FDA.reportPublic FDA data

Cornex

Product NDC
82160-238
Requested package NDC
82160-238-01
11-digit product format
821600238
Labeler code
82160
Product ID
82160-238_e1de47ff-90a8-0b0d-e053-2a95a90a67c1
Type
HUMAN OTC DRUG
Nonproprietary name
Lactic Acid, Salicylic Acid
Dosage form
GEL
Route
TOPICAL
Labeler
Pella Pharmaceuticals Co. Ltd
Application
M030
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-03-25
Marketing end
0000-00-00
Substance
LACTIC ACID; SALICYLIC ACID
Active strength
2505 mg/15g; mg/15g
Pharmacologic classes
Acidifying Activity [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage82160-23882160-238-01IInactivated by FDA2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage82160-23882160-238-01UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage82160-23882160-238-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82160-238-01Cornex15 g in 1 TUBEGEL15242
82160-238-01Cornex1 in 1 CARTONGEL1242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82160-238CORNEX (LACTIC ACID, SALICYLIC ACID) GEL [PELLA PHARMACEUTICALS CO. LTD]242Legacy NDC, 2 package rows20250123_d0d10aa0-063e-0160-e053-2995a90a3b88.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 3 of 5 · 99 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Salicylic AcidMEDICATED CORN REMOVERSHarris Teeter, LLC0a8f8a45-bf6c-4a1e-9170-cf5b86581f162026-01-02WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CORN REMOVERHY-VEE, INC415f61b8-152e-7c4c-e063-6394a90a56792026-01-02WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CORN REMOVERSKroger Co.b5027cdf-d4d1-4e7b-bb02-967675a5c61c2026-01-02WarningsExact identifier
application number: M030
Salicylic AcidCORN REMOVERSPremier Brands of America Inc.f5b9f494-e4c9-40b9-93a5-4b8c03cc598b2026-01-02WarningsExact identifier
application number: M030
Corn RemoversSALICYLIC ACIDWinCo Foods LLC15d7cce9-cf52-f417-e063-6394a90af9fc2026-01-02WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CORN REMOVERSHudson Health LLC6168e9a0-48df-4033-a6fc-17ec2895574f2026-01-02WarningsExact identifier
application number: M030
Medicated Callus Removers Extra ThickSALICYLIC ACIDMeijer Distribution Inc039bcd7d-9a71-a1aa-e063-6294a90a09532026-01-02WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CORN REMOVERSUnited Natural Foods, Inc. dba UNFIbdb567a7-77d0-49d7-be63-0c6a4aaa21cf2026-01-02WarningsExact identifier
application number: M030
Salicylic acidMEDICATED CALLUS REMOVERS EXTRA THICKUnited Natural Foods, Inc. dba UNFI0f791171-d102-405f-b3ef-514ca7fdd2d52025-12-31WarningsExact identifier
application number: M030
Medicated Callus RemoversSALICYLIC ACIDMeijer Distribution Inc.0399ebde-c7d1-f73d-e063-6294a90a020f2025-12-30WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CALLUS REMOVERSChain Drug Marketing Association339d658b-9949-8493-e063-6294a90a0bbe2025-12-30WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CORN REMOVERSHudson Health LLCa3eb0589-738d-4954-85c9-472c7124a0162025-12-30WarningsExact identifier
application number: M030
Medicated Corn RemoverSALICYLIC ACIDDolgencorp, Inc. (Dollar General & Rexall)ec6d0cc7-edf2-df6e-e053-2a95a90a57862025-12-30WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CORN REMOVERPremier Brands of America Inc.38ccd276-d7b3-9604-e063-6394a90ac04b2025-12-30WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CORN REMOVERSFoodhold USA3c9ce19d-e16d-47a8-90ff-46b23e51011b2025-12-30WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CORN REMOVERFSA Store Inc.3cd17f19-6e54-a618-e063-6394a90abba42025-12-30WarningsExact identifier
application number: M030
Medicated Corn RemoversSALICYLIC ACIDFamily Dollar Services, Inc177ebc9a-6a63-31f8-e063-6394a90a8b2a2025-12-30WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CALLUS REMOVERSFoodhold USA29e3caa0-4dc5-44d7-b7db-8bf45f6424ea2025-12-29WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CALLUS REMOVERSAmerisourceBergen Drug Corporation6aa867ee-4dd0-4308-9841-898d1ffe1edd2025-12-29WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CALLUS REMOVERSHarris Teeter, LLC0e649195-2e3b-48da-99e6-6f2c7fd686f22025-12-29WarningsExact identifier
application number: M030

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
244534lactic acid 16.7 % / salicylic acid 16.7 % Topical GelPSNd0d10aa0-063e-0160-e053-2995a90a3b88242
244534lactic acid 0.167 MG/MG / salicylic acid 0.167 MG/MG Topical GelSCDd0d10aa0-063e-0160-e053-2995a90a3b88242
244534lactic acid 16.7 % / salicylic acid 16.7 % Topical GelSYd0d10aa0-063e-0160-e053-2995a90a3b88242
244534lactic acid 167 MG / salicylic acid 167 MG per 1 GM Topical GelSYd0d10aa0-063e-0160-e053-2995a90a3b88242

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82160-238-01821600238011 TUBE in 1 CARTON (82160-238-01) > 15 g in 1 TUBE1 tube2010-03-250000-00-00NoNoCurrent