Acetaminophen Extra Strength

Product NDC
58602-745
11-digit product format
586020745
Labeler code
58602
Product ID
58602-745_0b44d6cf-d21e-741a-e063-6294a90a05ff
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Aurohealth LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-07
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
Acetaminophen 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bc03fa56-8880-4bbd-81a0-91853fecdd4eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-745-07Acetaminophen Extra Strength24 in 1 BOTTLETABLET242
58602-745-07Acetaminophen Extra Strength1 in 1 CARTONTABLET12
58602-745-14Acetaminophen Extra Strength50 in 1 BOTTLETABLET502
58602-745-14Acetaminophen Extra Strength1 in 1 CARTONTABLET12
58602-745-21Acetaminophen Extra Strength100 in 1 BOTTLETABLET1002
58602-745-21Acetaminophen Extra Strength1 in 1 CARTONTABLET12
58602-745-35Acetaminophen Extra Strength225 in 1 BOTTLETABLET2252
58602-745-35Acetaminophen Extra Strength1 in 1 CARTONTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-745ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [AUROHEALTH LLC]2Current NDC, Legacy NDC, 8 package rows20231130_bc03fa56-8880-4bbd-81a0-91853fecdd4e.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 70 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN, AND CAFFEINEJHK Inc dba American Safety & First Aid87c5ad71-0448-4e0f-acee-bf9a1d38675e2024-04-25WarningsExact identifier
application number: M013
dg health childrens pain and feverACETAMINOPHENDolgencorp Inc49b2ac72-86a3-4783-bf51-8c1a222e457e2024-04-25WarningsExact identifier
application number: M013
basic care infants pain and feverACETAMINOPHENAmazon.com Services LLCdab1f9e6-3875-4d53-a417-c6a78274ee562024-04-23WarningsExact identifier
application number: M013
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLCa71074a6-cc19-4bb3-8c84-4e82a89068012024-04-22WarningsExact identifier
application number: M013
Regular Strength AcetaminophenACETAMINOPHENKROGER COMPANY0fe995cd-f974-db04-e063-6294a90a33552024-04-18WarningsExact identifier
application number: M013
Regular Strength Aspirin 325 mgASPIRINKroger0fc3193d-af4e-ff3a-e063-6294a90a27432024-04-17WarningsExact identifier
application number: M013
Childrens Pain and Fever Dye FreeACETAMINOPHENKROGER COMPANY0fec66b4-3a2a-63d1-e063-6294a90a6d722024-04-17WarningsExact identifier
application number: M013
aspirin low dose chewableASPIRINTime-Cap Labs, Inc5d56618c-8ea2-42ea-a9f2-339bd0055ddd2024-04-17WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINP & L Development, LLC0058175f-3474-40c3-a046-6cfaec86d84b2024-04-16WarningsExact identifier
application number: M013
Handy Solutions Headache Pain ReliefACETAMINOPHEN, ASPIRIN, CAFFEINENavajo Manufacturing Company Inc.e5481abe-6971-2bc5-e053-2995a90ae8952024-04-15WarningsExact identifier
application number: M013
childrens acetaminophenACETAMINOPHENMajor Pharmaceuticals243a5cff-e506-434b-ab19-1a6ac53f85332024-04-15WarningsExact identifier
application number: M013
Dye Free Pain Reliever ChildrensACETAMINOPHENP & L Development, LLC45ddcaad-d416-4d7c-a84a-43548d5c5d3b2024-04-15WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENNavajo Manufacturing Company Inc.65bf1556-f25a-9439-e053-2a91aa0a31942024-04-15WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENKroger Companybbeebdd6-fe2c-5b8a-e053-2a95a90ab95e2024-04-13WarningsExact identifier
application number: M013
infants pain reliefACETAMINOPHENPublix Super Markets Inc3d1818a7-d3b2-434c-b3c9-b2713f08ded22024-04-13WarningsExact identifier
application number: M013
Mommys Bliss Childrens Pain and FeverACETAMINOPHENMom Enterprises, LLC.08b9eaf7-70d1-640f-e063-6394a90a8d3b2024-04-12WarningsExact identifier
application number: M013
Mommys Bliss Infants Pain and FeverACETAMINOPHENMom Enterprises, LLC.05e26650-81b3-d7b1-e063-6394a90a14ed2024-04-11WarningsExact identifier
application number: M013
Childrens Pain ReliefCHILDRENS PAIN RELIEFAllegiant Health7381dd26-c507-4d02-b989-cfd96e02f4952024-04-11WarningsExact identifier
application number: M013
Childrens Pain Relief Dye-FreeACTEAMINOPHENWinCo Foods, LLC5ee134b3-b8e9-4621-b0a1-a84d9867ccba2024-04-11WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENWALGREENS0b1d086f-7be1-5072-e063-6394a90a11e62024-04-10WarningsExact identifier
application number: M013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-745-07586020745071 BOTTLE in 1 CARTON (58602-745-07) / 24 TABLET in 1 BOTTLE1 bottle2021-01-070000-00-00NoNoCurrent
58602-745-14586020745141 BOTTLE in 1 CARTON (58602-745-14) / 50 TABLET in 1 BOTTLE1 bottle2021-01-070000-00-00NoNoCurrent
58602-745-21586020745211 BOTTLE in 1 CARTON (58602-745-21) / 100 TABLET in 1 BOTTLE1 bottle2021-01-070000-00-00NoNoCurrent
58602-745-35586020745351 BOTTLE in 1 CARTON (58602-745-35) / 225 TABLET in 1 BOTTLE1 bottle2021-01-070000-00-00NoNoCurrent