FDA.reportPublic FDA data

Acetaminophen

Product NDC
0363-9798
11-digit product format
003639798
Labeler code
0363
Product ID
0363-9798_465347f3-6acd-a551-e063-6394a90a8729
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
WALGREEN CO.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-24
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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-9798-052023-03-01C16284748780-1f386c649-9bcc-0266-e053-dadaa90a7c1aRapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
0363-9798-242023-03-01C16284748780-1f386c649-9bcc-0266-e053-dadaa90a7c1aRapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
0363-9798-052023-01-30C16284748780-1f386c649-9bcc-0266-e053-dadaa90a7c1aRapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
0363-9798-242023-01-30C16284748780-1f386c649-9bcc-0266-e053-dadaa90a7c1aRapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9798-05Acetaminophen50 in 1 BOTTLETABLET5012
0363-9798-10Acetaminophen100 in 1 BOTTLETABLET10012
0363-9798-15Acetaminophen150 in 1 BOTTLETABLET15012
0363-9798-21Acetaminophen225 in 1 BOTTLETABLET22512
0363-9798-24Acetaminophen24 in 1 BOTTLETABLET2412
0363-9798-37Acetaminophen375 in 1 BOTTLETABLET37512

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9798ACETAMINOPHEN TABLET [WALGREEN CO.]11Current NDC, Legacy NDC, 6 package rows20241220_b375de90-25c7-aa55-e053-2995a90a3cf8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNb375de90-25c7-aa55-e053-2995a90a3cf812
198440acetaminophen 500 MG Oral TabletSCDb375de90-25c7-aa55-e053-2995a90a3cf812
198440APAP 500 MG Oral TabletSYb375de90-25c7-aa55-e053-2995a90a3cf812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9798-050036397980550 TABLET in 1 BOTTLE (0363-9798-05) 50 tablet2021-09-240000-00-00NoNoCurrent
0363-9798-1000363979810100 TABLET in 1 BOTTLE (0363-9798-10) 100 tablet2021-09-240000-00-00NoNoCurrent
0363-9798-1500363979815150 TABLET in 1 BOTTLE (0363-9798-15) 150 tablet2022-09-24NoNoHistorical
0363-9798-2100363979821225 TABLET in 1 BOTTLE (0363-9798-21) 225 tablet2022-07-01NoNoHistorical
0363-9798-240036397982424 TABLET in 1 BOTTLE (0363-9798-24) 24 tablet2021-09-240000-00-00NoNoCurrent
0363-9798-3700363979837375 TABLET in 1 BOTTLE (0363-9798-37) 375 tablet2022-06-25NoNoHistorical