FDA.reportPublic FDA data

Extra Strength Acetaminophen

Product NDC
68788-8873
11-digit product format
687888873
Labeler code
68788
Product ID
68788-8873_95f4b628-6d35-4f6b-91f9-b2d117f8e821
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
2025-05-16
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
Extra Strength 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
68788-8873-1Extra Strength Acetaminophen100 in 1 BOTTLETABLET1001
68788-8873-2Extra Strength Acetaminophen20 in 1 BOTTLETABLET201
68788-8873-3Extra Strength Acetaminophen30 in 1 BOTTLETABLET301
68788-8873-5Extra Strength Acetaminophen50 in 1 BOTTLETABLET501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8873-1EA - Each68788-8873bf1f21d2-a608-48e0-a531-7a2b1123963812025-07-08
68788-8873-2EA - Each68788-8873b9a87529-5007-484c-a960-b284b5c709a512025-07-08
68788-8873-3EA - Each68788-88734bddc350-7378-43bb-ad4e-60865053793a12025-07-08
68788-8873-5EA - Each68788-8873a94c0b78-1fff-486b-bd3c-3d09d2e3866512025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8873EXTRA STRENGTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 4 package rows20250521_95f4b628-6d35-4f6b-91f9-b2d117f8e821.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN95f4b628-6d35-4f6b-91f9-b2d117f8e8211
198440acetaminophen 500 MG Oral TabletSCD95f4b628-6d35-4f6b-91f9-b2d117f8e8211
198440APAP 500 MG Oral TabletSY95f4b628-6d35-4f6b-91f9-b2d117f8e8211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8873-168788887301100 TABLET in 1 BOTTLE (68788-8873-1) 100 tablet2025-05-16NoNoHistorical
68788-8873-26878888730220 TABLET in 1 BOTTLE (68788-8873-2) 20 tablet2025-05-16NoNoHistorical
68788-8873-36878888730330 TABLET in 1 BOTTLE (68788-8873-3) 30 tablet2025-05-16NoNoHistorical
68788-8873-56878888730550 TABLET in 1 BOTTLE (68788-8873-5) 50 tablet2025-05-16NoNoHistorical