FDA.reportPublic FDA data

Childrens TYLENOL

Product NDC
50580-579
11-digit product format
505800579
Labeler code
50580
Product ID
50580-579_22d91a96-0b05-5f31-e063-6394a90aae0b
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
2017-01-16
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
ce0a1fbc-7345-462b-b0da-c7149bdc288cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-579-02Childrens TYLENOL120 mL in 1 BOTTLESUSPENSION1207
50580-579-02Childrens TYLENOL1 in 1 CARTONSUSPENSION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-579-02ML - Milliliter50580-57931853ac6-b4eb-4c47-9c00-72ca0289847b12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-579CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [KENVUE BRANDS LLC]7Current NDC, Legacy NDC, 2 package rows20241109_ce0a1fbc-7345-462b-b0da-c7149bdc288c.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 71 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLC0faa3592-4d56-4645-9a0e-066e0bdfebb62024-04-05WarningsExact identifier
application number: M013
Pain Relief Childrens Dye FreeACETAMINOPHENH E B3f9beeeb-5e27-4b81-a647-20e65f0e9fc92024-04-03WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINH E Bedb321dd-e5cb-4031-a8a8-efce9e86fe162024-04-03WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENH E Ba0c0277e-50aa-4328-8f93-ab20c6176b2b2024-04-03WarningsExact identifier
application number: M013
Regular Strength Enteric coated aspirinASPIRINBryant Ranch Prepackbda805ab-7f37-405d-a144-4e06ad9a29a12024-04-03WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEFamily Dollar (FAMILY WELLNESS)650cb15e-c448-4df3-b0f8-4398be05d8412024-03-27WarningsExact identifier
application number: M013
Good Sense Effervescent Pain ReliefASPIRINPerrigo Direct, Inc.103027a7-2f0e-8d8c-e063-6294a90aedc72024-03-26WarningsExact identifier
application number: M013
rugby infants acetaminophenACETAMINOPHENRugby Laboratories8aa9ac68-ca61-4163-a876-52034138c1ea2024-03-25WarningsExact identifier
application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mgACETAMINOPHENWalmart Inc08a18481-f029-f01f-e063-6294a90aac652024-03-21WarningsExact identifier
application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mgACETAMINOPHENWalmart Inc0d106fa2-2a77-deb2-e063-6394a90a2dac2024-03-21WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)872c5220-a379-4dc1-b99c-f11ebb82db352024-03-19WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)79886972-47a4-44c5-a131-1a691a3281032024-03-19WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)5ffcc78d-9163-4cb4-8811-ae9f0142806a2024-03-18WarningsExact identifier
application number: M013
ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVERASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVERHF Acquisition Co LLC, DBA HealthFirst13e621dc-b2b4-98fd-e063-6394a90acc752024-03-17WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS PHARMACY, INC097a9c98-a092-400d-9600-6797b0b9a50c2024-03-15WarningsExact identifier
application number: M013
Excedrin PM Triple Action Caplets and Excedrin Tension HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATEHaleon US Holdings LLC978a9d27-6d41-42cb-a193-11314923d2ac2024-03-14WarningsExact identifier
application number: M013
Excedrin PM Triple Action CapletsACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATEHaleon US Holdings LLCb3812d27-40af-40d7-864a-dfa4ae34cb9e2024-03-14WarningsExact identifier
application number: M013
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLC691b754c-bafc-47e2-a322-cf56245c01f62024-03-14WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS PHARMACY, INCfdc80b2a-d7c1-4b3d-9a9b-28182c6320de2024-03-14WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENQUALITY CHOICE (Chain Drug Marketing Association)2cde052d-22a4-470f-8d6a-7c17061b8ac82024-03-14WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNce0a1fbc-7345-462b-b0da-c7149bdc288c7
828555Tylenol 160 MG in 5 mL Oral SuspensionPSNce0a1fbc-7345-462b-b0da-c7149bdc288c7
828555acetaminophen 32 MG/ML Oral Suspension [Tylenol]SBDce0a1fbc-7345-462b-b0da-c7149bdc288c7
307668acetaminophen 32 MG/ML Oral SuspensionSCDce0a1fbc-7345-462b-b0da-c7149bdc288c7
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYce0a1fbc-7345-462b-b0da-c7149bdc288c7
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYce0a1fbc-7345-462b-b0da-c7149bdc288c7
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYce0a1fbc-7345-462b-b0da-c7149bdc288c7
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYce0a1fbc-7345-462b-b0da-c7149bdc288c7
307668APAP 32 MG/ML Oral SuspensionSYce0a1fbc-7345-462b-b0da-c7149bdc288c7
828555APAP 32 MG/ML Oral Suspension [Tylenol]SYce0a1fbc-7345-462b-b0da-c7149bdc288c7
828555Tylenol 160 MG per 5 ML Oral SuspensionSYce0a1fbc-7345-462b-b0da-c7149bdc288c7
828555Tylenol 32 MG/ML Oral SuspensionSYce0a1fbc-7345-462b-b0da-c7149bdc288c7
828555Tylenol Infants 160 MG in 5 mL Oral SuspensionSYce0a1fbc-7345-462b-b0da-c7149bdc288c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-579-02505800579021 BOTTLE in 1 CARTON (50580-579-02) / 120 mL in 1 BOTTLE1 bottle2017-01-160000-00-00NoNoCurrent