FDA.reportPublic FDA data

Tylenol 8HR

Product NDC
50580-309
11-digit product format
505800309
Labeler code
50580
Product ID
50580-309_21e84490-8cad-bf34-e063-6394a90af940
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Kenvue Brands LLC
Application
NDA019872
Marketing category
NDA
Marketing start
2016-01-18
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
Tylenol 8HR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui1148399, 1243440

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-309-01Tylenol 8HR24 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE249
50580-309-01Tylenol 8HR1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE19
50580-309-02Tylenol 8HR100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1009
50580-309-02Tylenol 8HR1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-309-01EA - Each50580-3096c8d01b2-e4a8-49b7-b11d-28080e64afdf12025-10-14
50580-309-02EA - Each50580-309960becfa-f238-4fc4-9eeb-46064611682412017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-309TYLENOL 8HR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [KENVUE BRANDS LLC]9Current NDC, Legacy NDC, 4 package rows20241109_5d7d1300-bcb8-466a-880b-310b360ee132.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN5d7d1300-bcb8-466a-880b-310b360ee1329
1243440Tylenol 650 MG 8HR Extended Release Oral TabletPSN5d7d1300-bcb8-466a-880b-310b360ee1329
12434408 HR acetaminophen 650 MG Extended Release Oral Tablet [Tylenol]SBD5d7d1300-bcb8-466a-880b-310b360ee1329
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD5d7d1300-bcb8-466a-880b-310b360ee1329
11483998 HR APAP 650 MG Extended Release Oral TabletSY5d7d1300-bcb8-466a-880b-310b360ee1329
12434408 HR APAP 650 MG Extended Release Oral Tablet [Tylenol]SY5d7d1300-bcb8-466a-880b-310b360ee1329
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY5d7d1300-bcb8-466a-880b-310b360ee1329
1243440Tylenol 650 MG 8 HR Extended Release Oral TabletSY5d7d1300-bcb8-466a-880b-310b360ee1329

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-309-01505800309011 BOTTLE in 1 CARTON (50580-309-01) / 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE1 bottle2016-01-180000-00-00NoNoCurrent
50580-309-02505800309021 BOTTLE in 1 CARTON (50580-309-02) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE1 bottle2016-01-180000-00-00NoNoCurrent