FDA.reportPublic FDA data

Tylenol Extra Strength

Product NDC
67414-449
11-digit product format
674140449
Labeler code
67414
Product ID
67414-449_39845b60-16e5-ee53-e063-6294a90af9d7
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
Jones Healthcare Group - Packaging Services, Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-24
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
Brand name suffix
Caplet
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
fba711c1-4e69-49b0-8994-97c455aebcb2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67414-449-00Tylenol Extra StrengthCaplet2500 in 1 BOXTABLET25007
67414-449-00Tylenol Extra StrengthCaplet2 in 1 POUCHTABLET27
67414-449-10Tylenol Extra StrengthCaplet2 in 1 POUCHTABLET27
67414-449-10Tylenol Extra StrengthCaplet50 in 1 BOXTABLET507
67414-449-11Tylenol Extra StrengthCaplet50 in 1 BOXTABLET507
67414-449-11Tylenol Extra StrengthCaplet2 in 1 POUCHTABLET27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67414-449TYLENOL EXTRA STRENGTH CAPLET (ACETAMINOPHEN) TABLET [JONES HEALTHCARE GROUP - PACKAGING SERVICES, INC]6Current NDC, Legacy NDC, 6 package rows20231106_fba711c1-4e69-49b0-8994-97c455aebcb2.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 73 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PANADOL ExtraACETAMINOPHEN AND CAFFEINEHaleon US Holdings LLCe5c2d88a-d903-4ca0-b895-f27e791dfc4e2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLCb2fe7f47-1a2e-40ee-8f8f-38f2028dce1b2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLC9d384e88-5c11-4600-ac6c-a383715701382024-02-06WarningsExact identifier
application number: M013
PANADOLACETAMINOPHENHaleon US Holdings LLC95801755-db54-4ad7-bec1-52671914f6ca2024-02-06WarningsExact identifier
application number: M013
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLC01e7dddb-755c-4745-b701-edcdb62090642024-02-06Warnings, Adverse reactionsExact identifier
application number: M013
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLCfe7cd1f2-9b00-4ded-99c2-8a152c71093c2024-02-06Warnings, Adverse reactionsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAptaPharma Inc.9064943f-836f-4853-b6f2-2c4879941eeb2024-02-02WarningsExact identifier
application number: M013
Quality Choice Effervescent Pain ReliefASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.079af5d7-1be8-2a93-e063-6294a90a496d2024-02-01WarningsExact identifier
application number: M013
MEDI-FIRST Non-AspirinACETAMINOPHENProficient Rx LP4c84948d-3a95-4c53-8529-7e7b9d8bb6df2024-02-01WarningsExact identifier
application number: M013
PharbetolACETAMINOPHENProficient Rx LP9c7d65e4-df2f-47c1-a185-66aaf19aad2b2024-02-01WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENProficient Rx LP57e4820c-b4eb-442e-9c49-93eedfbc5e5e2024-02-01WarningsExact identifier
application number: M013
good sense aspirinASPIRINProficient Rx LP73013074-9c6e-43c7-acde-4d9d8ed0133d2024-02-01WarningsExact identifier
application number: M013
MEDIQUE APAP Extra StrengthACETAMINOPHENProficient Rx LPc466a07f-2339-4cf5-8377-e0f109649c522024-02-01WarningsExact identifier
application number: M013
Percogesic Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINEMedtech Products Inc.2c5f1140-fb83-42c9-b0b1-5e2bd69340bb2024-02-01WarningsExact identifier
application number: M013
aspirinASPIRINProficient Rx LP3c7783a7-2b28-4968-b766-0a49dc70ce6d2024-02-01WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENNuCare Pharmaceuticals,Inc.102bdcde-cb90-f248-e063-6394a90aac792024-01-30WarningsExact identifier
application number: M013
Excedrin Extra Strength HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINEHaleon US Holdings LLC61802b27-c9ec-4386-9d44-45e8b1e558b72024-01-28WarningsExact identifier
application number: M013
AGRIFENACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLC0fde22da-cdfc-36cc-e063-6294a90a38852024-01-26WarningsExact identifier
application number: M013
DOLODOLACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLCe80536f1-92cc-5bb3-e053-2995a90a95402024-01-26WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINBryant Ranch Prepackd913d11f-c7a1-49d2-a2d3-9a29fc0328062024-01-18WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNfba711c1-4e69-49b0-8994-97c455aebcb27
209459Tylenol Extra Strength 500 MG Oral TabletPSNfba711c1-4e69-49b0-8994-97c455aebcb27
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBDfba711c1-4e69-49b0-8994-97c455aebcb27
198440acetaminophen 500 MG Oral TabletSCDfba711c1-4e69-49b0-8994-97c455aebcb27
198440APAP 500 MG Oral TabletSYfba711c1-4e69-49b0-8994-97c455aebcb27
209459APAP 500 MG Oral Tablet [Tylenol]SYfba711c1-4e69-49b0-8994-97c455aebcb27
209459Tylenol 500 MG Oral TabletSYfba711c1-4e69-49b0-8994-97c455aebcb27
209459Tylenol Extra Strength 500 MG Oral TabletSYfba711c1-4e69-49b0-8994-97c455aebcb27
198440acetaminophen 500 MG Oral TabletPSN99e45e83-37a3-44df-9a2a-98ba7457a5bb4
209459Tylenol Extra Strength 500 MG Oral TabletPSN99e45e83-37a3-44df-9a2a-98ba7457a5bb4
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD99e45e83-37a3-44df-9a2a-98ba7457a5bb4
198440acetaminophen 500 MG Oral TabletSCD99e45e83-37a3-44df-9a2a-98ba7457a5bb4
198440APAP 500 MG Oral TabletSY99e45e83-37a3-44df-9a2a-98ba7457a5bb4
209459APAP 500 MG Oral Tablet [Tylenol]SY99e45e83-37a3-44df-9a2a-98ba7457a5bb4
209459Tylenol 500 MG Oral TabletSY99e45e83-37a3-44df-9a2a-98ba7457a5bb4
209459Tylenol Extra Strength 500 MG Oral TabletSY99e45e83-37a3-44df-9a2a-98ba7457a5bb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67414-449-00674140449002500 POUCH in 1 BOX (67414-449-00) / 2 TABLET in 1 POUCH2500 pouch2018-01-240000-00-00NoNoCurrent
67414-449-106741404491050 POUCH in 1 BOX (67414-449-10) / 2 TABLET in 1 POUCH50 pouch2018-01-240000-00-00NoNoCurrent
67414-449-116741404491150 POUCH in 1 BOX (67414-449-11) / 2 TABLET in 1 POUCH50 pouch2018-01-240000-00-00NoNoCurrent