8 hr Pain Relief

Product NDC
55910-895
11-digit product format
559100895
Labeler code
55910
Product ID
55910-895_f9c35f34-c494-2573-e053-6294a90aee3a
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
362O9ITL9DACETAMINOPHEN103-90-2ACETAMINOPHEN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55910-895-05559100895051 BOTTLE in 1 BOTTLE (55910-895-05) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2023-04-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
704R 55910-895 Dollar General Acetaminophen Extended-Release Tablets 650 mg - Muscle Aches & PainDOLGENCORP, INC. | TIME CAP LABORATORIES, INC. | Marksans Pharma Ltd2023-04-20HUMAN OTC DRUG LABEL2