Acetaminophen Extra Strength

Product NDC
55319-053
11-digit product format
553190053
Labeler code
55319
Product ID
55319-053_0bd0c0ce-b9a6-c10e-e063-6394a90a3c77
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Family Dollar Stores, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-11
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
Acetaminophen Extra Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui198440

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-053-14Acetaminophen Extra Strength50 in 1 BOTTLETABLET503
55319-053-14Acetaminophen Extra Strength1 in 1 CARTONTABLET13
55319-053-21Acetaminophen Extra Strength100 in 1 BOTTLETABLET1003
55319-053-21Acetaminophen Extra Strength1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-053ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [FAMILY DOLLAR STORES, LLC]3Current NDC, 4 package rows20231207_f86dcbb8-debc-4bce-e053-6294a90a7a02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNf86dcbb8-debc-4bce-e053-6294a90a7a023
198440acetaminophen 500 MG Oral TabletSCDf86dcbb8-debc-4bce-e053-6294a90a7a023
198440APAP 500 MG Oral TabletSYf86dcbb8-debc-4bce-e053-6294a90a7a023

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-053-14553190053141 BOTTLE in 1 CARTON (55319-053-14) / 50 TABLET in 1 BOTTLE1 bottle2023-08-11NoNoHistorical
55319-053-21553190053211 BOTTLE in 1 CARTON (55319-053-21) / 100 TABLET in 1 BOTTLE1 bottle2023-08-11NoNoHistorical