FDA.reportPublic FDA data

Infants TYLENOL

Product NDC
50580-325
11-digit product format
505800325
Labeler code
50580
Product ID
50580-325_216fda4f-79f4-5cca-e063-6294a90a27a8
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
2017-09-25
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Infants TYLENOL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui307668, 828555

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50580-325-012024-02-01C16284748780-11030e365-1be9-111a-e063-dadaa90a10e2Infants' TYLENOL
50580-325-012024-01-30C16284748780-11030e365-1be9-111a-e063-dadaa90a10e2Infants' TYLENOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-325-01Infants TYLENOL1 in 1 CARTONSUSPENSION111
50580-325-01Infants TYLENOL60 mL in 1 BOTTLESUSPENSION6011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-325-01ML - Milliliter50580-3250af60d51-546c-41ec-82ee-774443decf7b12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-325INFANTS TYLENOL (ACETAMINOPHEN) SUSPENSION [KENVUE BRANDS LLC]11Current NDC, Legacy NDC, 2 package rows20241109_997b9551-c222-4a9c-8ba1-09a5f97495fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN997b9551-c222-4a9c-8ba1-09a5f97495fa11
828555Tylenol 160 MG in 5 mL Oral SuspensionPSN997b9551-c222-4a9c-8ba1-09a5f97495fa11
828555acetaminophen 32 MG/ML Oral Suspension [Tylenol]SBD997b9551-c222-4a9c-8ba1-09a5f97495fa11
307668acetaminophen 32 MG/ML Oral SuspensionSCD997b9551-c222-4a9c-8ba1-09a5f97495fa11
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY997b9551-c222-4a9c-8ba1-09a5f97495fa11
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY997b9551-c222-4a9c-8ba1-09a5f97495fa11
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY997b9551-c222-4a9c-8ba1-09a5f97495fa11
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY997b9551-c222-4a9c-8ba1-09a5f97495fa11
307668APAP 32 MG/ML Oral SuspensionSY997b9551-c222-4a9c-8ba1-09a5f97495fa11
828555APAP 32 MG/ML Oral Suspension [Tylenol]SY997b9551-c222-4a9c-8ba1-09a5f97495fa11
828555Tylenol 160 MG per 5 ML Oral SuspensionSY997b9551-c222-4a9c-8ba1-09a5f97495fa11
828555Tylenol 32 MG/ML Oral SuspensionSY997b9551-c222-4a9c-8ba1-09a5f97495fa11
828555Tylenol Infants 160 MG in 5 mL Oral SuspensionSY997b9551-c222-4a9c-8ba1-09a5f97495fa11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-325-01505800325011 BOTTLE in 1 CARTON (50580-325-01) / 60 mL in 1 BOTTLE1 bottle2017-09-250000-00-00NoNoCurrent