Aurophen Regular Strength

Product NDC
58602-754
11-digit product format
586020754
Labeler code
58602
Product ID
58602-754_0b463c9c-6ad9-20df-e063-6394a90a427a
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
325 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 Regular Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 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
313782Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8eda893f-5266-4b7a-95b9-2e194973cf06Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-754-07Aurophen Regular Strength24 in 1 BOTTLETABLET244
58602-754-07Aurophen Regular Strength1 in 1 CARTONTABLET14
58602-754-14Aurophen Regular Strength50 in 1 BOTTLETABLET504
58602-754-14Aurophen Regular Strength1 in 1 CARTONTABLET14
58602-754-21Aurophen Regular Strength100 in 1 BOTTLETABLET1004
58602-754-21Aurophen Regular Strength1 in 1 CARTONTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-754AUROPHEN REGULAR STRENGTH (ACETAMINOPHEN) TABLET [AUROHEALTH LLC]4Current NDC, Legacy NDC, 6 package rows20231130_8eda893f-5266-4b7a-95b9-2e194973cf06.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 2 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAX relief junior GrapeCHILDRENS ACETAMINOPHENAkron Pharma Inc.cc769c26-556a-4831-bd75-61a7383aa7072026-08-31WarningsExact identifier
application number: M013
MAX relief juniorCHILDRENS ACETAMINOPHENAkron Pharma Inc.ebb3b4ba-2d0b-48d9-b6ee-6d4696aea0472026-08-31WarningsExact identifier
application number: M013
MAX relief juniorACETAMINOPHENAkron Pharma Inc.0e43b885-3843-4f11-9a53-02a38c2283132026-08-31WarningsExact identifier
application number: M013
MAX relief juniorCHILDREN ACETAMINOPHENAkron Pharma Inc.d7874e4d-0b38-4bb1-9a62-aa4f66d9baf92026-08-31WarningsExact identifier
application number: M013
MAX relief junior GrapeCHILDREN ACETAMINOPHENAkron Pharma Inc.3c7a7f40-4963-4fd1-942e-93fa08a458302026-08-31WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.5a615118-33c9-1520-e063-6394a90a21a62026-08-31WarningsExact identifier
application number: M013
acetaminophen pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLSam's West Inccff9a730-2241-4e4c-bf6b-a2fa895e24172026-08-31WarningsExact identifier
application number: M013
acetaminophen extra strengthACETAMINOPHENSam's West Incdd99efd0-4ca4-4dc6-a940-bebd17ac8f8d2026-08-28WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINHAWAII REPACK, INC.ac94cce3-9a39-41de-bb8b-10a5e5b8e83b2026-08-28WarningsExact identifier
application number: M013
AspirinASPIRINWinCo Foods, LLCa0a19cd1-eb8a-4773-be00-78de90d2a3c32026-08-28WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENFSA STORE INC.5502ef15-9f40-db56-e063-6394a90a2de42026-08-26WarningsExact identifier
application number: M013
Dye Free Pain and Fever ChildrensACETAMINOPHENWalgreens3ea217dd-e5b9-4d4b-861a-76ce61ba3a1d2026-08-26WarningsExact identifier
application number: M013
HyVee Extra Strength Headache Relief CAPLETACETAMINOPHEN, ASPIRIN, CAFFEINEHyVee Inc495c75bf-c09a-accd-e063-6294a90a75ec2026-08-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWalgreens543f93d1-df14-0bd2-e063-6294a90a44132026-08-24WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.ab79fd60-8315-4c63-8045-1b0511ac268f2026-08-24WarningsExact identifier
application number: M013
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.4fd048c3-70bc-2ea7-e063-6394a90a55f22026-08-22WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.59adabeb-97e8-2de4-e063-6394a90acc472026-08-22WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPublix Super Markets Inca876daa7-ade3-497d-87bb-46d6e4dc185a2026-08-21WarningsExact identifier
application number: M013
equate aspirinASPIRINWal-Mart Stores Incea3f8eed-7b70-4156-9586-125d27bf29a82026-08-19WarningsExact identifier
application number: M013
CARDIASPIRIN PROTECTASPIRINOPMX LLC03774690-662b-1c30-e063-6294a90a34882026-08-19WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSN8eda893f-5266-4b7a-95b9-2e194973cf064
313782acetaminophen 325 MG Oral TabletSCD8eda893f-5266-4b7a-95b9-2e194973cf064
313782APAP 325 MG Oral TabletSY8eda893f-5266-4b7a-95b9-2e194973cf064

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-754-07586020754071 BOTTLE in 1 CARTON (58602-754-07) / 24 TABLET in 1 BOTTLE1 bottle2016-02-260000-00-00NoNoCurrent
58602-754-14586020754141 BOTTLE in 1 CARTON (58602-754-14) / 50 TABLET in 1 BOTTLE1 bottle2016-02-260000-00-00NoNoCurrent
58602-754-21586020754211 BOTTLE in 1 CARTON (58602-754-21) / 100 TABLET in 1 BOTTLE1 bottle2016-02-260000-00-00NoNoCurrent