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 2 of 5 · 99 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Salicylic AcidCORN AND CALLUS REMOVER KITWal-Mart Stores, Inc.259fcbbd-08a2-cfcb-e063-6394a90ae7d12026-02-05WarningsExact identifier
application number: M030
Extra Thick Callus RemoversEXTRA THICK CALLUS REMOVERS WITH SALICYLIC ACIDWal-Mart Stores, Inc.83f3b428-e914-419b-8fa3-5444647a70612026-01-30WarningsExact identifier
application number: M030
Mqupin Liquid Wart Corn RemoverLIQUID WART CORN REMOVERZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd09789de2-4e81-a6ed-e063-6394a90af5e02026-01-28WarningsExact identifier
application number: M030
Salicylic acidMEDICATED CORN REMOVERSWal-Mart Stores Inc80c4907d-d4ea-42b0-e053-2a91aa0a173c2026-01-21WarningsExact identifier
application number: M030
Salicylic AcidCORN REMOVERSWalgreen Company249ba77f-fba4-41b4-83df-3f46fb94835a2026-01-20WarningsExact identifier
application number: M030
Salicylic AcidEXTRA THICK CALLUS REMOVERSWalgreen Companyfa2e95b5-fe90-4406-b981-05bca62fd25c2026-01-20WarningsExact identifier
application number: M030
Salicylic AcidCLEAR MEDICATED CORN REMOVERSWalgreens Companyf691fbf6-5e74-bac8-e053-2a95a90a67142026-01-20WarningsExact identifier
application number: M030
Salicylic AcidULTRA THIN CORN REMOVERSWalgreens Company822c6cbe-15a7-4183-b28b-f00a1d2c85242026-01-20WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CALLUS REMOVERSVALU MERCHANDISERS, CO468fd593-8b40-41b2-b419-d6550ed625412026-01-15WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CORN REMOVERSVALU MERCHANDISERS, COee15daa4-3325-4b16-8f84-ac7d39fa0aec2026-01-15WarningsExact identifier
application number: M030
Salicylic acidMEDICATED CALLUS REMOVERS EXTRA THICKVALU MERCHANDISERS, COdd3c2727-e250-4a35-9256-856a775b948b2026-01-15WarningsExact identifier
application number: M030
Salicylic acidMEDICATED CALLUS REMOVERS EXTRA THICKHEB51acb7ae-0217-4f35-853b-bdbea858482d2026-01-15WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CORN REMOVERSHEB553ff475-641d-4cc0-ab32-69cebec709ba2026-01-15WarningsExact identifier
application number: M030
Clear Corn Remover StripsSALICYLIC ACIDMEIJER DISTRIBUTION, INC.f83601c0-86b8-90fa-e053-6294a90af8322026-01-15WarningsExact identifier
application number: M030
Medicated Corn RemoversSALICYLIC ACIDMeijer Distribution Inc039da93c-5351-36f3-e063-6294a90aacb42026-01-15WarningsExact identifier
application number: M030
Salicylic AcidCLEAR MEDICATED CORN REMOVERSPremier Brands of America Inc.f5626988-a23d-44ea-e053-2a95a90a6bd02026-01-15WarningsExact identifier
application number: M030
Salicylic acidMEDICATED CALLUS REMOVERS EXTRA THICKTopco Associates LLC397cbf46-a4d5-4fc4-a04e-ef947b638b472026-01-15WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CORN REMOVERSTopco Associates LLC7e94a826-4f6d-451a-b599-70f337aa287c2026-01-15WarningsExact identifier
application number: M030
Salicylic AcidCLEAR MEDICATED CORN REMOVERSCVS Pharmacyf55fd921-8b79-48e5-e053-2995a90acc782026-01-08WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CORN REMOVERSAmerisourceBergen Drug Corporationf407f14a-7c5c-481d-b1d1-1ea94b3a30292026-01-02WarningsExact 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