FDA.reportPublic FDA data

Childrens Tylenol

Product NDC
50580-522
11-digit product format
505800522
Labeler code
50580
Product ID
50580-522_4f9105c9-c419-3cf0-e063-6394a90ad430
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-02-27
Substance
ACETAMINOPHEN
Active strength
160 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313820Internal 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
9782fe86-d72a-4231-b1ba-d3f3b4ee49e3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-522-24Childrens Tylenol24 in 1 BOTTLETABLET, CHEWABLE24160 mg11
50580-522-24Childrens Tylenol1 in 1 CARTONTABLET, CHEWABLE160 mg11
50580-522-24Childrens Tylenol24 in 1 BOTTLETABLET, CHEWABLE2411
50580-522-24Childrens Tylenol1 in 1 CARTONTABLET, CHEWABLE111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-522-24EA - Each50580-522a99a0921-a62e-4e36-aeb5-b56dbc87f6ca12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-522CHILDRENS TYLENOL (ACETAMINOPHEN) KIT [KENVUE BRANDS LLC]11Current NDC, Legacy NDC20241109_babcb210-6a47-46ef-b4ea-bdde80411cd3.zip
50580-522CHILDRENS TYLENOL (ACETAMINOPHEN) TABLET, CHEWABLE [KENVUE BRANDS LLC]10Current NDC, Legacy NDC, 2 package rows20241103_9782fe86-d72a-4231-b1ba-d3f3b4ee49e3.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 47 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GOOD REMEDIES Extra Strength Pain Relief PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.2d642d8e-c154-a970-e063-6294a90a03bf2025-03-14WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART97f78c4a-9d0d-4fe1-8b2b-d5f8ab939ac42025-03-07WarningsExact identifier
application number: M013
Redicare Non-Aspirin 500mgREDICARE NON-ASPIRIN, ACETAMINOPHEN 500MGRedicare LLC2f229898-1777-732c-e063-6394a90a76bc2025-03-04Warnings, Adverse reactionsExact identifier
application number: M013
Major Extra Strength Acetaminophen LiquidACETAMINOPHENMajor Pharmaceuticals2f3af4dd-45d5-87b4-e063-6294a90ab3cc2025-02-28WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINNCS HealthCare of KY, LLC dba Vangard Labsed9a71d6-a56e-416a-bb89-6d41307efc5a2025-02-27WarningsExact identifier
application number: M013
AspirinASPIRINPD-Rx Pharmaceuticals, Inc.77429b7f-78e4-42c0-8679-ae8da17488482025-02-26WarningsExact identifier
application number: M013
AeroTab Non-AspirinACETAMINOPHEN 500MG ESAero Healthcarefaa3a4ef-3c70-06ca-e053-6394a90a512d2025-02-26WarningsExact identifier
application number: M013
Bufferin Regular Strength Pain ReliefASPIRINGenomma Lab USA3543b2bf-1062-468a-a5dc-eabb2408af8c2025-02-25WarningsExact identifier
application number: M013
Calmour Childrens Acetaminophen Strips ChewableACETAMINOPHEN ORAL CHEWABLE 80 MGCalmourae47b027-4f29-45bb-a8bd-8129789328352025-02-22WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLCf9de7c2f-016b-4f40-8b5e-141ad194be972025-02-20WarningsExact identifier
application number: M013
Genexa Acetaminophen PM Extra StrengthACETAMINOPHENGenexa Inc.d82cf6f3-a291-ca2b-e053-2a95a90a6de12025-02-20WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENAdvagen Pharma Limited8b9456c9-a56b-4748-adb8-c66d6bf072e82025-02-19WarningsExact identifier
application number: M013
Genexa Childrens AcetaminophenACETAMINOPHENGenexa Inc.d89fd9d8-d88e-3968-e053-2a95a90afc5f2025-02-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.debfa787-7a48-48b5-94b0-6128205240322025-02-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.b16e5dcf-b290-4ff2-a150-4b875647ec9a2025-02-19WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCbb6533e5-e6a9-488c-b8ab-a6a06e87ede92025-02-18WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCc830320e-72ba-48ff-a4cd-250ac5650bf02025-02-18WarningsExact identifier
application number: M013
Aspirina CapletsASPIRINBayer HealthCare LLC.2e6f5ba8-8e8b-6059-e063-6394a90adcd52025-02-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPD-Rx Pharmaceuticals, Inc.da7d95af-6583-429d-8d04-e0424f32e9ad2025-02-17WarningsExact identifier
application number: M013
GOODYS Mental AlertASPIRIN AND CAFFEINEMedtech Products Inc.31ef6d07-d314-4d09-abcd-389ba66cbcc52025-02-17WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313820acetaminophen 160 MG Chewable TabletPSNbabcb210-6a47-46ef-b4ea-bdde80411cd311
313820acetaminophen 160 MG Chewable TabletPSN9782fe86-d72a-4231-b1ba-d3f3b4ee49e311
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 TabletPSN9782fe86-d72a-4231-b1ba-d3f3b4ee49e311
828557Tylenol Junior 160 MG Chewable TabletPSNbabcb210-6a47-46ef-b4ea-bdde80411cd311
828557acetaminophen 160 MG Chewable Tablet [Tylenol]SBD9782fe86-d72a-4231-b1ba-d3f3b4ee49e311
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 TabletSCD9782fe86-d72a-4231-b1ba-d3f3b4ee49e311
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 TabletSY9782fe86-d72a-4231-b1ba-d3f3b4ee49e311
313820APAP 160 MG Chewable TabletSYbabcb210-6a47-46ef-b4ea-bdde80411cd311
828557APAP 160 MG Chewable Tablet [Tylenol]SYbabcb210-6a47-46ef-b4ea-bdde80411cd311
828557APAP 160 MG Chewable Tablet [Tylenol]SY9782fe86-d72a-4231-b1ba-d3f3b4ee49e311
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
828557Tylenol 160 MG Chewable TabletSY9782fe86-d72a-4231-b1ba-d3f3b4ee49e311
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
50580-522-24505800522241 BOTTLE in 1 CARTON (50580-522-24) / 24 TABLET, CHEWABLE in 1 BOTTLE1 bottle2017-02-270000-00-00NoNoCurrent