FDA.reportPublic FDA data

Childrens Tylenol

Product NDC
50580-460
11-digit product format
505800460
Labeler code
50580
Product ID
50580-460_25b04cc9-cc56-5d5c-e063-6394a90a0eee
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen
Dosage form
KIT
Labeler
Kenvue Brands LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-05-07
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Tylenol
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
307668Internal RxNorm lookup
313820Internal RxNorm lookup
828555Internal RxNorm lookup
828557Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
babcb210-6a47-46ef-b4ea-bdde80411cd3Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50580-460-012024-02-06C16284748780-11030e365-1070-111a-e063-dadaa90a10e2Children's Tylenol
50580-460-012024-01-30C16284748780-11030e365-1070-111a-e063-dadaa90a10e2Children's Tylenol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-460-01Childrens Tylenol1 in 1 PACKAGEKIT111
50580-522-24Childrens Tylenol24 in 1 BOTTLETABLET, CHEWABLE24160 mg11
50580-522-24Childrens Tylenol1 in 1 CARTONTABLET, CHEWABLE160 mg11
50580-612-01Childrens Tylenol120 mL in 1 BOTTLESUSPENSION120 mL160 mg in 5mL11
50580-612-01Childrens Tylenol1 in 1 CARTONSUSPENSION160 mg in 5mL11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-460-01EA - Each50580-46044ba42a1-c723-4e98-8e1c-014564bc34a812018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-460CHILDRENS TYLENOL (ACETAMINOPHEN) KIT [KENVUE BRANDS LLC]11Current NDC, Legacy NDC, 5 package rows20241109_babcb210-6a47-46ef-b4ea-bdde80411cd3.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 8 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AspirinASPIRINUnited Natural Foods, Inc. dba UNFI19c7f832-d7ec-4dcc-8aa4-f4cbf64c9ff62026-07-02WarningsExact identifier
application number: M013
pain relief EXTRA STRENGTHACETAMINOPHENMeijer Distribution, Inc.ae84eb7e-a70b-4311-b2dc-ad153047a5162026-07-01WarningsExact identifier
application number: M013
Aspirin 325 mgASPIRINHi-Tech Nutraceuticals, LLCb3426a9a-ea99-da30-e053-2995a90a1e4b2026-07-01WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINESalado Sales, Inc.ca21d576-be3c-495d-9dbd-ed514bf65da72026-07-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMeijer Distribution Inc4e08a7cb-3894-84c3-e063-6394a90a0b422026-06-30WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEWal-Mart Stores Inc9b1201af-c802-4e19-b192-bbbf34367db42026-06-30WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENP & L Development, LLCfc841cba-8f4f-407b-97de-0422977515bd2026-06-30WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEUnited Natural Foods, Inc. dba UNFIb6ff2b34-51ee-41bc-8b7d-7520ade0bf362026-06-30WarningsExact identifier
application number: M013
MedlineASPIRINMedline Industries, LP4b0c569a-ed7a-e104-e063-6394a90a6d542026-06-29WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWALMART INC.e50b3f60-b827-426c-8e78-8447c89130fe2026-06-29WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINE HCLChain Drug Marketing Association, Inc.e58417f4-3575-4433-ac2e-b7bf9fe8ba102026-06-29WarningsExact identifier
application number: M013
Dr Kids Pain and FeverACETAMINOPHENCalmCo LLC5534a784-a7b1-5599-e063-6294a90a79612026-06-27WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENSelect Consumer Group LLC529d3a51-a248-7c02-e063-6294a90a10ae2026-06-27WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSportpharm LLC830ffcaa-7ff8-4732-bc84-6a8c5e78722d2026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINStrategic Sourcing Services LLCea2ef485-429e-4c63-ba7b-0a6b32892ad22026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINChain Drug Marketing Association, Inc.055d8420-c189-4a9e-acdc-21627935c8eb2026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINTopco Associates, LLC5f32cf74-dbea-496c-ba23-2040ea354f402026-06-25WarningsExact identifier
application number: M013
AspirinASPIRINSalado Sales, Inc.cf3139a5-e36e-48e3-bb6c-e102b0cec5552026-06-25WarningsExact identifier
application number: M013
Pain Relief AspirinASPIRINRite Aid Corporationbd69d3d2-5d38-47c6-98a6-124f7a43b8b02026-06-25WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINWalgreen Company0b27c0fd-7ea8-4588-9169-5ad4e8df77ef2026-06-25WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313820acetaminophen 160 MG Chewable TabletPSNbabcb210-6a47-46ef-b4ea-bdde80411cd311
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNbabcb210-6a47-46ef-b4ea-bdde80411cd311
828555Tylenol 160 MG in 5 mL Oral SuspensionPSNbabcb210-6a47-46ef-b4ea-bdde80411cd311
828557Tylenol Junior 160 MG Chewable TabletPSNbabcb210-6a47-46ef-b4ea-bdde80411cd311
828557acetaminophen 160 MG Chewable Tablet [Tylenol]SBDbabcb210-6a47-46ef-b4ea-bdde80411cd311
828555acetaminophen 32 MG/ML Oral Suspension [Tylenol]SBDbabcb210-6a47-46ef-b4ea-bdde80411cd311
313820acetaminophen 160 MG Chewable TabletSCDbabcb210-6a47-46ef-b4ea-bdde80411cd311
307668acetaminophen 32 MG/ML Oral SuspensionSCDbabcb210-6a47-46ef-b4ea-bdde80411cd311
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYbabcb210-6a47-46ef-b4ea-bdde80411cd311
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYbabcb210-6a47-46ef-b4ea-bdde80411cd311
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYbabcb210-6a47-46ef-b4ea-bdde80411cd311
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYbabcb210-6a47-46ef-b4ea-bdde80411cd311
313820APAP 160 MG Chewable TabletSYbabcb210-6a47-46ef-b4ea-bdde80411cd311
828557APAP 160 MG Chewable Tablet [Tylenol]SYbabcb210-6a47-46ef-b4ea-bdde80411cd311
307668APAP 32 MG/ML Oral SuspensionSYbabcb210-6a47-46ef-b4ea-bdde80411cd311
828555APAP 32 MG/ML Oral Suspension [Tylenol]SYbabcb210-6a47-46ef-b4ea-bdde80411cd311
828557Tylenol 160 MG Chewable TabletSYbabcb210-6a47-46ef-b4ea-bdde80411cd311
828555Tylenol 160 MG per 5 ML Oral SuspensionSYbabcb210-6a47-46ef-b4ea-bdde80411cd311
828555Tylenol 32 MG/ML Oral SuspensionSYbabcb210-6a47-46ef-b4ea-bdde80411cd311
828555Tylenol Infants 160 MG in 5 mL Oral SuspensionSYbabcb210-6a47-46ef-b4ea-bdde80411cd311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-460-01505800460011 KIT in 1 PACKAGE (50580-460-01) * 1 BOTTLE in 1 CARTON (50580-522-24) / 24 TABLET, CHEWABLE in 1 BOTTLE * 1 BOTTLE in 1 CARTON (50580-612-01) / 120 mL in 1 BOTTLE1 kit2018-05-070000-00-00NoNoCurrent
50580-522-245058005222424 in 1 BOTTLEHistorical
50580-612-0150580061201120 mL in 1 BOTTLE120 mlHistorical