FDA.reportPublic FDA data

Extra Strength Pain Relief

Product NDC
53943-203
11-digit product format
539430203
Labeler code
53943
Product ID
53943-203_d2028e23-24b1-954f-e053-2a95a90a04de
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
DISCOUNT DRUG MART
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-02-24
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53943-203DDiscontinued by firm2026-10-05
excluded packagepackage53943-20353943-203-02DDiscontinued by firm2026-10-05
excluded packagepackage53943-20353943-203-04DDiscontinued by firm2026-10-05

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
53943-203-02Extra Strength Pain Relief1 in 1 CARTONTABLET13
53943-203-02Extra Strength Pain Relief60 in 1 BOTTLE, PLASTICTABLET603
53943-203-04Extra Strength Pain Relief100 in 1 BOTTLE, PLASTICTABLET1003
53943-203-04Extra Strength Pain Relief1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-203EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [DISCOUNT DRUG MART]3Legacy NDC, 4 package rows20241206_b0050f13-dafb-45c6-915d-e7eed30ca18f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNb0050f13-dafb-45c6-915d-e7eed30ca18f3
198440acetaminophen 500 MG Oral TabletSCDb0050f13-dafb-45c6-915d-e7eed30ca18f3
198440APAP 500 MG Oral TabletSYb0050f13-dafb-45c6-915d-e7eed30ca18f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53943-203-02539430203021 BOTTLE, PLASTIC in 1 CARTON (53943-203-02) > 60 TABLET in 1 BOTTLE, PLASTIC2014-02-240000-00-00NoNoCurrent
53943-203-04539430203041 BOTTLE, PLASTIC in 1 CARTON (53943-203-04) > 100 TABLET in 1 BOTTLE, PLASTIC2014-02-240000-00-00NoNoCurrent