FDA.reportPublic FDA data

EXTRA STRENGTH PAIN RELEIF

Product NDC
68210-4144
Requested package NDC
68210-4144-4
11-digit product format
682104144
Labeler code
68210
Product ID
68210-4144_ee8efe74-df7a-41b8-e053-2a95a90ac2bc
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68210-414468210-4144-4IInactivated by FDA2026-10-16

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4144-4EXTRA STRENGTH PAIN RELEIF40 in 1 BOTTLETABLET, FILM COATED405
68210-4144-4EXTRA STRENGTH PAIN RELEIF1 in 1 CARTONTABLET, FILM COATED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4144EXTRA STRENGTH PAIN RELEIF (ACETAMINOPHEN) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC]5Legacy NDC, 2 package rows20241215_c235ed42-81f6-4373-b15d-8a0c8e60e883.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNc235ed42-81f6-4373-b15d-8a0c8e60e8835
198440acetaminophen 500 MG Oral TabletSCDc235ed42-81f6-4373-b15d-8a0c8e60e8835
198440APAP 500 MG Oral TabletSYc235ed42-81f6-4373-b15d-8a0c8e60e8835

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-4144-4682104144041 BOTTLE in 1 CARTON (68210-4144-4) > 40 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-04-280000-00-00NoNoCurrent