FDA.reportPublic FDA data

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 57 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
aspirinASPIRINA-S Medication Solutions65c41c20-2f9c-4012-900b-c2ffdf6651442024-11-06WarningsExact identifier
application number: M013
foster and thrive pain relieverACETAMINOPHENStrategic Sourcing Services LLC338021bd-b92b-45eb-a4b8-bc4a100ab7182024-11-06WarningsExact identifier
application number: M013
basic care headache reliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmazon.com Services LLCf85d2f4c-8184-4555-a310-3979722e860b2024-11-05WarningsExact identifier
application number: M013
MENSTRUAL COMPLETEMENSTRUAL COMPLETEAllegiant Healthd197b886-67e4-4aba-8582-305576c076042024-11-05WarningsExact identifier
application number: M013
dg health headache reliefACETAMINOPHEN, ASPIRIN, CAFFEINEDolgencorp Incddf40cc4-d73f-4460-be72-9486134329a72024-11-05WarningsExact identifier
application number: M013
DOLO- NeuroBion Acetaminophen 500mgACETAMINOPHENBENARD INDUSTRIES INC16f8415d-8190-4212-b487-c0caf7d3bee22024-11-04WarningsExact identifier
application number: M013
basic care acetaminophenACETAMINOPHENAmazon.com Services LLC8c3343ee-d7b6-496d-9702-6736539a72702024-11-02WarningsExact identifier
application number: M013
dg health pain reliefACETAMINOPHENDolgencorp, LLC382fa2cc-1c39-4bee-b528-08b11ec945af2024-11-02WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENBryant Ranch Prepackf7e20527-1d4b-434c-997b-3eb8211fdaa12024-11-01WarningsExact identifier
application number: M013
Aspirin Enteric Safety CoatedASPIRINPublix Supermarkets, Inc.a661a9ed-9b31-46b1-aafb-61d1ba8a49182024-11-01WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENBryant Ranch Prepack614e69c7-d3cb-4d47-9603-c1c14b87544c2024-11-01WarningsExact identifier
application number: M013
infants fever reducer and pain relieverACETAMINOPHENRite Aid Corporationbaee03b8-fcfd-440e-90ea-1ee2a18516ef2024-11-01WarningsExact identifier
application number: M013
good neighbor pharmacy infants pain and feverACETAMINOPHENAmerisource Bergenbfb954b7-3a79-4bca-95e8-d39e1074b07f2024-11-01WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELIEVERACETAMINOPHEN, ASPIRIN AND CAFFEINEProficient Rx LPbf365bfc-35cc-47f9-a50b-ff2b38d7316b2024-11-01WarningsExact identifier
application number: M013
Infants Pain ReliefACETAMINOPHENPublix Super Markets Inc0bc33897-afc2-4d11-be6c-a26480f448bf2024-10-31WarningsExact identifier
application number: M013
equate infants pain and feverACETAMINOPHENWALMART INC.34b2512e-743b-45db-92cb-ea05e2f47b3d2024-10-31WarningsExact identifier
application number: M013
foster and thrive infants pain and feverACETAMINOPHENStrategic Sourcing Services LLC45770ad6-9bf7-41bd-a724-e5260cd31fa12024-10-31WarningsExact identifier
application number: M013
Midol CompleteACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE TABLETLil' Drug Store Products, Inc.d20425a4-f074-4154-e053-2995a90ae9fd2024-10-30WarningsExact identifier
application number: M013
up and up infants acetaminophenACETAMINOPHENTarget Corporation31104956-04d7-41b5-82be-219ded5c02a92024-10-30WarningsExact identifier
application number: M013
Sunmark AspirinASPIRINStrategic Sourcing Services LLCa7139686-b351-47dc-a395-832429aaa5692024-10-30WarningsExact 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