY AND JENSEN ACETAMINOPHEN (ACETAMINOPHEN) TABLET [BJWC] 2 Current NDC, 1 package rows 20241116_dee57d73-73ac-48bb-b1da-9971f1ff21c4.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 Units Marketing start Sample Exclude flag Status 68391-659-90 68391065990 500 TABLET in 1 BOTTLE (68391-659-90) 500 tablet 2023-03-21 No No Current