FDA.reportPublic FDA data

Extra Strength Pain Relief

Product NDC
53943-203
11-digit product format
539430203
Labeler code
53943
Product ID
53943-203_287301d8-a2bf-02d4-e063-6394a90a89c3
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
DISCOUNT DRUG MART
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-02-24
Marketing end
2026-07-31
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
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]3Current NDC, Legacy 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, PLASTIC2014-02-242026-05-31NoNoCurrent
53943-203-04539430203041 BOTTLE, PLASTIC in 1 CARTON (53943-203-04) / 100 TABLET in 1 BOTTLE, PLASTIC2014-02-242026-07-31NoNoCurrent