FDA.reportPublic FDA data

TYLENOL Extra Strength

Product NDC
50580-449
Requested package NDC
50580-449-08
11-digit product format
505800449
Labeler code
50580
Product ID
50580-449_48dfd489-9fa0-ff51-e063-6294a90a25b0
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1984-08-19
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 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
198440Internal RxNorm lookup
209459Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
59773893-09a8-47a2-943a-e9ea9da4458aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
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
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
377068df-225f-7318-a910-a1987cdfa361Product name320170608
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct 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
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50580-449-002022-08-24TYLENOL Extra Strength
50580-449-002022-08-24TYLENOL Extra Strength
50580-449-052022-08-24TYLENOL Extra Strength
50580-449-052022-08-24TYLENOL Extra Strength
50580-449-082022-08-24TYLENOL Extra Strength
50580-449-082022-08-24TYLENOL Extra Strength
50580-449-092022-08-24TYLENOL Extra Strength
50580-449-092022-08-24TYLENOL Extra Strength
50580-449-102022-08-24TYLENOL Extra Strength
50580-449-102022-08-24TYLENOL Extra Strength
50580-449-112022-08-24TYLENOL Extra Strength
50580-449-112022-08-24TYLENOL Extra Strength
50580-449-122022-08-24TYLENOL Extra Strength
50580-449-122022-08-24TYLENOL Extra Strength
50580-449-132022-08-24TYLENOL Extra Strength
50580-449-132022-08-24TYLENOL Extra Strength
50580-449-142022-08-24TYLENOL Extra Strength
50580-449-142022-08-24TYLENOL Extra Strength
50580-449-152022-08-24TYLENOL Extra Strength
50580-449-152022-08-24TYLENOL Extra Strength
50580-449-232022-08-24TYLENOL Extra Strength
50580-449-232022-08-24TYLENOL Extra Strength
50580-449-312022-08-24TYLENOL Extra Strength
50580-449-312022-08-24TYLENOL Extra Strength
50580-449-342022-08-24TYLENOL Extra Strength
50580-449-342022-08-24TYLENOL Extra Strength
50580-449-352022-08-24TYLENOL Extra Strength
50580-449-352022-08-24TYLENOL Extra Strength
50580-449-362022-08-24TYLENOL Extra Strength
50580-449-362022-08-24TYLENOL Extra Strength
50580-449-612022-08-24TYLENOL Extra Strength
50580-449-612022-08-24TYLENOL Extra Strength
50580-449-622022-08-24TYLENOL Extra Strength
50580-449-622022-08-24TYLENOL Extra Strength
50580-449-842022-08-24TYLENOL Extra Strength
50580-449-842022-08-24TYLENOL Extra Strength
50580-449-852022-08-24TYLENOL Extra Strength
50580-449-852022-08-24TYLENOL Extra Strength
50580-449-862022-08-24TYLENOL Extra Strength
50580-449-862022-08-24TYLENOL Extra Strength
50580-449-872022-08-24TYLENOL Extra Strength
50580-449-872022-08-24TYLENOL Extra Strength
50580-449-962022-08-24TYLENOL Extra Strength
50580-449-962022-08-24TYLENOL Extra Strength
50580-449-972022-08-24TYLENOL Extra Strength
50580-449-972022-08-24TYLENOL Extra Strength
50580-449-982022-08-24TYLENOL Extra Strength
50580-449-982022-08-24TYLENOL Extra Strength
50580-449-002022-07-29TYLENOL Extra Strength
50580-449-002022-07-29TYLENOL Extra Strength
50580-449-052022-07-29TYLENOL Extra Strength
50580-449-052022-07-29TYLENOL Extra Strength
50580-449-082022-07-29TYLENOL Extra Strength
50580-449-082022-07-29TYLENOL Extra Strength
50580-449-092022-07-29TYLENOL Extra Strength
50580-449-092022-07-29TYLENOL Extra Strength
50580-449-102022-07-29TYLENOL Extra Strength
50580-449-102022-07-29TYLENOL Extra Strength
50580-449-112022-07-29TYLENOL Extra Strength
50580-449-112022-07-29TYLENOL Extra Strength
50580-449-122022-07-29TYLENOL Extra Strength
50580-449-122022-07-29TYLENOL Extra Strength
50580-449-132022-07-29TYLENOL Extra Strength
50580-449-132022-07-29TYLENOL Extra Strength
50580-449-142022-07-29TYLENOL Extra Strength
50580-449-142022-07-29TYLENOL Extra Strength
50580-449-152022-07-29TYLENOL Extra Strength
50580-449-152022-07-29TYLENOL Extra Strength
50580-449-232022-07-29TYLENOL Extra Strength
50580-449-232022-07-29TYLENOL Extra Strength
50580-449-312022-07-29TYLENOL Extra Strength
50580-449-312022-07-29TYLENOL Extra Strength
50580-449-342022-07-29TYLENOL Extra Strength
50580-449-342022-07-29TYLENOL Extra Strength
50580-449-352022-07-29TYLENOL Extra Strength
50580-449-352022-07-29TYLENOL Extra Strength
50580-449-362022-07-29TYLENOL Extra Strength
50580-449-362022-07-29TYLENOL Extra Strength
50580-449-612022-07-29TYLENOL Extra Strength
50580-449-612022-07-29TYLENOL Extra Strength
50580-449-622022-07-29TYLENOL Extra Strength
50580-449-622022-07-29TYLENOL Extra Strength
50580-449-842022-07-29TYLENOL Extra Strength
50580-449-842022-07-29TYLENOL Extra Strength
50580-449-852022-07-29TYLENOL Extra Strength
50580-449-852022-07-29TYLENOL Extra Strength
50580-449-862022-07-29TYLENOL Extra Strength
50580-449-862022-07-29TYLENOL Extra Strength
50580-449-872022-07-29TYLENOL Extra Strength
50580-449-872022-07-29TYLENOL Extra Strength
50580-449-962022-07-29TYLENOL Extra Strength
50580-449-962022-07-29TYLENOL Extra Strength
50580-449-972022-07-29TYLENOL Extra Strength
50580-449-972022-07-29TYLENOL Extra Strength
50580-449-982022-07-29TYLENOL Extra Strength
50580-449-982022-07-29TYLENOL Extra Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-449-00TYLENOL Extra Strength125 in 1 BOTTLE, PLASTICTABLET, FILM COATED12523
50580-449-00TYLENOL Extra Strength1 in 1 CARTONTABLET, FILM COATED123
50580-449-05TYLENOL Extra Strength24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2423
50580-449-05TYLENOL Extra Strength1 in 1 CARTONTABLET, FILM COATED123
50580-449-08TYLENOL Extra Strength2 in 1 POUCHTABLET, FILM COATED223
50580-449-09TYLENOL Extra Strength100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10023
50580-449-09TYLENOL Extra Strength1 in 1 CARTONTABLET, FILM COATED123
50580-449-10TYLENOL Extra Strength2 in 1 POUCHTABLET, FILM COATED223
50580-449-10TYLENOL Extra Strength50 in 1 TRAYTABLET, FILM COATED5023
50580-449-11TYLENOL Extra Strength2 in 1 POUCHTABLET, FILM COATED223
50580-449-11TYLENOL Extra Strength50 in 1 TRAYTABLET, FILM COATED5023
50580-449-12TYLENOL Extra Strength10 in 1 VIAL, PLASTICTABLET, FILM COATED1023
50580-449-12TYLENOL Extra Strength12 in 1 PACKAGETABLET, FILM COATED1223
50580-449-13TYLENOL Extra Strength2 in 1 POUCHTABLET, FILM COATED223
50580-449-13TYLENOL Extra Strength3 in 1 CARTONTABLET, FILM COATED323
50580-449-14TYLENOL Extra Strength2 in 1 POUCHTABLET, FILM COATED223
50580-449-15TYLENOL Extra Strength10 in 1 VIAL, PLASTICTABLET, FILM COATED1023
50580-449-23TYLENOL Extra Strength1 in 1 CARTONTABLET, FILM COATED123
50580-449-23TYLENOL Extra Strength150 in 1 BOTTLE, PLASTICTABLET, FILM COATED15023
50580-449-31TYLENOL Extra Strength1 in 1 CARTONTABLET, FILM COATED123
50580-449-31TYLENOL Extra Strength36 in 1 BOTTLE, PLASTICTABLET, FILM COATED3623
50580-449-34TYLENOL Extra Strength325 in 1 BOTTLE, PLASTICTABLET, FILM COATED32523
50580-449-35TYLENOL Extra Strength24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2423
50580-449-35TYLENOL Extra Strength1 in 1 CARTONTABLET, FILM COATED123
50580-449-36TYLENOL Extra Strength100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10023
50580-449-36TYLENOL Extra Strength1 in 1 CARTONTABLET, FILM COATED123
50580-449-37TYLENOL Extra Strength320 in 1 BOTTLETABLET, FILM COATED32023
50580-449-61TYLENOL Extra Strength225 in 1 BOTTLE, PLASTICTABLET, FILM COATED22523
50580-449-61TYLENOL Extra Strength1 in 1 CARTONTABLET, FILM COATED123
50580-449-62TYLENOL Extra Strength325 in 1 BOTTLE, PLASTICTABLET, FILM COATED32523
50580-449-66TYLENOL Extra Strength100 in 1 BOTTLETABLET, FILM COATED10023
50580-449-66TYLENOL Extra Strength2 in 1 CARTONTABLET, FILM COATED223
50580-449-84TYLENOL Extra Strength2 in 1 POUCHTABLET, FILM COATED223
50580-449-85TYLENOL Extra Strength2 in 1 POUCHTABLET, FILM COATED223
50580-449-85TYLENOL Extra Strength50 in 1 TRAYTABLET, FILM COATED5023
50580-449-86TYLENOL Extra Strength2 in 1 POUCHTABLET, FILM COATED223
50580-449-86TYLENOL Extra Strength50 in 1 TRAYTABLET, FILM COATED5023
50580-449-87TYLENOL Extra Strength3 in 1 CARTONTABLET, FILM COATED323
50580-449-87TYLENOL Extra Strength2 in 1 POUCHTABLET, FILM COATED223
50580-449-96TYLENOL Extra Strength1 in 1 CARTONTABLET, FILM COATED123
50580-449-96TYLENOL Extra Strength50 in 1 BOTTLETABLET, FILM COATED5023
50580-449-97TYLENOL Extra Strength249 in 1 PACKAGE, COMBINATIONTABLET, FILM COATED24923
50580-449-98TYLENOL Extra Strength110 in 1 PACKAGE, COMBINATIONTABLET, FILM COATED11023
50580-449-08Johnson and Johnson All Purpose First Aid Kit2 in 1 POUCHTABLET, FILM COATED4500 mg7
50580-449-08Johnson and Johnson First Aid All Purpose160 CT2 in 1 POUCHTABLET, FILM COATED4500 mg3
50580-449-08Johnson and Johnson First Aid Travel Ready80 CT2 in 1 POUCHTABLET, FILM COATED4500 mg3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-449-00EA - Each50580-4496d4b05b4-6ad3-4928-8e25-c8b959463b2d12012-07-24
50580-449-05EA - Each50580-44988acde81-d037-4e5c-bb0c-84fb4f0c8a8712012-07-24
50580-449-07EA - Each50580-44920279d46-6713-4547-84fb-9a08de2e2d1512012-07-24
50580-449-09EA - Each50580-449c71a951e-137e-45aa-9cf4-fcf45d883ade12012-07-24
50580-449-10EA - Each50580-4493e2a7f0e-aa78-48c7-ad46-b671d85aa97912012-07-24
50580-449-12EA - Each50580-449241c2584-6250-4617-9d2b-bea53196e24512014-11-05
50580-449-13EA - Each50580-449e9e4683d-f503-45ba-935a-cfc8788a114a12015-10-02
50580-449-15EA - Each50580-44972f946f0-efd3-40f2-a3f4-b5bb480bb2f512012-07-24
50580-449-23EA - Each50580-449eb924eae-392e-408d-99ad-5b9ccf2f4b1e12012-07-24
50580-449-35EA - Each50580-449ccc5e685-e933-4c54-9a29-4f520edd3cf212013-03-03
50580-449-36EA - Each50580-449fe30c11b-8a2f-49f0-b4f9-7e2c03350a3612013-03-03
50580-449-37EA - Each50580-449d5cb5c35-153e-4f83-b28f-be9370e40ddd12026-04-20
50580-449-61EA - Each50580-449690e1cfe-fa00-469e-9039-75db9bb6375b12023-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]5
AcetaminophenACTIVE MOIETY362O9ITL9DTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]5
aluminum oxideINACTIVE INGREDIENTLMI26O6933TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]5
carnauba waxINACTIVE INGREDIENTR12CBM0EIZTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]5
castor oilINACTIVE INGREDIENTD5340Y2I9GTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]5
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOATYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]5
hypromellosesINACTIVE INGREDIENT3NXW29V3WOTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]5
magnesium stearateINACTIVE INGREDIENT70097M6I30TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]5
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ATYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]5
powdered celluloseINACTIVE INGREDIENTSMD1X3XO9MTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]5
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]5
shellacINACTIVE INGREDIENT46N107B71OTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]5
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]5
starch, cornINACTIVE INGREDIENTO8232NY3SJTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]5
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]5
AcetaminophenACTIVE INGREDIENT362O9ITL9DTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [A-S MEDICATION SOLUTIONS LLC]1
AcetaminophenACTIVE MOIETY362O9ITL9DTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [A-S MEDICATION SOLUTIONS LLC]1
aluminum oxideINACTIVE INGREDIENTLMI26O6933TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [A-S MEDICATION SOLUTIONS LLC]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [A-S MEDICATION SOLUTIONS LLC]1
castor oilINACTIVE INGREDIENTD5340Y2I9GTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [A-S MEDICATION SOLUTIONS LLC]1
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOATYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [A-S MEDICATION SOLUTIONS LLC]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [A-S MEDICATION SOLUTIONS LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [A-S MEDICATION SOLUTIONS LLC]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ATYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [A-S MEDICATION SOLUTIONS LLC]1
powdered celluloseINACTIVE INGREDIENTSMD1X3XO9MTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [A-S MEDICATION SOLUTIONS LLC]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [A-S MEDICATION SOLUTIONS LLC]1
shellacINACTIVE INGREDIENT46N107B71OTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [A-S MEDICATION SOLUTIONS LLC]1
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [A-S MEDICATION SOLUTIONS LLC]1
starch, cornINACTIVE INGREDIENTO8232NY3SJTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [A-S MEDICATION SOLUTIONS LLC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-449TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [KENVUE BRANDS LLC]22Current NDC, Legacy NDC, 43 package rows20250221_59773893-09a8-47a2-943a-e9ea9da4458a.zip
50580-449JOHNSON AND JOHNSON ALL PURPOSE FIRST AID KIT (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC]6Current NDC, Legacy NDC20241116_5cdb47c5-7951-4279-8a05-0a3199d3dd45.zip
50580-449JOHNSON AND JOHNSON FIRST AID ALL PURPOSE 160 CT (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC]2Current NDC, Legacy NDC20241116_f3933330-2550-4a88-e053-2a95a90a3997.zip
50580-449JOHNSON AND JOHNSON FIRST AID TRAVEL READY 80 CT (ACETAMINOPHEN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC]2Current NDC, Legacy NDC20241116_f388f105-48ba-4616-e053-2a95a90a0049.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 1 of 85 · 1,681 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief Acetaminophen 325 mgACETAMINOPHENNUVICARE LLC49a59b79-b8b4-4bf5-a403-0a14751efc552026-07-30WarningsExact identifier
application number: M013
KinderFarms Childrens Pain and FeverACETAMINOPHENKinderFarms, LLC4f86419a-b940-a9c6-e063-6394a90a6a2b2026-07-30WarningsExact identifier
application number: M013
KinderFarms Infants Pain and FeverACETAMINOPHENKinderFarms, LLC5468b149-8fac-8d6a-e063-6294a90a8c512026-07-29WarningsExact identifier
application number: M013
AspirinASPIRINDolgencorp, Inc. (DOLLAR GENERAL & REXALL)3ba0a9f2-062a-401e-82eb-54383a8223662026-07-29WarningsExact identifier
application number: M013
Aspirin Low Dose ChewableASPIRINBetter Living Brands, LLC7afce7b4-c86a-43f7-83cf-15ebffba2f352026-07-28WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLCf818996c-36d2-4d3d-af3e-39949157edb92026-07-28WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLL.N.K. International, Inc.03b871e8-3e14-4ed8-a978-45129255b2722026-07-27WarningsExact identifier
application number: M013
Pain Relief Acetaminophen PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLRite Aid Corporation17d27771-a112-474f-9a58-29af0d7e1af32026-07-27WarningsExact identifier
application number: M013
Children Pain Relief GummyACETAMINOPHEN CHILDREN GUMMYGummy USA5513db67-f023-7f47-e063-6294a90a27572026-07-24WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLC2143cc16-86db-4060-96da-5c228ae9207b2026-07-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSoftgel Healthcare Pvt Ltd352bb451-ffdc-411a-e063-6294a90a8cf52026-07-24WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.fdb7331a-d029-8b2a-e053-6294a90adfcd2026-07-24WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLC5ada044e-50e8-4874-ac04-df5f1f9e735d2026-07-24WarningsExact identifier
application number: M013
childrens fever reducer and pain relieverACETAMINOPHENRite Aid Corporationa63727c3-64d8-4ae9-8da3-974cae6beed22026-07-24WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLCe4a2566e-48ec-4602-87e3-143398d15f332026-07-24WarningsExact identifier
application number: M013
infants fever reducer and pain relieverACETAMINOPHENRite Aid Corporation920e7055-7ed1-4db4-9215-f8933078bb7b2026-07-24WarningsExact identifier
application number: M013
Dye Free Pain and Fever ChildrensACETAMINOPHENWalgreensc6665c11-9a01-4472-a444-acadb1de0b692026-07-23WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENKenvue Brands LLC103d109d-f520-409c-8da2-eb6b0fbec8912026-07-22WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCce58105b-f010-47af-8f31-6dd4ce4e9cba2026-07-22WarningsExact identifier
application number: M013
Vicks PainQuil PAIN RELIEVERACETAMINOPHENThe Procter & Gamble Manufacturing Company0ad7b313-5d72-4cc0-97f0-1a30770350af2026-07-22WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN59773893-09a8-47a2-943a-e9ea9da4458a23
209459Tylenol Extra Strength 500 MG Oral TabletPSN59773893-09a8-47a2-943a-e9ea9da4458a23
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD59773893-09a8-47a2-943a-e9ea9da4458a23
198440acetaminophen 500 MG Oral TabletSCD59773893-09a8-47a2-943a-e9ea9da4458a23
198440APAP 500 MG Oral TabletSY59773893-09a8-47a2-943a-e9ea9da4458a23
209459APAP 500 MG Oral Tablet [Tylenol]SY59773893-09a8-47a2-943a-e9ea9da4458a23
209459Tylenol 500 MG Oral TabletSY59773893-09a8-47a2-943a-e9ea9da4458a23
209459Tylenol Extra Strength 500 MG Oral TabletSY59773893-09a8-47a2-943a-e9ea9da4458a23
198440acetaminophen 500 MG Oral TabletPSN1b4db77f-b254-4db5-8e98-d46850140a9b18
209459Tylenol Extra Strength 500 MG Oral TabletPSN1b4db77f-b254-4db5-8e98-d46850140a9b18
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD1b4db77f-b254-4db5-8e98-d46850140a9b18
198440acetaminophen 500 MG Oral TabletSCD1b4db77f-b254-4db5-8e98-d46850140a9b18
198440APAP 500 MG Oral TabletSY1b4db77f-b254-4db5-8e98-d46850140a9b18
209459APAP 500 MG Oral Tablet [Tylenol]SY1b4db77f-b254-4db5-8e98-d46850140a9b18
209459Tylenol 500 MG Oral TabletSY1b4db77f-b254-4db5-8e98-d46850140a9b18
209459Tylenol Extra Strength 500 MG Oral TabletSY1b4db77f-b254-4db5-8e98-d46850140a9b18
198440acetaminophen 500 MG Oral TabletPSN5cdb47c5-7951-4279-8a05-0a3199d3dd457
1111764Benadryl Itch Stopping, Extra Strength 2 % / 0.1 % Topical CreamPSN5cdb47c5-7951-4279-8a05-0a3199d3dd457
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN5cdb47c5-7951-4279-8a05-0a3199d3dd457
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamPSN5cdb47c5-7951-4279-8a05-0a3199d3dd457
209459Tylenol Extra Strength 500 MG Oral TabletPSN5cdb47c5-7951-4279-8a05-0a3199d3dd457
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD5cdb47c5-7951-4279-8a05-0a3199d3dd457
1111764diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream [Benadryl Itch Stopping]SBD5cdb47c5-7951-4279-8a05-0a3199d3dd457
198440acetaminophen 500 MG Oral TabletSCD5cdb47c5-7951-4279-8a05-0a3199d3dd457
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD5cdb47c5-7951-4279-8a05-0a3199d3dd457
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD5cdb47c5-7951-4279-8a05-0a3199d3dd457
198440APAP 500 MG Oral TabletSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
209459APAP 500 MG Oral Tablet [Tylenol]SY5cdb47c5-7951-4279-8a05-0a3199d3dd457
1111764Benadryl Itch Stopping, Extra Strength (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical CreamSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
209459Tylenol 500 MG Oral TabletSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
209459Tylenol Extra Strength 500 MG Oral TabletSY5cdb47c5-7951-4279-8a05-0a3199d3dd457
198440acetaminophen 500 MG Oral TabletPSN86b6ac01-3866-4cd8-a1be-9babb6ff311b6
209459Tylenol Extra Strength 500 MG Oral TabletPSN86b6ac01-3866-4cd8-a1be-9babb6ff311b6
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD86b6ac01-3866-4cd8-a1be-9babb6ff311b6
198440acetaminophen 500 MG Oral TabletSCD86b6ac01-3866-4cd8-a1be-9babb6ff311b6
198440APAP 500 MG Oral TabletSY86b6ac01-3866-4cd8-a1be-9babb6ff311b6
209459APAP 500 MG Oral Tablet [Tylenol]SY86b6ac01-3866-4cd8-a1be-9babb6ff311b6
209459Tylenol 500 MG Oral TabletSY86b6ac01-3866-4cd8-a1be-9babb6ff311b6
209459Tylenol Extra Strength 500 MG Oral TabletSY86b6ac01-3866-4cd8-a1be-9babb6ff311b6
198440acetaminophen 500 MG Oral TabletPSN68b0be18-198e-48c7-a7a2-e81cbcf0fbe85
209459Tylenol Extra Strength 500 MG Oral TabletPSN68b0be18-198e-48c7-a7a2-e81cbcf0fbe85
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD68b0be18-198e-48c7-a7a2-e81cbcf0fbe85
198440acetaminophen 500 MG Oral TabletSCD68b0be18-198e-48c7-a7a2-e81cbcf0fbe85
198440APAP 500 MG Oral TabletSY68b0be18-198e-48c7-a7a2-e81cbcf0fbe85
209459APAP 500 MG Oral Tablet [Tylenol]SY68b0be18-198e-48c7-a7a2-e81cbcf0fbe85
209459Tylenol 500 MG Oral TabletSY68b0be18-198e-48c7-a7a2-e81cbcf0fbe85
209459Tylenol Extra Strength 500 MG Oral TabletSY68b0be18-198e-48c7-a7a2-e81cbcf0fbe85
198440acetaminophen 500 MG Oral TabletPSN919c0b9c-9267-4214-8ace-633438f8e7a43
198440acetaminophen 500 MG Oral TabletPSNf3933330-2550-4a88-e053-2a95a90a39973
198440acetaminophen 500 MG Oral TabletPSNf388f105-48ba-4616-e053-2a95a90a00493
198440acetaminophen 500 MG Oral TabletPSN8ed90757-833e-f4d9-e053-2995a90a29db3
1111764Benadryl Itch Stopping, Extra Strength 2 % / 0.1 % Topical CreamPSNf3933330-2550-4a88-e053-2a95a90a39973
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSNf3933330-2550-4a88-e053-2a95a90a39973
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamPSNf3933330-2550-4a88-e053-2a95a90a39973
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamPSNf388f105-48ba-4616-e053-2a95a90a00493
209459Tylenol Extra Strength 500 MG Oral TabletPSNf3933330-2550-4a88-e053-2a95a90a39973
209459Tylenol Extra Strength 500 MG Oral TabletPSN8ed90757-833e-f4d9-e053-2995a90a29db3
209459Tylenol Extra Strength 500 MG Oral TabletPSNf388f105-48ba-4616-e053-2a95a90a00493
209459Tylenol Extra Strength 500 MG Oral TabletPSN919c0b9c-9267-4214-8ace-633438f8e7a43
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBDf3933330-2550-4a88-e053-2a95a90a39973
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD8ed90757-833e-f4d9-e053-2995a90a29db3
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBDf388f105-48ba-4616-e053-2a95a90a00493
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD919c0b9c-9267-4214-8ace-633438f8e7a43
1111764diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream [Benadryl Itch Stopping]SBDf3933330-2550-4a88-e053-2a95a90a39973
198440acetaminophen 500 MG Oral TabletSCDf388f105-48ba-4616-e053-2a95a90a00493
198440acetaminophen 500 MG Oral TabletSCDf3933330-2550-4a88-e053-2a95a90a39973
198440acetaminophen 500 MG Oral TabletSCD8ed90757-833e-f4d9-e053-2995a90a29db3
198440acetaminophen 500 MG Oral TabletSCD919c0b9c-9267-4214-8ace-633438f8e7a43
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCDf3933330-2550-4a88-e053-2a95a90a39973
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCDf3933330-2550-4a88-e053-2a95a90a39973
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCDf388f105-48ba-4616-e053-2a95a90a00493
198440APAP 500 MG Oral TabletSY8ed90757-833e-f4d9-e053-2995a90a29db3
198440APAP 500 MG Oral TabletSYf3933330-2550-4a88-e053-2a95a90a39973
198440APAP 500 MG Oral TabletSYf388f105-48ba-4616-e053-2a95a90a00493
198440APAP 500 MG Oral TabletSY919c0b9c-9267-4214-8ace-633438f8e7a43
209459APAP 500 MG Oral Tablet [Tylenol]SYf3933330-2550-4a88-e053-2a95a90a39973

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50580-449-08505800449082 TABLET, FILM COATED in 1 POUCH (50580-449-08) 1984-08-190000-00-00NoNoCurrent