FDA.reportPublic FDA data

TYLENOL EXTRA STRENGTH

Product NDC
50090-5469
11-digit product format
500905469
Labeler code
50090
Product ID
50090-5469_72fb757a-ac68-4800-bdc0-ace18841ef75
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
2019-08-19
Substance
ACETAMINOPHEN
Active strength
500 mg/1
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/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
bcb7eb24-16cb-439e-879f-48d2f5e8ba83Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5469-02023-02-07C16284748780-1f386c649-cc6a-0266-e053-dadaa90a7c1aTYLENOL EXTRA STRENGTH
50090-5469-02023-01-30C16284748780-1f386c649-cc6a-0266-e053-dadaa90a7c1aTYLENOL EXTRA STRENGTH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5469-0TYLENOL EXTRA STRENGTH1 in 1 CARTONTABLET, FILM COATED19
50090-5469-0TYLENOL EXTRA STRENGTH24 in 1 BOTTLETABLET, FILM COATED249

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5469-0EA - Each50090-54697b30bff9-74b0-41cf-864d-4b5f3b52a01212024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5469TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20240518_bcb7eb24-16cb-439e-879f-48d2f5e8ba83.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 40 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pain reliefACETAMINOPHENSafeway0e0a73f9-8c18-41fd-812e-8be20287e77a2025-08-26WarningsExact identifier
application number: M013
Aspirin Low Dose Safety CoatedASPIRINBJWC (Berkley & Jensen / BJ's)577035a5-88ab-431c-8598-7a19dd633fe92025-08-26WarningsExact identifier
application number: M013
Topcare Pain ReliefACETAMINOPHENSixarp, LLC2e20be17-2b6c-1a07-e063-6394a90acdd32025-08-25WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINBJWC (Berkley & Jensen / BJ's)2f32b096-d29a-c7c7-e063-6294a90a2bbe2025-08-22WarningsExact identifier
application number: M013
Medique Medi SeltzerASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnifirst First Aid Corporation528da9d9-2a52-4c16-b7b2-61b3eee1abea2025-08-19WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENPublix Super Markets Inc6b691dc1-09e4-46d3-b199-8917e42848a62025-08-19WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENP & L Development, LLC59eb14a5-40b0-4331-beb5-7166e6cdf4112025-08-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharmacaf5daea-409e-5dd2-e053-2995a90acb122025-08-18WarningsExact identifier
application number: M013
Dr Simi Pain Relief 100ACETAMINOPHENFarmacias De Similares TX LLC3c42e48d-cdb2-eb74-e063-6394a90a29402025-08-13WarningsExact identifier
application number: M013
Dr Simi Pain ReliefACETAMINOPHENFarmacias De Similares TX LLC3c477d33-a8c2-d39f-e063-6294a90ac5f02025-08-13WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINECHAIN DRUG MARKETING ASSOCIATION INC4005f8dd-3050-4590-8703-6997444e8df32025-08-13WarningsExact identifier
application number: M013
good sense headache reliefACETAMINOPHEN, ASPIRIN, CAFFEINEL. Perrigo Company4cae0580-7ee3-4f38-8d13-79c7d7615f8f2025-08-12WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC3bb7dc60-97b2-1291-e063-6294a90a26d92025-08-12WarningsExact identifier
application number: M013
Dr Simi Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEFarmacias De Similares TX LLC3c19ad99-6e0f-3116-e063-6394a90a914c2025-08-11WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENNuCare Pharmaceuticals,Inc.3c1f505d-0319-a179-e063-6294a90a0b172025-08-11WarningsExact identifier
application number: M013
AspirinASPIRINPROSTAT FIRST AID3bdb9d89-9000-69f9-e063-6294a90a0c972025-08-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENProstat First Aid3bdbea6a-3f11-9142-e063-6294a90a20ea2025-08-08WarningsExact identifier
application number: M013
Aspi-CorASPIRINL.N.K. International, Inc.9f919a48-ffd8-49fa-b6fd-ec71cc12e64b2025-08-08WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINA-S Medication Solutions8575ef9d-2eae-412a-a252-82b03f4d52752025-08-08WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions7a91b1df-8d6d-4205-9822-bc4d800555f72025-08-08WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNbcb7eb24-16cb-439e-879f-48d2f5e8ba839
209459Tylenol Extra Strength 500 MG Oral TabletPSNbcb7eb24-16cb-439e-879f-48d2f5e8ba839
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBDbcb7eb24-16cb-439e-879f-48d2f5e8ba839
198440acetaminophen 500 MG Oral TabletSCDbcb7eb24-16cb-439e-879f-48d2f5e8ba839
198440APAP 500 MG Oral TabletSYbcb7eb24-16cb-439e-879f-48d2f5e8ba839
209459APAP 500 MG Oral Tablet [Tylenol]SYbcb7eb24-16cb-439e-879f-48d2f5e8ba839
209459Tylenol 500 MG Oral TabletSYbcb7eb24-16cb-439e-879f-48d2f5e8ba839
209459Tylenol Extra Strength 500 MG Oral TabletSYbcb7eb24-16cb-439e-879f-48d2f5e8ba839

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5469-0500905469001 BOTTLE in 1 CARTON (50090-5469-0) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-02-170000-00-00NoNoCurrent