FDA.reportPublic FDA data

Pain Relief

Product NDC
83324-078
11-digit product format
833240078
Labeler code
83324
Product ID
83324-078_458b4f7d-8f0c-2559-e063-6294a90a663b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION, INC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-03
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
83324-078-01Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED13
83324-078-01Pain ReliefExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED1003
83324-078-05Pain ReliefExtra Strength500 in 1 BOTTLE, PLASTICTABLET, COATED5003
83324-078-15Pain ReliefExtra Strength150 in 1 BOTTLE, PLASTICTABLET, COATED1503
83324-078-24Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED13
83324-078-24Pain ReliefExtra Strength24 in 1 BOTTLE, PLASTICTABLET, COATED243
83324-078-50Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED13
83324-078-50Pain ReliefExtra Strength50 in 1 BOTTLE, PLASTICTABLET, COATED503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-078-01EA - Each83324-0788ba5a904-64d3-4327-93d3-7e433d1e33c212026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-078PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION, INC.]2Current NDC, 8 package rows20240615_c57c10fc-f182-4153-8974-ef359a5f5ac1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNc57c10fc-f182-4153-8974-ef359a5f5ac13
198440acetaminophen 500 MG Oral TabletSCDc57c10fc-f182-4153-8974-ef359a5f5ac13
198440APAP 500 MG Oral TabletSYc57c10fc-f182-4153-8974-ef359a5f5ac13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83324-078-01833240078011 BOTTLE, PLASTIC in 1 CARTON (83324-078-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2024-04-03NoNoHistorical
83324-078-0583324007805500 TABLET, COATED in 1 BOTTLE, PLASTIC (83324-078-05) 2024-04-03NoNoHistorical
83324-078-1583324007815150 TABLET, COATED in 1 BOTTLE, PLASTIC (83324-078-15) 2024-04-03NoNoHistorical
83324-078-24833240078241 BOTTLE, PLASTIC in 1 CARTON (83324-078-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2024-04-03NoNoHistorical
83324-078-50833240078501 BOTTLE, PLASTIC in 1 CARTON (83324-078-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2024-04-03NoNoHistorical