SaniTex 60

Product NDC
82488-693
Requested package NDC
82488-693-03
11-digit product format
824880693
Labeler code
82488
Product ID
82488-693_28c5381b-347f-b812-e063-6394a90afc33
Type
HUMAN OTC DRUG
Nonproprietary name
SaniTex 60
Dosage form
LIQUID
Route
TOPICAL
Labeler
Solutex, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-08
Substance
ALCOHOL
Active strength
67 mL/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
SaniTex 60
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL67 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d57827ec-f724-5081-e053-2a95a90adaafAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82488-693-02SaniTex 60236 mL in 1 BOTTLE, PLASTICLIQUID2362
82488-693-03SaniTex 603785 mL in 1 BOTTLE, PLASTICLIQUID37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82488-693SANITEX 60 LIQUID [SOLUTEX, INC.]2Current NDC, Legacy NDC, 2 package rows20241209_d57827ec-f724-5081-e053-2a95a90adaaf.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SaniTex 60SANITEX 60Solutex, Inc.d57827ec-f724-5081-e053-2a95a90adaaf2024-12-08WarningsExact identifier
ndc (package): 82488-693-03
ndc (product): 82488-693
ndc11 (package): 82488069303

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82488-693-03824880693033785 mL in 1 BOTTLE, PLASTIC (82488-693-03) 3785 ml2020-04-080000-00-00NoNoCurrent