EXTRA STRENGTH ACETAMINOPHEN

Product NDC
49483-697
11-digit product format
494830697
Labeler code
49483
Product ID
49483-697_2dc52443-77b2-5143-e063-6394a90a4958
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
TIME CAP LABORATORIES, INC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-11
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
EXTRA STRENGTH ACETAMINOPHEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui198440

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49483-697-43EXTRA STRENGTH ACETAMINOPHEN400 in 1 BOTTLETABLET4003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-697EXTRA STRENGTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [TIME CAP LABORATORIES, INC.]3Current NDC, Legacy NDC, 1 package rows20250212_c9f80d24-bd05-e1ce-e053-2995a90aa646.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNc9f80d24-bd05-e1ce-e053-2995a90aa6463
198440acetaminophen 500 MG Oral TabletSCDc9f80d24-bd05-e1ce-e053-2995a90aa6463
198440APAP 500 MG Oral TabletSYc9f80d24-bd05-e1ce-e053-2995a90aa6463

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49483-697-4349483069743400 TABLET in 1 BOTTLE (49483-697-43) 400 tablet2022-02-110000-00-00NoNoCurrent