FDA.reportPublic FDA data

Aurophen Extra Strength for Adults

Product NDC
58602-755
11-digit product format
586020755
Labeler code
58602
Product ID
58602-755_0b45d2e0-f876-1f31-e063-6294a90aa24f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Aurohealth LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-02-26
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
Aurophen Extra Strength for Adults
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198440Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a769094b-1e91-4ca7-ba67-21aa7e312910Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-755-07Aurophen Extra Strength for Adults1 in 1 CARTONTABLET16
58602-755-07Aurophen Extra Strength for Adults24 in 1 BOTTLETABLET246
58602-755-12Aurophen Extra Strength for Adults1 in 1 CARTONTABLET16
58602-755-12Aurophen Extra Strength for Adults40 in 1 BOTTLETABLET406
58602-755-14Aurophen Extra Strength for Adults50 in 1 BOTTLETABLET506
58602-755-14Aurophen Extra Strength for Adults1 in 1 CARTONTABLET16
58602-755-21Aurophen Extra Strength for Adults100 in 1 BOTTLETABLET1006
58602-755-21Aurophen Extra Strength for Adults1 in 1 CARTONTABLET16
58602-755-29Aurophen Extra Strength for Adults150 in 1 BOTTLETABLET1506
58602-755-34Aurophen Extra Strength for Adults200 in 1 BOTTLETABLET2006
58602-755-35Aurophen Extra Strength for Adults225 in 1 BOTTLETABLET2256
58602-755-36Aurophen Extra Strength for Adults250 in 1 BOTTLETABLET2506
58602-755-40Aurophen Extra Strength for Adults500 in 1 BOTTLETABLET5006
58602-755-41Aurophen Extra Strength for Adults1000 in 1 BOTTLETABLET10006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-755AUROPHEN EXTRA STRENGTH FOR ADULTS (ACETAMINOPHEN) TABLET [AUROHEALTH LLC]6Current NDC, Legacy NDC, 14 package rows20231130_a769094b-1e91-4ca7-ba67-21aa7e312910.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 TabletPSNa769094b-1e91-4ca7-ba67-21aa7e3129106
198440acetaminophen 500 MG Oral TabletSCDa769094b-1e91-4ca7-ba67-21aa7e3129106
198440APAP 500 MG Oral TabletSYa769094b-1e91-4ca7-ba67-21aa7e3129106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-755-07586020755071 BOTTLE in 1 CARTON (58602-755-07) / 24 TABLET in 1 BOTTLE1 bottle2016-02-260000-00-00NoNoCurrent
58602-755-12586020755121 BOTTLE in 1 CARTON (58602-755-12) / 40 TABLET in 1 BOTTLE1 bottle2016-02-260000-00-00NoNoCurrent
58602-755-14586020755141 BOTTLE in 1 CARTON (58602-755-14) / 50 TABLET in 1 BOTTLE1 bottle2016-02-260000-00-00NoNoCurrent
58602-755-21586020755211 BOTTLE in 1 CARTON (58602-755-21) / 100 TABLET in 1 BOTTLE1 bottle2016-02-260000-00-00NoNoCurrent
58602-755-2958602075529150 TABLET in 1 BOTTLE (58602-755-29) 150 tablet2016-02-260000-00-00NoNoCurrent
58602-755-3458602075534200 TABLET in 1 BOTTLE (58602-755-34) 200 tablet2016-02-260000-00-00NoNoCurrent
58602-755-3558602075535225 TABLET in 1 BOTTLE (58602-755-35) 225 tablet2016-02-260000-00-00NoNoCurrent
58602-755-3658602075536250 TABLET in 1 BOTTLE (58602-755-36) 250 tablet2020-04-130000-00-00NoNoCurrent
58602-755-4058602075540500 TABLET in 1 BOTTLE (58602-755-40) 500 tablet2016-02-260000-00-00NoNoCurrent
58602-755-41586020755411000 TABLET in 1 BOTTLE (58602-755-41) 1000 tablet2020-08-140000-00-00NoNoCurrent