FDA.reportPublic FDA data

Pain Relief

Product NDC
83324-081
11-digit product format
833240081
Labeler code
83324
Product ID
83324-081_1ac6e721-4d0a-0396-e063-6294a90a7fe9
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Chain Drug Marketing Association
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-26
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pain Relief
Brand name suffix
Extra Strength
Listing expiration
2026-12-31

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
83324-081-01Pain ReliefExtra Strength100 in 1 PACKAGETABLET1002
83324-081-01Pain ReliefExtra Strength1 in 1 CARTONTABLET12
83324-081-10Pain ReliefExtra Strength100 in 1 BOTTLE, PLASTICTABLET1002
83324-081-60Pain ReliefExtra Strength60 in 1 BOTTLE, PLASTICTABLET602
83324-081-60Pain ReliefExtra Strength1 in 1 CARTONTABLET12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-081-01EA - Each83324-081e54beb91-3e2c-4ee4-93be-0ea7ee0c454a12026-01-08
83324-081-10EA - Each83324-0812b7a8e0d-06af-48b6-9c17-b2bd7bccc12112026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-081PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]2Current NDC, 5 package rows20240615_cfaf9495-e654-4dfc-ba23-d2358c3720c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNcfaf9495-e654-4dfc-ba23-d2358c3720c42
198440acetaminophen 500 MG Oral TabletSCDcfaf9495-e654-4dfc-ba23-d2358c3720c42
198440APAP 500 MG Oral TabletSYcfaf9495-e654-4dfc-ba23-d2358c3720c42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-081-01833240081011 PACKAGE in 1 CARTON (83324-081-01) / 100 TABLET in 1 PACKAGE1 package2024-04-26NoNoHistorical
83324-081-1083324008110100 TABLET in 1 BOTTLE, PLASTIC (83324-081-10) 100 tablet2024-06-12NoNoHistorical
83324-081-60833240081601 BOTTLE, PLASTIC in 1 CARTON (83324-081-60) / 60 TABLET in 1 BOTTLE, PLASTIC2024-04-26NoNoHistorical