TYLENOL For Children Plus Adults

Product NDC
50580-177
11-digit product format
505800177
Labeler code
50580
Product ID
50580-177_35a3c165-116d-b171-e063-6394a90a8abd
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
2021-07-01
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
TYLENOL For Children Plus Adults
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
5bb8ef99-a94b-49f9-89f9-cd1ce0a47a42Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-177-08TYLENOL For Children Plus Adults240 mL in 1 BOTTLESUSPENSION2405
50580-177-08TYLENOL For Children Plus Adults1 in 1 CARTONSUSPENSION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-177-08ML - Milliliter50580-177b7b1498c-76fc-4302-87c4-bd0db62d479912021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-177TYLENOL FOR CHILDREN PLUS ADULTS (ACETAMINOPHEN) SUSPENSION [KENVUE BRANDS LLC]5Current NDC, Legacy NDC, 2 package rows20250523_5bb8ef99-a94b-49f9-89f9-cd1ce0a47a42.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 64 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tylenol PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc639f4e01-9723-a619-e053-2991aa0a549a2024-08-27WarningsExact identifier
application number: M013
Extra Strength Acetaminohpen Adult Rapid Burst CherryACETAMINOPHENMajor Pharmaceuticals9e7543d9-6249-45b5-b67d-c1b439423b9c2024-08-27WarningsExact identifier
application number: M013
aspirinASPIRINMajor Pharmaceuticals58684138-04d1-44a4-bc52-c5b85d93d7a62024-08-23WarningsExact identifier
application number: M013
Up and Up childrens acetaminophenACETAMINOPHENTarget Corporation9c3ba4dd-f51b-46ce-91b8-8b617c7b78da2024-08-23WarningsExact identifier
application number: M013
CVS Effervescent Pain RelieverASPIRINCVS PHARMACY0761147f-1337-606e-e063-6394a90abd5d2024-08-22WarningsExact identifier
application number: M013
pain relieverACETAMINOPHENWalgreen Company8255900a-2d58-4261-8df7-f283198835702024-08-21WarningsExact identifier
application number: M013
Pain and FeverACETAMINOPHENH E B86a072a9-c3b8-47f7-8598-d66e3d30e7622024-08-21WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENKroger Companyd965eba0-b268-41b2-8e02-5f6d769a44d72024-08-18WarningsExact identifier
application number: M013
equate pain and fever childrensACETAMINOPHENWal-Mart Stores Incea68d735-c677-4280-a3a3-ae3eb5ff74622024-08-17WarningsExact identifier
application number: M013
childrens pain and feverACETAMINOPHENCVS Pharmacyfac408f0-ebb6-4c72-88ee-2ba85867859c2024-08-16WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENBryant Ranch Prepack3f0c32b1-2c54-4ca3-9759-9e5dd9d7ad242024-08-14WarningsExact identifier
application number: M013
Quality Choice Effervescent Antacid and Pain Relief - Extra StrengthASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association1f926637-a61c-8eb7-e063-6394a90a65022024-08-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma6ec12573-03d6-40c1-9945-d345b401e0622024-08-12WarningsExact identifier
application number: M013
CareOne Infants AcetaminophenACETAMINOPHENAmerican Sales Companyeacee273-abd7-4ea4-bcaa-7f74abcc9feb2024-08-07WarningsExact identifier
application number: M013
infants pain and feverACETAMINOPHENKroger Company7dbe284a-c0d5-4ac4-8445-611610f3c0fb2024-08-02WarningsExact identifier
application number: M013
Dollar General Effervescent Pain RelieverASPIRINDolgencorp, Inc1deab362-a325-3a00-e063-6294a90a9acd2024-08-01WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFSA STORE INC.1cd6a3e6-1376-0b7b-e063-6394a90af3d12024-07-30WarningsExact identifier
application number: M013
pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLPublix Super Markets Inc42d271b7-b45f-4497-8de2-4e05b4bebfa92024-07-17WarningsExact identifier
application number: M013
basic care acetaminophen pmACETAMINOPHEN, DIPHENHYDRAMINE HCLAmazon.com Services LLC64a0084a-e29e-4c1a-8704-13a3e1238f762024-07-17WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINWalmart Inc.152c013a-c81c-f8f9-e063-6294a90a9f232024-07-15WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN5bb8ef99-a94b-49f9-89f9-cd1ce0a47a425
828555Tylenol 160 MG in 5 mL Oral SuspensionPSN5bb8ef99-a94b-49f9-89f9-cd1ce0a47a425
828555acetaminophen 32 MG/ML Oral Suspension [Tylenol]SBD5bb8ef99-a94b-49f9-89f9-cd1ce0a47a425
307668acetaminophen 32 MG/ML Oral SuspensionSCD5bb8ef99-a94b-49f9-89f9-cd1ce0a47a425
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY5bb8ef99-a94b-49f9-89f9-cd1ce0a47a425
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY5bb8ef99-a94b-49f9-89f9-cd1ce0a47a425
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY5bb8ef99-a94b-49f9-89f9-cd1ce0a47a425
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY5bb8ef99-a94b-49f9-89f9-cd1ce0a47a425
307668APAP 32 MG/ML Oral SuspensionSY5bb8ef99-a94b-49f9-89f9-cd1ce0a47a425
828555APAP 32 MG/ML Oral Suspension [Tylenol]SY5bb8ef99-a94b-49f9-89f9-cd1ce0a47a425
828555Tylenol 160 MG per 5 ML Oral SuspensionSY5bb8ef99-a94b-49f9-89f9-cd1ce0a47a425
828555Tylenol 32 MG/ML Oral SuspensionSY5bb8ef99-a94b-49f9-89f9-cd1ce0a47a425
828555Tylenol Infants 160 MG in 5 mL Oral SuspensionSY5bb8ef99-a94b-49f9-89f9-cd1ce0a47a425

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-177-08505800177081 BOTTLE in 1 CARTON (50580-177-08) / 240 mL in 1 BOTTLE1 bottle2021-07-010000-00-00NoNoCurrent