FDA.reportPublic FDA data

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

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
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
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
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct 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

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