FDA.reportPublic FDA data

8 hr Arthritis Pain Relief

Product NDC
55910-892
11-digit product format
559100892
Labeler code
55910
Product ID
55910-892_f9c20045-2698-d9b2-e053-6294a90a2b11
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
DOLGENCORP, INC.
Application
ANDA215486
Marketing category
ANDA
Marketing start
2023-04-29
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
8 hr Arthritis 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
55910-892-058 hr Arthritis Pain Relief1 in 1 CARTONTABLET, EXTENDED RELEASE12
55910-892-058 hr Arthritis Pain Relief50 in 1 BOTTLETABLET, EXTENDED RELEASE502
55910-892-268 hr Arthritis Pain Relief225 in 1 BOTTLETABLET, EXTENDED RELEASE2252
55910-892-268 hr Arthritis Pain Relief1 in 1 CARTONTABLET, EXTENDED RELEASE12
55910-892-428 hr Arthritis Pain Relief24 in 1 BOTTLETABLET, EXTENDED RELEASE242
55910-892-428 hr Arthritis Pain Relief1 in 1 CARTONTABLET, EXTENDED RELEASE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-8928 HR ARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [DOLGENCORP, INC.]2Current NDC, 6 package rows20230429_ea2eae7c-e9bd-534c-e053-2a95a90a26c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNea2eae7c-e9bd-534c-e053-2a95a90a26c82
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDea2eae7c-e9bd-534c-e053-2a95a90a26c82
11483998 HR APAP 650 MG Extended Release Oral TabletSYea2eae7c-e9bd-534c-e053-2a95a90a26c82
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYea2eae7c-e9bd-534c-e053-2a95a90a26c82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55910-892-05559100892051 BOTTLE in 1 CARTON (55910-892-05) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2023-04-29NoNoCurrent
55910-892-26559100892261 BOTTLE in 1 CARTON (55910-892-26) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2023-04-29NoNoCurrent
55910-892-42559100892421 BOTTLE in 1 CARTON (55910-892-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2023-04-29NoNoCurrent