Pain Relief

Product NDC
69168-461
11-digit product format
691680461
Labeler code
69168
Product ID
69168-461_597ef1fc-5ca5-4a06-958c-e2ddc6b6de84
Type
HUMAN OTC DRUG
Nonproprietary name
Pain Relief
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Allegiant Health
Application
ANDA211544
Marketing category
ANDA
Marketing start
2024-04-24
Substance
ACETAMINOPHEN
Active strength
650 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui1148399

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-461-03Pain Relief250 in 1 BOTTLETABLET, EXTENDED RELEASE2503
69168-461-17Pain Relief300 in 1 BOTTLETABLET, EXTENDED RELEASE3003
69168-461-32Pain Relief100 in 1 BOTTLETABLET, EXTENDED RELEASE1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-461PAIN RELIEF TABLET, EXTENDED RELEASE [ALLEGIANT HEALTH]3Current NDC, 3 package rows20241121_f4720346-c3e0-4707-b007-1bf1f5e05707.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNf4720346-c3e0-4707-b007-1bf1f5e057073
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDf4720346-c3e0-4707-b007-1bf1f5e057073
11483998 HR APAP 650 MG Extended Release Oral TabletSYf4720346-c3e0-4707-b007-1bf1f5e057073
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYf4720346-c3e0-4707-b007-1bf1f5e057073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69168-461-0369168046103250 TABLET, EXTENDED RELEASE in 1 BOTTLE (69168-461-03) 2024-05-24NoNoCurrent
69168-461-1769168046117300 TABLET, EXTENDED RELEASE in 1 BOTTLE (69168-461-17) 2024-11-18NoNoCurrent
69168-461-3269168046132100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69168-461-32) 2024-05-24NoNoCurrent