TYLENOL Extra Strength

Product NDC
50580-490
11-digit product format
505800490
Labeler code
50580
Product ID
50580-490_4eda2e16-ed91-59d6-e063-6394a90abf72
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-30
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC201b860d-dc3c-4380-affa-e757bf2103cf2026-04-07WarningsExact 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 you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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. 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 you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 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. If pregnant or breast-feeding, ask a health professional before use. 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
TYLENOL Extra Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui198440, 209459

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
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332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
377068df-225f-7318-a910-a1987cdfa361Product name320170608
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
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96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
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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
50580-490-02TYLENOL Extra Strength200 in 1 BOTTLETABLET, COATED2008
50580-490-02TYLENOL Extra Strength1 in 1 CARTONTABLET, COATED18
50580-490-10TYLENOL Extra Strength1 in 1 CARTONTABLET, COATED18
50580-490-10TYLENOL Extra Strength100 in 1 BOTTLETABLET, COATED1008
50580-490-20TYLENOL Extra Strength100 in 1 BOTTLETABLET, COATED1008
50580-490-20TYLENOL Extra Strength2 in 1 CARTONTABLET, COATED28
50580-490-24TYLENOL Extra Strength1 in 1 CARTONTABLET, COATED18
50580-490-24TYLENOL Extra Strength24 in 1 BOTTLETABLET, COATED248
50580-490-25TYLENOL Extra Strength225 in 1 BOTTLETABLET, COATED2258
50580-490-25TYLENOL Extra Strength1 in 1 CARTONTABLET, COATED18
50580-490-50TYLENOL Extra Strength1 in 1 CARTONTABLET, COATED18
50580-490-50TYLENOL Extra Strength50 in 1 BOTTLETABLET, COATED508
50580-490-90TYLENOL Extra Strength290 in 1 BOTTLETABLET, COATED2908
50580-490-25TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief225 in 1 BOTTLETABLET, COATED225500 mg1
50580-490-25TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief1 in 1 CARTONTABLET, COATED500 mg1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-490TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [KENVUE BRANDS LLC]6Current NDC, Legacy NDC, 13 package rows20241109_201b860d-dc3c-4380-affa-e757bf2103cf.zip
50580-490TYLENOL EXTRA STRENGTH / TYLENOL PRECISE COOLING PAIN RELIEF (ACETAMINOPHEN, LIDOCAINE, MENTHOL) KIT [KENVUE BRANDS LLC]1Current NDC, Legacy NDC20241204_2611e984-0dd5-bda1-e063-6394a90a559a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN201b860d-dc3c-4380-affa-e757bf2103cf8
209459Tylenol Extra Strength 500 MG Oral TabletPSN201b860d-dc3c-4380-affa-e757bf2103cf8
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD201b860d-dc3c-4380-affa-e757bf2103cf8
198440acetaminophen 500 MG Oral TabletSCD201b860d-dc3c-4380-affa-e757bf2103cf8
198440APAP 500 MG Oral TabletSY201b860d-dc3c-4380-affa-e757bf2103cf8
209459APAP 500 MG Oral Tablet [Tylenol]SY201b860d-dc3c-4380-affa-e757bf2103cf8
209459Tylenol 500 MG Oral TabletSY201b860d-dc3c-4380-affa-e757bf2103cf8
209459Tylenol Extra Strength 500 MG Oral TabletSY201b860d-dc3c-4380-affa-e757bf2103cf8
198440acetaminophen 500 MG Oral TabletPSN2611e984-0dd5-bda1-e063-6394a90a559a1
250912lidocaine 4 % / menthol 1 % Topical CreamPSN2611e984-0dd5-bda1-e063-6394a90a559a1
209459Tylenol Extra Strength 500 MG Oral TabletPSN2611e984-0dd5-bda1-e063-6394a90a559a1
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD2611e984-0dd5-bda1-e063-6394a90a559a1
198440acetaminophen 500 MG Oral TabletSCD2611e984-0dd5-bda1-e063-6394a90a559a1
250912lidocaine 40 MG/ML / menthol 10 MG/ML Topical CreamSCD2611e984-0dd5-bda1-e063-6394a90a559a1
198440APAP 500 MG Oral TabletSY2611e984-0dd5-bda1-e063-6394a90a559a1
209459APAP 500 MG Oral Tablet [Tylenol]SY2611e984-0dd5-bda1-e063-6394a90a559a1
250912lidocaine 4 % / menthol 1 % Topical CreamSY2611e984-0dd5-bda1-e063-6394a90a559a1
209459Tylenol 500 MG Oral TabletSY2611e984-0dd5-bda1-e063-6394a90a559a1
209459Tylenol Extra Strength 500 MG Oral TabletSY2611e984-0dd5-bda1-e063-6394a90a559a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-490-02505800490021 BOTTLE in 1 CARTON (50580-490-02) / 200 TABLET, COATED in 1 BOTTLE1 bottle2026-06-010Current
50580-490-10505800490101 BOTTLE in 1 CARTON (50580-490-10) / 100 TABLET, COATED in 1 BOTTLE1 bottle2021-04-300000-00-00NoNoCurrent
50580-490-20505800490202 BOTTLE in 1 CARTON (50580-490-20) / 100 TABLET, COATED in 1 BOTTLE2 bottle2025-05-05NoNoCurrent
50580-490-24505800490241 BOTTLE in 1 CARTON (50580-490-24) / 24 TABLET, COATED in 1 BOTTLE1 bottle2021-04-300000-00-00NoNoCurrent
50580-490-25505800490251 BOTTLE in 1 CARTON (50580-490-25) / 225 TABLET, COATED in 1 BOTTLE1 bottle2021-04-300000-00-00NoNoCurrent
50580-490-50505800490501 BOTTLE in 1 CARTON (50580-490-50) / 50 TABLET, COATED in 1 BOTTLE1 bottle2021-04-300000-00-00NoNoCurrent
50580-490-9050580049090290 TABLET, COATED in 1 BOTTLE (50580-490-90) 2021-04-300000-00-00NoNoCurrent