FDA.reportPublic FDA data

TYLENOL Extra Strength

Product NDC
50580-209
11-digit product format
505800209
Labeler code
50580
Product ID
50580-209_3efe12ef-7f94-9548-e063-6294a90aba91
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
POWDER
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-15
Substance
ACETAMINOPHEN
Active strength
500 mg/.95g
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/.95g

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
2374360Internal RxNorm lookup
2374361Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ab02080a-c903-4e4a-a9f3-2b8197ed2f2bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-209-02TYLENOL Extra Strength12 in 1 CARTONPOWDER127
50580-209-02TYLENOL Extra Strength0.95 g in 1 PACKETPOWDER0.957
50580-209-04TYLENOL Extra Strength32 in 1 CARTONPOWDER327
50580-209-04TYLENOL Extra Strength0.95 g in 1 PACKETPOWDER0.957

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-209-02EA - Each50580-209efe66416-47ae-407a-92a8-7561b45e7a3112022-07-06
50580-209-04EA - Each50580-2092a4b1688-45e3-456c-90cf-9e36a2d011c212022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-209TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) POWDER [KENVUE BRANDS LLC]6Current NDC, Legacy NDC, 4 package rows20241103_ab02080a-c903-4e4a-a9f3-2b8197ed2f2b.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 17 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AspirinASPIRINCardinal Health 110, LLC. DBA Leader318cc982-23a9-4804-b6fb-248f772d7a382026-04-02WarningsExact identifier
application number: M013
Chewable Acetaminophen ChildrensACETAMINOPHENCardinal Health 110, LLC. DBA Leader8a18565c-b84e-43f8-8e96-e1dbcc39f08b2026-04-02WarningsExact identifier
application number: M013
Childrens Pain RelieverACETAMINOPHENH E Bc713556c-cb9e-4ed2-bc2f-49b3d6256c0f2026-04-02WarningsExact identifier
application number: M013
AspirinASPIRINDiscount Drug Mart4a1e9c79-5036-4c69-82f9-e48abc972b472026-04-02WarningsExact identifier
application number: M013
WispirinASPIRINWisdrug AG4e70ec5e-d033-a525-e063-6394a90a5a932026-04-01WarningsExact identifier
application number: M013
Aspirin RegimenASPIRINCardinal Health 110, LLC. DBA Leaderef2d75ee-9ed7-4b53-adbc-2ec40364da632026-03-31WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINEHi-Tech Nutraceuticals, LLCb119ba37-0ee3-851a-e053-2995a90a85b12026-03-31WarningsExact identifier
application number: M013
AspirinASPIRINRMT HEALTH LLC4dc7229d-c895-1f80-e063-6394a90abfc32026-03-30WarningsExact identifier
application number: M013
AspirinASPIRINPD-Rx Pharmaceuticals, Inc.d1f05e56-c830-4f85-b685-2a5965d10a1c2026-03-26WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENBryant Ranch Prepackad01aea6-4af3-469b-b99d-e1e66aa40e8d2026-03-25WarningsExact identifier
application number: M013
aspirinASPIRINMeijer Distribution Incc550b92e-de54-4599-9534-bd3022b0a86d2026-03-25WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINAmerisourceBergen (Good Neighbor Pharmacy) 46122db187226-0770-4934-90a4-c6ca50bdecef2026-03-25WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)804d4b63-1bbe-47c0-ad49-39ddbeade6a32026-03-25WarningsExact identifier
application number: M013
childrens pain and feverACETAMINOPHENHyVee Inc9d9c2bf6-8660-4987-8794-936d3102da8d2026-03-24WarningsExact identifier
application number: M013
Childrens Pain RelieverACETAMINOPHENBJWC (Berkley & Jensen / BJ's)851228ea-eaf3-452b-a9ce-8cd244a0eaf32026-03-24WarningsExact identifier
application number: M013
FirstCare Childrens Pain Fever AcetaminophenACETAMINOPHEN 80 MGUSpharma Ltd9fc05ba6-5667-457e-82c1-a8b4e16cadda2026-03-23WarningsExact identifier
application number: M013
AspirinASPIRINAarkish Pharmaceuticals NJ Inc.e5e9e1ce-666a-461f-8287-a4642902067c2026-03-23WarningsExact identifier
application number: M013
Chewable Aspirin Low DoseCHEWABLE ASPIRINGrocery Outlet609c0389-8bed-4483-84fa-73ee73fdb4e42026-03-20WarningsExact identifier
application number: M013
Adult Low Dose Pain RelieverASPIRINTWIN MED LLCa395acf4-f487-4c98-8c44-ca2aaaf72deb2026-03-20WarningsExact identifier
application number: M013
RapidolACETAMINOPHENPharmadel LLC3a210860-1fc1-e496-e063-6394a90a87052026-03-20WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2374360acetaminophen 500 MG Oral PowderPSNab02080a-c903-4e4a-a9f3-2b8197ed2f2b7
2374361Tylenol DISSOLVE PACKS 500 MG Oral PowderPSNab02080a-c903-4e4a-a9f3-2b8197ed2f2b7
2374361acetaminophen 500 MG Oral Powder [Tylenol]SBDab02080a-c903-4e4a-a9f3-2b8197ed2f2b7
2374360acetaminophen 500 MG Oral PowderSCDab02080a-c903-4e4a-a9f3-2b8197ed2f2b7
2374360APAP 500 MG Oral PowderSYab02080a-c903-4e4a-a9f3-2b8197ed2f2b7
2374361APAP 500 MG Oral Powder [Tylenol]SYab02080a-c903-4e4a-a9f3-2b8197ed2f2b7
2374361Tylenol 500 MG Oral PowderSYab02080a-c903-4e4a-a9f3-2b8197ed2f2b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-209-025058002090212 PACKET in 1 CARTON (50580-209-02) / .95 g in 1 PACKET12 packet2020-06-150000-00-00NoNoCurrent
50580-209-045058002090432 PACKET in 1 CARTON (50580-209-04) / .95 g in 1 PACKET32 packet2020-06-150000-00-00NoNoCurrent