FDA.reportPublic FDA data

EXTRA STRENGTH PAIN RELEIF

Product NDC
68210-4204
11-digit product format
682104204
Labeler code
68210
Product ID
68210-4204_ee9f1a77-7941-445d-e053-2a95a90a34e5
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
SPIRIT PHARMACEUTICALS LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-04-28
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
500 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68210-4204IInactivated by FDA2026-10-15
excluded packagepackage68210-420468210-4204-4IInactivated by FDA2026-10-15

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68210-4204-42026-01-29C16284748780-149896155-a5b2-586f-e063-e6dba90add90EXTRA STRENGTH PAIN RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4204-4EXTRA STRENGTH PAIN RELEIF1 in 1 CARTONTABLET, FILM COATED15
68210-4204-4EXTRA STRENGTH PAIN RELEIF40 in 1 BOTTLETABLET, FILM COATED405

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4204EXTRA STRENGTH PAIN RELEIF (ACETAMINOPHEN) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC]5Legacy NDC, 2 package rows20241215_eda9e18e-418f-4640-a111-7c2cdd7a5703.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNeda9e18e-418f-4640-a111-7c2cdd7a57035
198440acetaminophen 500 MG Oral TabletSCDeda9e18e-418f-4640-a111-7c2cdd7a57035
198440APAP 500 MG Oral TabletSYeda9e18e-418f-4640-a111-7c2cdd7a57035

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-4204-4682104204041 BOTTLE in 1 CARTON (68210-4204-4) > 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-07-180000-00-00NoNoCurrent