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 5 of 5 · 99 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Salicylic AcidCORN AND CALLUS REMOVER KITVALU MERCHANDISERS, COd37b1c38-2805-40e1-875b-85bb40914c802025-08-26WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CALLUS REMOVERSChain Drug Marketing Association38bc5256-35b1-444d-bba0-6d4dd56f544e2025-08-14WarningsExact identifier
application number: M030
Wart RemoverSALICYLIC ACIDWorld Perfumes Inc3a14cba2-c24d-5a28-e063-6394a90a5b702025-07-16WarningsExact identifier
application number: M030
Lunavia Salicylic Acid Foot CreamSALICYLIC ACID 12%XF Agencija Limited3c44de4b-caca-4aa7-951c-17edd4dd66682025-06-16WarningsExact identifier
application number: M030
Salicylic AcidSALICYLIC ACID 12%SANSAR, LLCec6f14a4-ba91-4202-b8b9-2edf2cebe7482025-06-16WarningsExact identifier
application number: M030
Compound W Corn RemoverSALICYLIC ACIDMedtech Products Inc.a13037aa-13f3-4ffd-a5ae-f0962013b0f72025-05-13WarningsExact identifier
application number: M030
Lavender Callus RemoverSALICYLIC ACID 12%SANSAR, LLC4763bab3-631a-4fcf-8387-d7df4e89e0e42025-05-09WarningsExact identifier
application number: M030
Tea Tree Oil Callus RemoverSALICYLIC ACID 12%SANSAR, LLC4acfedbf-d1af-47a9-8258-1214343830c62025-05-09WarningsExact identifier
application number: M030
ndc (product): 83691-007
Foot ScrubSALICYLIC ACID 12%SANSAR, LLCc7c93b68-e1e8-46c4-91db-095159572f412025-05-07WarningsExact identifier
application number: M030
Walgreens Corn RemoverSALICYLIC ACIDWALGREENS Co1ebfabc0-22be-468e-8a69-86b565f2773e2025-05-02WarningsExact identifier
application number: M030
MQUPIN Corn Removal PadsCORN REMOVAL PADSZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd09769ae3-d19d-e2dd-e063-6294a90a1f642025-03-24WarningsExact identifier
application number: M030
MYMULIKE Corn Removal PadsCORN REMOVAL PADSZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd09777a9d-2dd1-4f87-e063-6294a90ac1392025-03-24WarningsExact identifier
application number: M030
Biopure Medicated Wart Remover StripsSALICYLIC ACID, WART REMOVERQUEST USA CORP2f27a258-a2b8-ca2c-e063-6294a90a073c2025-03-07WarningsExact identifier
application number: M030
Wart RemoverSALICYLIC ACIDPharmaplast SAEa581fcf8-b406-48af-b358-87531e3486a22025-01-07WarningsExact identifier
application number: M030
Cure-Aid Corn PlastersSALICYLIC ACIDPharmaplast SAE31a48f6a-37f5-4779-8040-0b13268b73502025-01-07WarningsExact identifier
application number: M030
Salicylic AcidMEDICATED CORN REMOVERSUnited Natural Foods, Inc.fc74e8cb-a7b1-56b3-e053-6394a90a44ae2024-12-12WarningsExact identifier
application number: M030
CornStickSALICYLIC ACIDBalassa Laboratories Inc.c453b06e-f9b0-4099-949a-6f5d2a8577e82024-10-01WarningsExact identifier
application number: M030
Samsali Wart Corn Remover PadsWART CORN REMOVER PADSShenzhen Xinxin Yunhai Technology Co., Ltd.186314fe-9438-b1f5-e063-6294a90a99032024-09-19WarningsExact identifier
application number: M030
Satos Corn and Callus RemoverSALICYLIC ACIDSato Pharmaceutical Co., Ltd.eff7234c-4ae0-4ac2-8ab4-9312fd4dd2a32023-12-04WarningsExact 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