FDA.reportPublic FDA data

Regular Strength Pain Relief

Product NDC
68788-7359
11-digit product format
687887359
Labeler code
68788
Product ID
68788-7359_35613095-da8f-4e07-98ca-8e2b95c856eb
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-08-21
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
325 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-7359DDiscontinued by firm2026-10-16
excluded packagepackage68788-735968788-7359-1DDiscontinued by firm2026-10-16
excluded packagepackage68788-735968788-7359-3DDiscontinued by firm2026-10-16
excluded packagepackage68788-735968788-7359-6DDiscontinued by firm2026-10-16
excluded packagepackage68788-735968788-7359-9DDiscontinued by firm2026-10-16

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7359REGULAR STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [PREFERRED PHARMACEUTICALS INC.]7Legacy NDC20241229_f5758d39-7f9d-4092-a8ae-aa28a0439d39.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7359-168788735901100 TABLET in 1 BOTTLE (68788-7359-1) 100 tablet2019-08-210000-00-00NoNoCurrent
68788-7359-36878873590330 TABLET in 1 BOTTLE (68788-7359-3) 30 tablet2019-08-210000-00-00NoNoCurrent
68788-7359-66878873590660 TABLET in 1 BOTTLE (68788-7359-6) 60 tablet2019-08-210000-00-00NoNoCurrent
68788-7359-96878873590990 TABLET in 1 BOTTLE (68788-7359-9) 90 tablet2019-08-210000-00-00NoNoCurrent