FDA.reportPublic FDA data

Extra Strength Acetaminophen

Product NDC
68788-4065
11-digit product format
687884065
Labeler code
68788
Product ID
68788-4065_b25faa8c-2d13-450a-970f-81c17a633030
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-28
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Extra Strength Acetaminophen
Listing expiration
2027-12-31

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
68788-4065-1Extra Strength Acetaminophen100 in 1 BOTTLETABLET1001
68788-4065-2Extra Strength Acetaminophen20 in 1 BOTTLETABLET201
68788-4065-3Extra Strength Acetaminophen30 in 1 BOTTLETABLET301
68788-4065-5Extra Strength Acetaminophen50 in 1 BOTTLETABLET501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4065-1EA - Each68788-40655b36fc71-fd85-4f1f-ad96-e46ef8ce0d3112026-03-17
68788-4065-2EA - Each68788-406506d8b749-bb40-4db9-bf51-c55cf828f77612026-03-17
68788-4065-3EA - Each68788-406523bfa438-b46b-41ff-a836-2a764998bc7612026-03-17
68788-4065-5EA - Each68788-40650c6b56d0-0b26-49db-a5dc-a12fe6781b6112026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNb25faa8c-2d13-450a-970f-81c17a6330301
198440acetaminophen 500 MG Oral TabletSCDb25faa8c-2d13-450a-970f-81c17a6330301
198440APAP 500 MG Oral TabletSYb25faa8c-2d13-450a-970f-81c17a6330301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-4065-168788406501100 TABLET in 1 BOTTLE (68788-4065-1) 100 tablet2026-01-28NoNoHistorical
68788-4065-26878840650220 TABLET in 1 BOTTLE (68788-4065-2) 20 tablet2026-01-28NoNoHistorical
68788-4065-36878840650330 TABLET in 1 BOTTLE (68788-4065-3) 30 tablet2026-01-28NoNoHistorical
68788-4065-56878840650550 TABLET in 1 BOTTLE (68788-4065-5) 50 tablet2026-01-28NoNoHistorical