FDA.reportPublic FDA data

Aurophen Extra Strength for Adults

Product NDC
58602-771
11-digit product format
586020771
Labeler code
58602
Product ID
58602-771_0b45ad4e-d9d9-d463-e063-6294a90a195d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Aurohealth LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-21
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
d59c5f04-4bcc-4a52-a42f-e049506f00deAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-771-36Aurophen Extra Strength for Adults250 in 1 BOTTLETABLET2503
58602-771-40Aurophen Extra Strength for Adults500 in 1 BOTTLETABLET5003
58602-771-41Aurophen Extra Strength for Adults1000 in 1 BOTTLETABLET10003
58602-771-64Aurophen Extra Strength for Adults600 in 1 BOTTLETABLET6003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-771AUROPHEN EXTRA STRENGTH FOR ADULTS (ACETAMINOPHEN) TABLET [AUROHEALTH LLC]3Current NDC, Legacy NDC, 4 package rows20231130_d59c5f04-4bcc-4a52-a42f-e049506f00de.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 55 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETAMINOPHEN (RED)ACETAMINOPHENHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltda352f588-4a70-42b2-8f9c-a73a0629517d2024-11-25WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.5c42dd28-820c-4cc5-9016-11ad5e5806162024-11-25WarningsExact identifier
application number: M013
equate pain relieverACETAMINOPHENWALMART INC.4518fe82-3ba8-4e9e-a036-776df7fb8d572024-11-21WarningsExact identifier
application number: M013
Family Wellness Pain RelieverASPIRINFAMILY WELLNESS SERVICES, INC.075e19f4-1a58-aedd-e063-6294a90af7082024-11-20WarningsExact identifier
application number: M013
MejoralitoACETAMINOPHENOPMX Chula Vistafd2ecde0-296e-060f-e053-6294a90afd982024-11-15WarningsExact identifier
application number: M013
Temp XACETAMINOPHENOPMX Chula Vistafd2edc32-0351-c991-e053-6294a90ab4ce2024-11-15WarningsExact identifier
application number: M013
CVS Health Extra Strength Antacid and Pain RelieverASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATECVS Pharmacyafe9e755-18ba-305f-e053-2995a90aa8d02024-11-14WarningsExact identifier
application number: M013
Walgreens Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalgreens667418fc-a3ab-cbc7-e053-2a91aa0a20232024-11-13WarningsExact identifier
application number: M013
Up and Up Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATETarget Corporationa72eef45-b985-638a-e053-2995a90aa20a2024-11-13WarningsExact identifier
application number: M013
Signature Care Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATESafeway, Inc6e120024-475a-73af-e053-2a91aa0a42a62024-11-13Warnings, Adverse reactionsExact identifier
application number: M013
Kroger Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEKroger Company6d858b0e-a3c8-2686-e053-2991aa0acc062024-11-13WarningsExact identifier
application number: M013
TopCare Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATETopco Associates LLC639f9d57-f26a-708a-e053-2a91aa0a69622024-11-13Warnings, Adverse reactionsExact identifier
application number: M013
Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEH. E. Butt Grocery Company6418cde9-607b-4ca1-e053-2991aa0a91702024-11-13WarningsExact identifier
application number: M013
Bromo SeltzerASPIRIN, SODIUM BICARBONATE, CITRIC ACIDTower Laboratories Ltd8ff88ee1-e33e-4051-992f-24e2720c48ce2024-11-13WarningsExact identifier
application number: M013
Care One Original Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEFoodhold U.S.A.8f662c51-d2fa-6458-e053-2995a90ac6fd2024-11-13WarningsExact identifier
application number: M013
Top Value Effervescent Pain ReliefAPIRIN, CITRIC ACID, SODIUM BICARBONATETower Laboratories Ltd43c7f435-735c-3fab-e054-00144ff88e882024-11-13Warnings, Adverse reactionsExact identifier
application number: M013
DG Health Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDOLGENCORP, INC8f1343d5-2884-3a14-e053-2a95a90a2f902024-11-13WarningsExact identifier
application number: M013
Good Sense Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEGood Sensecd25b0c3-0134-beef-e053-2a95a90a092b2024-11-13WarningsExact identifier
application number: M013
Drug Mart Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDiscount Drug Mart, Inc8bc65603-1dbf-30ab-e053-2995a90a7c152024-11-13WarningsExact identifier
application number: M013
Best Choice Effervescent Antacid Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEValu Merchandisers Company8aab905b-5fe7-dddb-e053-2995a90a6c6f2024-11-13WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNd59c5f04-4bcc-4a52-a42f-e049506f00de3
198440acetaminophen 500 MG Oral TabletSCDd59c5f04-4bcc-4a52-a42f-e049506f00de3
198440APAP 500 MG Oral TabletSYd59c5f04-4bcc-4a52-a42f-e049506f00de3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-771-3658602077136250 TABLET in 1 BOTTLE (58602-771-36) 250 tablet2020-08-210000-00-00NoNoCurrent
58602-771-4058602077140500 TABLET in 1 BOTTLE (58602-771-40) 500 tablet2020-08-210000-00-00NoNoCurrent
58602-771-41586020771411000 TABLET in 1 BOTTLE (58602-771-41) 1000 tablet2020-08-210000-00-00NoNoCurrent
58602-771-6458602077164600 TABLET in 1 BOTTLE (58602-771-64) 600 tablet2021-05-170000-00-00NoNoCurrent