FDA.reportPublic FDA data

Tea Tree Oil Callus Remover

Product NDC
83691-007
11-digit product format
836910007
Labeler code
83691
Product ID
83691-007_8e813ae3-55b7-4eb8-abd8-505bd1e7ed83
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid 12%
Dosage form
GEL
Route
TOPICAL
Labeler
SANSAR, LLC
Application
M030
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-09
Substance
SALICYLIC ACID
Active strength
12 g/100mL
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
Tea Tree Oil Callus Remover
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID12 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2714099Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4acfedbf-d1af-47a9-8258-1214343830c6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83691-007-01Tea Tree Oil Callus Remover236 mL in 1 BOTTLEGEL2361
83691-007-01Tea Tree Oil Callus Remover1 in 1 CARTONGEL11
83691-007-02Tea Tree Oil Callus Remover236 mL in 1 BOTTLEGEL2361
83691-007-02Tea Tree Oil Callus Remover2 in 1 CARTONGEL21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83691-007TEA TREE OIL CALLUS REMOVER (SALICYLIC ACID 12%) GEL [SANSAR, LLC]1Current NDC, 4 package rows20250514_4acfedbf-d1af-47a9-8258-1214343830c6.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
2714099salicylic acid 12 % Topical GelPSN4acfedbf-d1af-47a9-8258-1214343830c61
2714099salicylic acid 0.12 MG/MG Topical GelSCD4acfedbf-d1af-47a9-8258-1214343830c61
2714099salicylic acid 12 % Topical GelSY4acfedbf-d1af-47a9-8258-1214343830c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83691-007-01836910007011 BOTTLE in 1 CARTON (83691-007-01) / 236 mL in 1 BOTTLE1 bottle2025-05-09NoNoCurrent
83691-007-02836910007022 BOTTLE in 1 CARTON (83691-007-02) / 236 mL in 1 BOTTLE2 bottle2025-05-09NoNoCurrent