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

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
Infants 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
f9de7c2f-016b-4f40-8b5e-141ad194be97Available on FDA.report

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, Related label table
NDCEffectiveRelated label
50580-599-012024-02-06Infants' TYLENOL ®
50580-599-022024-02-06Infants' TYLENOL ®
50580-599-032024-02-06Infants' TYLENOL ®
50580-599-012024-01-30Infants' TYLENOL ®
50580-599-022024-01-30Infants' TYLENOL ®
50580-599-032024-01-30Infants' 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

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 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENWestminster Pharmaceuticals, LLCace5ebac-ec11-4c26-b1e3-954b450ee6712021-05-04WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRIN 81 MGAllegiant Health8cacf02c-9925-40d4-92bc-78788aa0681a2020-11-11WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHEN 500 MGAllegiant Health8e60b78e-ef3c-4d44-b8d4-37cb8608a5c72020-03-13WarningsExact identifier
application number: M013
Acetaminophen 500mg ESACETAMINOPHEN 500MGAllegiant Health91acc132-01b6-467b-9af5-70f4dc93e0872019-01-08WarningsExact identifier
application number: M013
Acetaminophen 325mg RSACETAMINOPHEN 325MGAllegiant Health61c6d281-e59b-4277-bbce-f71c12c2a56d2019-01-07WarningsExact identifier
application number: M013
Cold Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAllegiant Health9a4c0c43-a71a-4e22-a3d5-9eb9622689a22019-01-02WarningsExact identifier
application number: M013
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 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