FDA.reportPublic FDA data

TYLENOL Extra Strength

Product NDC
50580-457
11-digit product format
505800457
Labeler code
50580
Product ID
50580-457_2ddb1260-fde6-1914-e063-6394a90a82d7
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
2020-07-10
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
c830320e-72ba-48ff-a4cd-250ac5650bf0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-457-10TYLENOL Extra Strength100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1009
50580-457-10TYLENOL Extra Strength1 in 1 CARTONTABLET, FILM COATED19
50580-457-11TYLENOL Extra Strength10 in 1 BLISTER PACKTABLET, FILM COATED109
50580-457-11TYLENOL Extra Strength10 in 1 CARTONTABLET, FILM COATED109
50580-457-70TYLENOL Extra Strength700 in 1 BOTTLE, PLASTICTABLET, FILM COATED7009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-457-11EA - Each50580-457c86e83a8-18ef-42d7-80bf-c165e09112fd12021-02-05
50580-457-70EA - Each50580-4575487d689-2225-4f7d-a25b-71326b8c986b12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-457TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [KENVUE BRANDS LLC]9Current NDC, Legacy NDC, 5 package rows20250221_c830320e-72ba-48ff-a4cd-250ac5650bf0.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 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique at Home APAP Extra StrengthACETAMINOPHEN 500 MGUnifirst First Aid Corporationb56b4110-fb8f-e5a0-e053-2995a90a0ad32025-09-08WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENP & L Development, LLC64c642b7-ef83-44b7-a014-6fa248dff3ba2025-09-08WarningsExact identifier
application number: M013
Extra Strength Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINEBJWC (Berkley & Jensen / BJ's)2f473f1f-7cf3-2af5-e063-6394a90aaa172025-09-01WarningsExact identifier
application number: M013
foster and thrive rapid release pain reliefACETAMINOPHENStrategic Sourcing Services LLCd2130173-b107-4ae6-a1f7-6db467da38202025-08-30WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.e1d4f562-433c-4344-9b77-1a7c731d1be52025-08-29WarningsExact identifier
application number: M013
Aspirin Enteric Coated Low DoseASPIRINWalgreen Companyb11a4c4e-374c-403e-a757-5e9700f9f03b2025-08-27WarningsExact identifier
application number: M013
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNc830320e-72ba-48ff-a4cd-250ac5650bf09
209459Tylenol Extra Strength 500 MG Oral TabletPSNc830320e-72ba-48ff-a4cd-250ac5650bf09
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBDc830320e-72ba-48ff-a4cd-250ac5650bf09
198440acetaminophen 500 MG Oral TabletSCDc830320e-72ba-48ff-a4cd-250ac5650bf09
198440APAP 500 MG Oral TabletSYc830320e-72ba-48ff-a4cd-250ac5650bf09
209459APAP 500 MG Oral Tablet [Tylenol]SYc830320e-72ba-48ff-a4cd-250ac5650bf09
209459Tylenol 500 MG Oral TabletSYc830320e-72ba-48ff-a4cd-250ac5650bf09
209459Tylenol Extra Strength 500 MG Oral TabletSYc830320e-72ba-48ff-a4cd-250ac5650bf09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-457-10505800457101 BOTTLE, PLASTIC in 1 CARTON (50580-457-10) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2020-07-100000-00-00NoNoCurrent
50580-457-115058004571110 BLISTER PACK in 1 CARTON (50580-457-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2020-07-170000-00-00NoNoCurrent
50580-457-7050580045770700 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-457-70) 2020-07-170000-00-00NoNoCurrent