FDA.reportPublic FDA data

BERKLEY AND JENSEN RAPID RELEASE ACETAMINOPHEN

Product NDC
68391-411
11-digit product format
683910411
Labeler code
68391
Product ID
68391-411_b0fb97e4-e927-4813-8133-c072fb4037f7
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
2025-09-04
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BERKLEY AND JENSEN RAPID RELEASE ACETAMINOPHEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui198440

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68391-411-79BERKLEY AND JENSEN RAPID RELEASE ACETAMINOPHEN400 in 1 BOTTLETABLET, FILM COATED4002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNe27b6637-ef32-44b5-a531-b6617d02fbbf2
198440acetaminophen 500 MG Oral TabletSCDe27b6637-ef32-44b5-a531-b6617d02fbbf2
198440APAP 500 MG Oral TabletSYe27b6637-ef32-44b5-a531-b6617d02fbbf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68391-411-7968391041179400 TABLET, FILM COATED in 1 BOTTLE (68391-411-79) 2025-09-04NoNoHistorical