Childrens TYLENOL

Product NDC
50580-170
11-digit product format
505800170
Labeler code
50580
Product ID
50580-170_21d2ce78-71b1-76a0-e063-6294a90ad014
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC46ddbfde-54ab-4373-b832-b9c0620b1e9d2024-11-07WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if your child has liver disease Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin When using this product do not exceed recommended dose (see overdose warning ) Stop use and ask a doctor if pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. Keep out of reach of children. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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 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
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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
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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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-170-01Childrens TYLENOL120 mL in 1 BOTTLESUSPENSION12013
50580-170-01Childrens TYLENOL1 in 1 CARTONSUSPENSION113
50580-170-02Childrens TYLENOL1 in 1 CARTONSUSPENSION113
50580-170-02Childrens TYLENOL240 mL in 1 BOTTLESUSPENSION24013
50580-170-03Childrens TYLENOL1 in 1 CARTONSUSPENSION113
50580-170-03Childrens TYLENOL2 in 1 PACKAGESUSPENSION213
50580-170-04Childrens TYLENOL3 in 1 PACKAGESUSPENSION313
50580-170-04Childrens TYLENOL1 in 1 CARTONSUSPENSION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-170-01ML - Milliliter50580-170d31b3e8f-f110-461e-8a57-ba609d8e3c2b12017-09-11
50580-170-02ML - Milliliter50580-1705a98a7a8-4b20-4581-88a6-dd1294bb44b512021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-170CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [KENVUE BRANDS LLC]13Current NDC, Legacy NDC, 8 package rows20241109_46ddbfde-54ab-4373-b832-b9c0620b1e9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN46ddbfde-54ab-4373-b832-b9c0620b1e9d13
828555Tylenol 160 MG in 5 mL Oral SuspensionPSN46ddbfde-54ab-4373-b832-b9c0620b1e9d13
828555acetaminophen 32 MG/ML Oral Suspension [Tylenol]SBD46ddbfde-54ab-4373-b832-b9c0620b1e9d13
307668acetaminophen 32 MG/ML Oral SuspensionSCD46ddbfde-54ab-4373-b832-b9c0620b1e9d13
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY46ddbfde-54ab-4373-b832-b9c0620b1e9d13
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY46ddbfde-54ab-4373-b832-b9c0620b1e9d13
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY46ddbfde-54ab-4373-b832-b9c0620b1e9d13
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY46ddbfde-54ab-4373-b832-b9c0620b1e9d13
307668APAP 32 MG/ML Oral SuspensionSY46ddbfde-54ab-4373-b832-b9c0620b1e9d13
828555APAP 32 MG/ML Oral Suspension [Tylenol]SY46ddbfde-54ab-4373-b832-b9c0620b1e9d13
828555Tylenol 160 MG per 5 ML Oral SuspensionSY46ddbfde-54ab-4373-b832-b9c0620b1e9d13
828555Tylenol 32 MG/ML Oral SuspensionSY46ddbfde-54ab-4373-b832-b9c0620b1e9d13
828555Tylenol Infants 160 MG in 5 mL Oral SuspensionSY46ddbfde-54ab-4373-b832-b9c0620b1e9d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-170-01505800170011 BOTTLE in 1 CARTON (50580-170-01) / 120 mL in 1 BOTTLE1 bottle2017-01-160000-00-00NoNoCurrent
50580-170-02505800170021 BOTTLE in 1 CARTON (50580-170-02) / 240 mL in 1 BOTTLE1 bottle2021-06-010000-00-00NoNoCurrent
50580-170-03505800170032 CARTON in 1 PACKAGE (50580-170-03) / 1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE2 carton2020-10-010000-00-00NoNoCurrent
50580-170-04505800170043 CARTON in 1 PACKAGE (50580-170-04) / 1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE3 carton2021-06-010000-00-00NoNoCurrent