FDA.reportPublic FDA data

TYLENOL EXTRA STRENGTH

Product NDC
50090-0005
11-digit product format
500900005
Labeler code
50090
Product ID
50090-0005_e60a942a-a0b3-420d-8c99-7a1c592f1dc9
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TYLENOL EXTRA STRENGTH
Listing expiration
2026-12-31

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
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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0005-02023-02-07C16284748780-19d75b9d0-e482-f424-e053-dadaa90a57ceTYLENOL EXTRA STRENGTH
50090-0005-02023-01-30C16284748780-19d75b9d0-e482-f424-e053-dadaa90a57ceTYLENOL EXTRA STRENGTH
50090-0005-02021-09-11C16284748780-19d75b9d0-e482-f424-e053-dadaa90a57ceTYLENOL EXTRA STRENGTH
50090-0005-02020-01-31C16284748780-19d75b9d0-e482-f424-e053-dadaa90a57ceTYLENOL EXTRA STRENGTH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0005-0TYLENOL EXTRA STRENGTH24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2418
50090-0005-0TYLENOL EXTRA STRENGTH1 in 1 CARTONTABLET, FILM COATED118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0005-0EA - Each50090-00056db98035-45ab-49ad-9f6e-ace0d1bba46412021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
50090-0005TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]18Current NDC, Legacy NDC, 2 package rows20240517_1b4db77f-b254-4db5-8e98-d46850140a9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0005-0500900005001 BOTTLE, PLASTIC in 1 CARTON (50090-0005-0) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2014-11-280000-00-00NoNoCurrent