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 46 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RIGHT REMEDIES LOW DOSE Aspirin 81mgASPIRINStrive Pharmaceuticals Inc.322c0e50-cf75-51ab-e063-6294a90a92352025-04-14WarningsExact identifier
application number: M013
Bayer Aspirin Regimen Chewable Low Dose Aspirin OrangeASPIRINBayer HealthCare LLC.0c6ae05f-760f-34d1-e054-00144ff88e882025-04-11WarningsExact identifier
application number: M013
Arthriten Inflammatory Pain FormulaACETAMINOPHEN, ASPIRIN, CAFFEINEKobayashi Healthcare International, Incc280ca89-4fb5-4050-90ee-d706a550a1ef2025-04-11WarningsExact identifier
application number: M013
Bayer Back and Body Extra StrengthASPIRIN,CAFFEINEBayer HealthCare LLC.0c77c484-6caf-12ca-e054-00144ff88e882025-04-10WarningsExact identifier
application number: M013
Adult Low Dose Enteric Coated AspirinASPIRINNuCare Pharmaceuticals, Inc.324937c3-c558-bc79-e063-6294a90acc8e2025-04-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHEN 500MGCVS Pharmacy, Inc.1fde6487-6682-99a3-e063-6294a90a36702025-04-04WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENBryant Ranch Prepackbdc466c9-d9ae-4293-b7ea-46fb517661c62025-04-01WarningsExact identifier
application number: M013
Adult Low Dose Enteric Coated AspirinASPIRINGeri-Care Pharmaceutical Corpe327a52a-0e31-44b7-9823-7f60d070ae522025-04-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENProficient Rx LP9af5ccc8-aac0-4339-a9f6-58fdc9b91c572025-04-01WarningsExact identifier
application number: M013
ASPIRIN 325 MG ECASPIRINBryant Ranch Prepack9d0449d2-c0c6-4e74-931b-35dc625840282025-03-31WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINBryant Ranch Prepackcce1e8bd-63c8-403a-bc32-e6788493f6042025-03-31WarningsExact identifier
application number: M013
Adwe Feverx Acetaminophen Caplets, 500 mg Extra StrengthACETAMINOPHENAurex Laboratories Limited Liability Company948c5826-6f35-484d-bb3f-cecf6a4b5c132025-03-31WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENWALGREENS281a530b-c759-50eb-e063-6394a90abb4f2025-03-28WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWR Group, Inc.8281771c-485c-42a9-9a1c-9a7a4298c5b82025-03-28WarningsExact identifier
application number: M013
Acetaminophen Regular strengthACETAMINOPHENPD-Rx Pharmaceuticals, Inc.4181efc2-d183-410c-b647-233444c57e322025-03-20WarningsExact identifier
application number: M013
CounterAct PainACETAMINOPHENMelaleuca, Inc.7faf76b4-7f25-377d-e053-2a91aa0a19d42025-03-20Boxed warning, WarningsExact identifier
application number: M013
MejoralACETAMINOPHEN, CAFFEINEOPMX LLC0bccf571-fcb9-2dd5-e063-6294a90a5f162025-03-19WarningsExact identifier
application number: M013
ARTRIFIN 24 CAPLETSACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLCe7f15c2b-a730-b54f-e053-2a95a90a3b3e2025-03-19WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLTARGET Corporation1fc3806e-a5c4-4a6e-951b-dfbf9f5771f12025-03-17WarningsExact identifier
application number: M013
Signature Select Effervescent Pain ReliefASPIRINSafeway Inc.304fca65-2867-c963-e063-6394a90a183f2025-03-14WarningsExact 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