FDA.reportPublic FDA data

Extra Strength Pain Relief

Product NDC
68788-8786
11-digit product format
687888786
Labeler code
68788
Product ID
68788-8786_5ef18daa-ac7f-42af-9cbb-fec8469f2161
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
2024-12-12
Marketing end
2026-11-28
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Extra Strength Pain Relief

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
68788-8786-1Extra Strength Pain Relief100 in 1 BOTTLETABLET1002
68788-8786-2Extra Strength Pain Relief20 in 1 BOTTLETABLET202
68788-8786-3Extra Strength Pain Relief30 in 1 BOTTLETABLET302
68788-8786-5Extra Strength Pain Relief50 in 1 BOTTLETABLET502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8786-1EA - Each68788-8786332da0f1-d7a3-4d17-b2eb-f780b0f7cbe912025-02-10
68788-8786-2EA - Each68788-878658b9f442-0185-4a90-8e64-b3d2a0781b1b12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8786EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 4 package rows20241215_c70e3b8e-071d-4b9a-9393-ad8aa09c6b6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNc70e3b8e-071d-4b9a-9393-ad8aa09c6b6e2
198440acetaminophen 500 MG Oral TabletSCDc70e3b8e-071d-4b9a-9393-ad8aa09c6b6e2
198440APAP 500 MG Oral TabletSYc70e3b8e-071d-4b9a-9393-ad8aa09c6b6e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8786-168788878601100 TABLET in 1 BOTTLE (68788-8786-1) 100 tablet2024-12-122026-11-28NoNoHistorical
68788-8786-26878887860220 TABLET in 1 BOTTLE (68788-8786-2) 20 tablet2024-12-122026-11-28NoNoHistorical
68788-8786-36878887860330 TABLET in 1 BOTTLE (68788-8786-3) 30 tablet2024-12-122026-11-28NoNoHistorical
68788-8786-56878887860550 TABLET in 1 BOTTLE (68788-8786-5) 50 tablet2024-12-122026-11-28NoNoHistorical