FDA.reportPublic FDA data

Infants TYLENOL

Product NDC
50580-599
11-digit product format
505800599
Labeler code
50580
Product ID
50580-599_2e8d9ab2-5131-8810-e063-6394a90aba9c
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
2017-06-26
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50580-599-012024-02-06C16284748780-11030e365-1a04-111a-e063-dadaa90a10e2Infants' TYLENOL ®
50580-599-022024-02-06C16284748780-11030e365-1a04-111a-e063-dadaa90a10e2Infants' TYLENOL ®
50580-599-032024-02-06C16284748780-11030e365-1a04-111a-e063-dadaa90a10e2Infants' TYLENOL ®
50580-599-012024-01-30C16284748780-11030e365-1a04-111a-e063-dadaa90a10e2Infants' TYLENOL ®
50580-599-022024-01-30C16284748780-11030e365-1a04-111a-e063-dadaa90a10e2Infants' TYLENOL ®
50580-599-032024-01-30C16284748780-11030e365-1a04-111a-e063-dadaa90a10e2Infants' TYLENOL ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-599-01Infants TYLENOL1 in 1 CARTONSUSPENSION115
50580-599-01Infants TYLENOL60 mL in 1 BOTTLESUSPENSION6015
50580-599-02Infants TYLENOL60 mL in 1 BOTTLESUSPENSION6015
50580-599-02Infants TYLENOL2 in 1 CARTONSUSPENSION215
50580-599-03Infants TYLENOL1 in 1 CARTONSUSPENSION115
50580-599-03Infants TYLENOL30 mL in 1 BOTTLESUSPENSION3015
50580-599-03Gentle Care Kit1 in 1 CARTONSUSPENSION160 mg in 5mL1
50580-599-03Gentle Care Kit30 mL in 1 BOTTLESUSPENSION30 mL160 mg in 5mL1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-599-01ML - Milliliter50580-599f23bdcb2-a6bf-4c37-b48f-ef996e84244012020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-599INFANTS TYLENOL (ACETAMINOPHEN) SUSPENSION [KENVUE BRANDS LLC]15Current NDC, Legacy NDC, 6 package rows20250226_f9de7c2f-016b-4f40-8b5e-141ad194be97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNf9de7c2f-016b-4f40-8b5e-141ad194be9715
828555Tylenol 160 MG in 5 mL Oral SuspensionPSNf9de7c2f-016b-4f40-8b5e-141ad194be9715
828555acetaminophen 32 MG/ML Oral Suspension [Tylenol]SBDf9de7c2f-016b-4f40-8b5e-141ad194be9715
307668acetaminophen 32 MG/ML Oral SuspensionSCDf9de7c2f-016b-4f40-8b5e-141ad194be9715
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYf9de7c2f-016b-4f40-8b5e-141ad194be9715
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYf9de7c2f-016b-4f40-8b5e-141ad194be9715
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYf9de7c2f-016b-4f40-8b5e-141ad194be9715
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYf9de7c2f-016b-4f40-8b5e-141ad194be9715
307668APAP 32 MG/ML Oral SuspensionSYf9de7c2f-016b-4f40-8b5e-141ad194be9715
828555APAP 32 MG/ML Oral Suspension [Tylenol]SYf9de7c2f-016b-4f40-8b5e-141ad194be9715
828555Tylenol 160 MG per 5 ML Oral SuspensionSYf9de7c2f-016b-4f40-8b5e-141ad194be9715
828555Tylenol 32 MG/ML Oral SuspensionSYf9de7c2f-016b-4f40-8b5e-141ad194be9715
828555Tylenol Infants 160 MG in 5 mL Oral SuspensionSYf9de7c2f-016b-4f40-8b5e-141ad194be9715
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
1797059Desitin 40 % Topical PastePSN4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
828555Tylenol 160 MG in 5 mL Oral SuspensionPSN4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
1094560zinc oxide 40 % Topical PastePSN4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
828555acetaminophen 32 MG/ML Oral Suspension [Tylenol]SBD4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
1797059zinc oxide 0.4 MG/MG Paste [Desitin]SBD4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
307668acetaminophen 32 MG/ML Oral SuspensionSCD4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
1094560zinc oxide 0.4 MG/MG PasteSCD4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
307668APAP 32 MG/ML Oral SuspensionSY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
828555APAP 32 MG/ML Oral Suspension [Tylenol]SY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
1797059Desitin 40 % Topical PasteSY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
828555Tylenol 160 MG per 5 ML Oral SuspensionSY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
828555Tylenol 32 MG/ML Oral SuspensionSY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
828555Tylenol Infants 160 MG in 5 mL Oral SuspensionSY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
1094560zinc oxide 40 % PasteSY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
1094560ZNO 0.4 MG/MG PasteSY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1
1797059ZNO 0.4 MG/MG Paste [Desitin]SY4b8f7a5a-2fc4-ea00-e063-6294a90ab95b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-599-01505800599011 BOTTLE in 1 CARTON (50580-599-01) / 60 mL in 1 BOTTLE1 bottle2017-06-260000-00-00NoNoCurrent
50580-599-02505800599022 BOTTLE in 1 CARTON (50580-599-02) / 60 mL in 1 BOTTLE2 bottle2022-03-24NoNoCurrent
50580-599-03505800599031 BOTTLE in 1 CARTON (50580-599-03) / 30 mL in 1 BOTTLE1 bottle2020-04-200000-00-00NoNoCurrent