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

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 Identifiers#

Field, Values table
FieldValues
UniiO414PZ4LPZ
Rxcui2714099

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

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