FDA.reportPublic FDA data

Childrens TYLENOL

Product NDC
50580-612
11-digit product format
505800612
Labeler code
50580
Product ID
50580-612_22ef278e-cdce-0cd3-e063-6394a90af8ea
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-08-01
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

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
307668Internal RxNorm lookup
828555Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d8aa3b1a-5f63-49db-998c-35cd11bd733fAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50580-612-012024-02-06Children's TYLENOL ®
50580-612-022024-02-06Children's TYLENOL ®
50580-612-012024-01-30Children's TYLENOL ®
50580-612-022024-01-30Children's TYLENOL ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-612-01Childrens TYLENOL1 in 1 CARTONSUSPENSION112
50580-612-01Childrens TYLENOL120 mL in 1 BOTTLESUSPENSION12012
50580-612-02Childrens TYLENOL1 in 1 CARTONSUSPENSION112
50580-612-02Childrens TYLENOL2 in 1 PACKAGESUSPENSION212
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
50580-612-01ML - Milliliter50580-61205be4ab3-3116-4f04-9f29-23a4e16cf98a12017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-612CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [KENVUE BRANDS LLC]12Current NDC, Legacy NDC, 4 package rows20241103_d8aa3b1a-5f63-49db-998c-35cd11bd733f.zip
50580-612CHILDRENS TYLENOL (ACETAMINOPHEN) KIT [KENVUE BRANDS LLC]11Current NDC, Legacy NDC20241109_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 79 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief PM Extra StrengthACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MGAllegiant Health423a8445-964c-4cdb-889a-f391ca5253e72018-12-31WarningsExact identifier
application number: M013
Cold Multi-Symptom Night-timeACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCIAllegiant Health3f020cf2-6011-4216-9b39-0b3dc5f0749c2018-12-26WarningsExact identifier
application number: M013
Aspirin ChewableASPIRIN 81 MGAllegiant Health92b8637b-03a9-461f-b2f6-6eddaa2149532018-12-21WarningsExact identifier
application number: M013
Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-DrowsyACETAMINOPHEN AND PHENYLEPHRINE HCLAllegiant Healthb04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f2018-12-21WarningsExact identifier
application number: M013
Clear Choice Regular Strength Pain RelieverACETAMINOPHENAthlete's Needs, Inc.d0d9fda5-5eba-4d51-b505-e93a2ae0bdd72018-12-11WarningsExact identifier
application number: M013
ASPIRIN Enteric CoatedASPIRIN 81 MGAllegiant Health5910a882-eb40-440f-8a30-c21fbce9050e2018-11-07WarningsExact identifier
application number: M013
AspirinASPIRIN 325 MGAllegiant Health88b54062-8b3d-4024-a957-62b3255184b92018-11-07WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRIN 81 MGAllegiant Health3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe52018-11-07WarningsExact identifier
application number: M013
Tension Headache ReliefTENSION HEADACHE RELIEFAllegiant Healthb431a1a3-39c4-4d6c-afdc-c8b017ad89da2017-11-16WarningsExact identifier
application number: M013
SED-MAXACETAMINOPHEN 500 MG WITH CAFFEINE 65MGCommand Brands, LLC4920a0e9-6f88-4df0-8657-77c95a3b96172017-01-19WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNd8aa3b1a-5f63-49db-998c-35cd11bd733f12
828555Tylenol 160 MG in 5 mL Oral SuspensionPSNd8aa3b1a-5f63-49db-998c-35cd11bd733f12
828555acetaminophen 32 MG/ML Oral Suspension [Tylenol]SBDd8aa3b1a-5f63-49db-998c-35cd11bd733f12
307668acetaminophen 32 MG/ML Oral SuspensionSCDd8aa3b1a-5f63-49db-998c-35cd11bd733f12
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYd8aa3b1a-5f63-49db-998c-35cd11bd733f12
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYd8aa3b1a-5f63-49db-998c-35cd11bd733f12
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYd8aa3b1a-5f63-49db-998c-35cd11bd733f12
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYd8aa3b1a-5f63-49db-998c-35cd11bd733f12
307668APAP 32 MG/ML Oral SuspensionSYd8aa3b1a-5f63-49db-998c-35cd11bd733f12
828555APAP 32 MG/ML Oral Suspension [Tylenol]SYd8aa3b1a-5f63-49db-998c-35cd11bd733f12
828555Tylenol 160 MG per 5 ML Oral SuspensionSYd8aa3b1a-5f63-49db-998c-35cd11bd733f12
828555Tylenol 32 MG/ML Oral SuspensionSYd8aa3b1a-5f63-49db-998c-35cd11bd733f12
828555Tylenol Infants 160 MG in 5 mL Oral SuspensionSYd8aa3b1a-5f63-49db-998c-35cd11bd733f12
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
50580-612-01505800612011 BOTTLE in 1 CARTON (50580-612-01) / 120 mL in 1 BOTTLE1 bottle2016-08-010000-00-00NoNoCurrent
50580-612-02505800612022 CARTON in 1 PACKAGE (50580-612-02) / 1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE2 carton2016-10-030000-00-00NoNoCurrent