FDA.reportPublic FDA data

CareOne 8 Hour Pain Relief

Product NDC
41520-127
11-digit product format
415200127
Labeler code
41520
Product ID
41520-127_dfce1e9f-caed-464d-a30b-b919ff9e3f4b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
American Sales Company
Application
ANDA075077
Marketing category
ANDA
Marketing start
2017-04-16
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
CareOne 8 Hour 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
41520-127-62CareOne 8 Hour Pain Relief24 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE246
41520-127-62CareOne 8 Hour Pain Relief1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE16
41520-127-71CareOne 8 Hour Pain Relief1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE16
41520-127-71CareOne 8 Hour Pain Relief50 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE506
41520-127-78CareOne 8 Hour Pain Relief100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1006
41520-127-78CareOne 8 Hour Pain Relief1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN9b2b0ef0-7071-4536-8f74-8f1d6250e1056
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD9b2b0ef0-7071-4536-8f74-8f1d6250e1056
11483998 HR APAP 650 MG Extended Release Oral TabletSY9b2b0ef0-7071-4536-8f74-8f1d6250e1056
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY9b2b0ef0-7071-4536-8f74-8f1d6250e1056

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-127-62415200127621 BOTTLE in 1 CARTON (41520-127-62) / 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE1 bottle2025-08-25NoNoHistorical
41520-127-71415200127711 BOTTLE in 1 CARTON (41520-127-71) > 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE1 bottle2017-07-310000-00-00NoNoCurrent
41520-127-78415200127781 BOTTLE in 1 CARTON (41520-127-78) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE1 bottle2017-04-160000-00-00NoNoCurrent