FDA.reportPublic FDA data

El Mata Callos

Product NDC
69469-017
11-digit product format
694690017
Labeler code
69469
Product ID
69469-017_38429f3a-9adb-1e4f-e063-6294a90ac1a4
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Vitamex USA, Corp
Application
M028
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-05
Substance
SALICYLIC ACID
Active strength
170 mg/mL
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
El Mata Callos
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID170 mg/mL

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
312881Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
21c6206e-9183-3e4f-e063-6394a90a33f7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69469-017-05El Mata Callos15 mL in 1 BOTTLE, WITH APPLICATORSOLUTION152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69469-017EL MATA CALLOS (SALICYLIC ACID) SOLUTION [VITAMIN USA, CORP]1Current NDC, 1 package rows20240912_21c6206e-9183-3e4f-e063-6394a90a33f7.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 16 of 16 · 305 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ulensy Corn Callus and Wart RemoverCORN CALLUS AND WART REMOVERShenzhen Xinxin Yunhai Technology Co., Ltd.0f3353ef-e105-7bd4-e063-6394a90a25622024-01-18WarningsExact identifier
application number: M028
WARTRIN Wart RemoverSALICYLIC ACIDBALBOA COMPANIES LLC62c99f48-3dc1-4b41-8bc4-e93e2decadd92023-11-11WarningsExact identifier
application number: M028
UFORIC Wart RemoverSALICYLIC ACIDUFORIC HEALTH LLC0d06cac6-5296-4d8a-b59e-966baac6be5f2023-11-06WarningsExact identifier
application number: M028
WARTOVIR Wart RemoverSALICYLIC ACIDBALBOA COMPANIES LLC2dbf5b40-d759-4c37-8dfe-3b65a7e6dbb62023-11-06WarningsExact identifier
application number: M028
VerruStat Wart RemoverSALICYLIC ACIDClinical Therapeutic Solutions16607d6e-6a5f-4b03-b38c-3610aef9b1652023-11-05WarningsExact identifier
application number: M028

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312881salicylic acid 17 % Topical SolutionPSN21c6206e-9183-3e4f-e063-6394a90a33f72
312881salicylic acid 170 MG/ML Topical SolutionSCD21c6206e-9183-3e4f-e063-6394a90a33f72
312881salicylic acid 17 % Topical SolutionSY21c6206e-9183-3e4f-e063-6394a90a33f72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69469-017-056946900170515 mL in 1 BOTTLE, WITH APPLICATOR (69469-017-05) 15 ml2024-09-09NoNoCurrent