FDA.reportPublic FDA data

Childrens TYLENOL

Product NDC
50580-555
11-digit product format
505800555
Labeler code
50580
Product ID
50580-555_3efe3457-494a-7138-e063-6394a90afc3b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
POWDER
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-15
Substance
ACETAMINOPHEN
Active strength
160 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
Childrens TYLENOL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui2178755, 2178758

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-555-04Childrens TYLENOL30 in 1 CARTONPOWDER309
50580-555-04Childrens TYLENOL1 in 1 PACKETPOWDER19
50580-555-05Childrens TYLENOL1 in 1 PACKETPOWDER19
50580-555-05Childrens TYLENOL18 in 1 CARTONPOWDER189

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-555-04EA - Each50580-555fd75b5c2-e8e9-43ee-bd97-8028c8f0bc8c12021-02-05
50580-555-05EA - Each50580-5558a280b95-1576-4f39-bcfe-5ae9eadb93ff12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-555CHILDRENS TYLENOL (ACETAMINOPHEN) POWDER [KENVUE BRANDS LLC]8Current NDC, Legacy NDC, 4 package rows20241109_79669930-f744-4bb1-8325-b75951489b64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2178755acetaminophen 160 MG Oral PowderPSN79669930-f744-4bb1-8325-b75951489b649
2178758Tylenol 160 MG Oral PowderPSN79669930-f744-4bb1-8325-b75951489b649
2178758acetaminophen 160 MG Oral Powder [Tylenol]SBD79669930-f744-4bb1-8325-b75951489b649
2178755acetaminophen 160 MG Oral PowderSCD79669930-f744-4bb1-8325-b75951489b649
2178755APAP 160 MG Oral PowderSY79669930-f744-4bb1-8325-b75951489b649
2178758APAP 160 MG Oral Powder [Tylenol]SY79669930-f744-4bb1-8325-b75951489b649
2178758Tylenol 160 MG Oral PowderSY79669930-f744-4bb1-8325-b75951489b649

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-555-045058005550430 PACKET in 1 CARTON (50580-555-04) / 1 POWDER in 1 PACKET30 packet2019-07-150000-00-00NoNoCurrent
50580-555-055058005550518 PACKET in 1 CARTON (50580-555-05) / 1 POWDER in 1 PACKET18 packet2019-07-150000-00-00NoNoCurrent