FDA.reportPublic FDA data

Tylenol Extra Strength

Product NDC
50580-378
11-digit product format
505800378
Labeler code
50580
Product ID
50580-378_48dff3c9-329f-1300-e063-6294a90a47ef
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
2014-11-01
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
17cfa99d-abb2-4d77-9e0e-e77109fbb61aAvailable on FDA.report

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, Related label table
NDCEffectiveRelated label
50580-378-012024-02-01Tylenol ® Extra Strength
50580-378-012024-02-01Tylenol ® Extra Strength
50580-378-022024-02-01Tylenol ® Extra Strength
50580-378-022024-02-01Tylenol ® Extra Strength
50580-378-032024-02-01Tylenol ® Extra Strength
50580-378-032024-02-01Tylenol ® Extra Strength
50580-378-042024-02-01Tylenol ® Extra Strength
50580-378-042024-02-01Tylenol ® Extra Strength
50580-378-052024-02-01Tylenol ® Extra Strength
50580-378-052024-02-01Tylenol ® Extra Strength
50580-378-062024-02-01Tylenol ® Extra Strength
50580-378-062024-02-01Tylenol ® Extra Strength
50580-378-072024-02-01Tylenol ® Extra Strength
50580-378-072024-02-01Tylenol ® Extra Strength
50580-378-082024-02-01Tylenol ® Extra Strength
50580-378-082024-02-01Tylenol ® Extra Strength
50580-378-012024-01-30Tylenol ® Extra Strength
50580-378-012024-01-30Tylenol ® Extra Strength
50580-378-022024-01-30Tylenol ® Extra Strength
50580-378-022024-01-30Tylenol ® Extra Strength
50580-378-032024-01-30Tylenol ® Extra Strength
50580-378-032024-01-30Tylenol ® Extra Strength
50580-378-042024-01-30Tylenol ® Extra Strength
50580-378-042024-01-30Tylenol ® Extra Strength
50580-378-052024-01-30Tylenol ® Extra Strength
50580-378-052024-01-30Tylenol ® Extra Strength
50580-378-062024-01-30Tylenol ® Extra Strength
50580-378-062024-01-30Tylenol ® Extra Strength
50580-378-072024-01-30Tylenol ® Extra Strength
50580-378-072024-01-30Tylenol ® Extra Strength
50580-378-082024-01-30Tylenol ® Extra Strength
50580-378-082024-01-30Tylenol ® Extra Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-378-01Tylenol Extra Strength24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2416
50580-378-01Tylenol Extra Strength1 in 1 CARTONTABLET, FILM COATED116
50580-378-02Tylenol Extra Strength100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10016
50580-378-02Tylenol Extra Strength1 in 1 CARTONTABLET, FILM COATED116
50580-378-03Tylenol Extra Strength225 in 1 BOTTLE, PLASTICTABLET, FILM COATED22516
50580-378-04Tylenol Extra Strength1 in 1 CARTONTABLET, FILM COATED116
50580-378-04Tylenol Extra Strength24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2416
50580-378-05Tylenol Extra Strength50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5016
50580-378-05Tylenol Extra Strength1 in 1 CARTONTABLET, FILM COATED116
50580-378-06Tylenol Extra Strength100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10016
50580-378-06Tylenol Extra Strength1 in 1 CARTONTABLET, FILM COATED116
50580-378-07Tylenol Extra Strength1 in 1 CARTONTABLET, FILM COATED116
50580-378-07Tylenol Extra Strength225 in 1 BOTTLE, PLASTICTABLET, FILM COATED22516
50580-378-08Tylenol Extra Strength325 in 1 BOTTLE, PLASTICTABLET, FILM COATED32516
50580-378-37Tylenol Extra Strength320 in 1 BOTTLETABLET, FILM COATED32016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-378-02EA - Each50580-378c823b137-4e5c-42cc-8af6-1224282ef2cd12017-04-05
50580-378-37EA - Each50580-378e15f0786-655c-4c38-822f-8ac42483357012026-04-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
AcetaminophenACTIVE MOIETY362O9ITL9DTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
aluminum oxideINACTIVE INGREDIENTLMI26O6933TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
crospovidoneINACTIVE INGREDIENT68401960MKTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOATYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ATYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
povidonesINACTIVE INGREDIENTFZ989GH94ETYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
shellacINACTIVE INGREDIENT46N107B71OTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-378TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [KENVUE BRANDS LLC]14Current NDC, Legacy NDC, 15 package rows20250221_17cfa99d-abb2-4d77-9e0e-e77109fbb61a.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 61 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chewable AspirinASPIRINRETAIL BUSINESS SERVICES , LLC.c94d68ea-7f25-881f-e053-2995a90aa47f2024-10-15WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINRETAIL BUSINESS SERVICES , LLC.c94d750e-5a85-77f5-e053-2995a90a69152024-10-15WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENWalgreen Company9e08eb38-7538-4fa0-a0e1-047ab6cb16802024-10-15WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENPUBLIX SUPER MARKETS INC9e779cc6-4641-6132-e053-2a95a90a34932024-10-11WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENCHAIN DRUG CONSORTIUM5c1a3081-ae25-4895-bf76-ebcbb9fc80722024-10-11WarningsExact identifier
application number: M013
Aspirin 81 MGASPIRINMeijerb3e5711c-9529-4eec-871d-de8efa858b862024-10-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMEIJER DISTRIBUTION INC9586e830-a285-4a07-8b34-9698754423482024-10-11WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENChain Drug Marketing Association68a52858-35c5-402a-8ceb-8d8a7c1e5f6c2024-10-11WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENChain Drug Marketing Association5de40821-3218-4320-bf11-9493bf01d4892024-10-11WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association475becec-1a56-4cfa-a0c5-562f8772adfb2024-10-11WarningsExact identifier
application number: M013
Topcare Pain ReliefACETAMINOPHENTopco Associates LLC6036c15b-1168-4103-9471-6a74a2140e532024-10-10WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma46d9d8cd-e3db-492c-9386-7e8255beff642024-10-08WarningsExact identifier
application number: M013
dg health aspirinASPIRINDolgencorp, LLC0ab34dc7-0110-4fc3-ae53-234e7d7bca3c2024-10-07WarningsExact identifier
application number: M013
ValuMeds Pain Relief PM Pain Reliever and Nighttime Sleep Aid Acetaminophen, Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.19ba1fb6-22ea-488e-9e52-94c14ceb80d12024-10-07WarningsExact identifier
application number: M013
foster and thrive aspirinASPIRINStrategic Sourcing Services LLC4d66a8a8-a1c1-4430-8845-21ae67700c392024-10-07WarningsExact identifier
application number: M013
leader aspirinASPIRINCardinal Health 110, LLC. dba Leaderca603b12-e0f7-4d79-8e0d-4651a788ba9b2024-10-07WarningsExact identifier
application number: M013
foster and thrive aspirinASPIRINMcKesson Medical-Surgical, Inc.e9342478-93d6-45de-948f-f4162ee675b22024-10-07WarningsExact identifier
application number: M013
Maximum Strength Backache ReliefMAGNESIUM SALICYLATEJHK DBA American Safety & First Aidf8cbcd4e-cfad-4592-8774-52e681494c452024-10-07WarningsExact identifier
application number: M013
Alka-Seltzer Original FlavorALKA-SELTZER ORIGINAL FLAVORNavajo Manufacturing Company Inc.f70875ab-241c-4876-e053-6294a90a80922024-10-03WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENNavajo Manufacturing Company Inc.86b6ac01-3866-4cd8-a1be-9babb6ff311b2024-10-02WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN17cfa99d-abb2-4d77-9e0e-e77109fbb61a16
209459Tylenol Extra Strength 500 MG Oral TabletPSN17cfa99d-abb2-4d77-9e0e-e77109fbb61a16
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD17cfa99d-abb2-4d77-9e0e-e77109fbb61a16
198440acetaminophen 500 MG Oral TabletSCD17cfa99d-abb2-4d77-9e0e-e77109fbb61a16
198440APAP 500 MG Oral TabletSY17cfa99d-abb2-4d77-9e0e-e77109fbb61a16
209459APAP 500 MG Oral Tablet [Tylenol]SY17cfa99d-abb2-4d77-9e0e-e77109fbb61a16
209459Tylenol 500 MG Oral TabletSY17cfa99d-abb2-4d77-9e0e-e77109fbb61a16
209459Tylenol Extra Strength 500 MG Oral TabletSY17cfa99d-abb2-4d77-9e0e-e77109fbb61a16
198440acetaminophen 500 MG Oral TabletPSN85294a70-3233-4ba5-bc36-ee3f2964aebf15
209459Tylenol Extra Strength 500 MG Oral TabletPSN85294a70-3233-4ba5-bc36-ee3f2964aebf15
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD85294a70-3233-4ba5-bc36-ee3f2964aebf15
198440acetaminophen 500 MG Oral TabletSCD85294a70-3233-4ba5-bc36-ee3f2964aebf15
198440APAP 500 MG Oral TabletSY85294a70-3233-4ba5-bc36-ee3f2964aebf15
209459APAP 500 MG Oral Tablet [Tylenol]SY85294a70-3233-4ba5-bc36-ee3f2964aebf15
209459Tylenol 500 MG Oral TabletSY85294a70-3233-4ba5-bc36-ee3f2964aebf15
209459Tylenol Extra Strength 500 MG Oral TabletSY85294a70-3233-4ba5-bc36-ee3f2964aebf15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50580-378-01505800378011 BOTTLE, PLASTIC in 1 CARTON (50580-378-01) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2014-11-010000-00-00NoNoCurrent
50580-378-02505800378021 BOTTLE, PLASTIC in 1 CARTON (50580-378-02) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2014-11-010000-00-00NoNoCurrent
50580-378-0350580037803225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-378-03) 2015-04-060000-00-00NoNoCurrent
50580-378-04505800378041 BOTTLE, PLASTIC in 1 CARTON (50580-378-04) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2021-03-010000-00-00NoNoCurrent
50580-378-05505800378051 BOTTLE, PLASTIC in 1 CARTON (50580-378-05) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2021-03-010000-00-00NoNoCurrent
50580-378-06505800378061 BOTTLE, PLASTIC in 1 CARTON (50580-378-06) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2021-03-010000-00-00NoNoCurrent
50580-378-07505800378071 BOTTLE, PLASTIC in 1 CARTON (50580-378-07) / 225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2021-03-010000-00-00NoNoCurrent
50580-378-0850580037808325 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-378-08) 2021-03-010000-00-00NoNoCurrent
50580-378-3750580037837320 TABLET, FILM COATED in 1 BOTTLE (50580-378-37) 2026-03-31NoNoCurrent