Saniwash Antimicrobial

Product NDC
61010-1122
11-digit product format
610101122
Labeler code
61010
Product ID
61010-1122_10a74b7b-a6c3-f224-e063-6294a90a4f67
Type
HUMAN OTC DRUG
Nonproprietary name
Chloroxylenol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Safetec of America, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-04-22
Substance
CHLOROXYLENOL
Active strength
.006 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61010-112261010-1122-4DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
Saniwash Antimicrobial
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROXYLENOL.006 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0F32U78V2QInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6ac9df02-225d-4115-a9c6-a492faafe68aAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-1122-3Saniwash Antimicrobial473 mL in 1 BOTTLE, PUMPLIQUID4734
61010-1122-4Saniwash Antimicrobial800 mL in 1 BAGLIQUID8004
61010-1122-6Saniwash Antimicrobial3785 mL in 1 BOTTLE, PUMPLIQUID37854
61010-1122-7Saniwash Antimicrobial208198 mL in 1 DRUMLIQUID2081984

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ChloroxylenolACTIVE INGREDIENT0F32U78V2QSANIWASH ANTIMICROBIAL (CHLOROXYLENOL) LIQUID [SAFETEC OF AMERICA, INC.]2
ChloroxylenolACTIVE MOIETY0F32U78V2QSANIWASH ANTIMICROBIAL (CHLOROXYLENOL) LIQUID [SAFETEC OF AMERICA, INC.]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SANIWASH ANTIMICROBIAL (CHLOROXYLENOL) LIQUID [SAFETEC OF AMERICA, INC.]2
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0XSANIWASH ANTIMICROBIAL (CHLOROXYLENOL) LIQUID [SAFETEC OF AMERICA, INC.]2
Cocamidopropyl BetaineINACTIVE INGREDIENT5OCF3O11KXSANIWASH ANTIMICROBIAL (CHLOROXYLENOL) LIQUID [SAFETEC OF AMERICA, INC.]2
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972DSANIWASH ANTIMICROBIAL (CHLOROXYLENOL) LIQUID [SAFETEC OF AMERICA, INC.]2
Diazolidinyl UreaINACTIVE INGREDIENTH5RIZ3MPW4SANIWASH ANTIMICROBIAL (CHLOROXYLENOL) LIQUID [SAFETEC OF AMERICA, INC.]2
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUSANIWASH ANTIMICROBIAL (CHLOROXYLENOL) LIQUID [SAFETEC OF AMERICA, INC.]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TSANIWASH ANTIMICROBIAL (CHLOROXYLENOL) LIQUID [SAFETEC OF AMERICA, INC.]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3SANIWASH ANTIMICROBIAL (CHLOROXYLENOL) LIQUID [SAFETEC OF AMERICA, INC.]2
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHSANIWASH ANTIMICROBIAL (CHLOROXYLENOL) LIQUID [SAFETEC OF AMERICA, INC.]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XSANIWASH ANTIMICROBIAL (CHLOROXYLENOL) LIQUID [SAFETEC OF AMERICA, INC.]2
SODIUM LAURETH-3 SULFATEINACTIVE INGREDIENTBPV390UAP0SANIWASH ANTIMICROBIAL (CHLOROXYLENOL) LIQUID [SAFETEC OF AMERICA, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RSANIWASH ANTIMICROBIAL (CHLOROXYLENOL) LIQUID [SAFETEC OF AMERICA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-1122SANIWASH ANTIMICROBIAL (CHLOROXYLENOL) LIQUID [SAFETEC OF AMERICA, INC.]4Current NDC, Legacy NDC, 4 package rows20240214_6ac9df02-225d-4115-a9c6-a492faafe68a.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
Saniwash AntimicrobialCHLOROXYLENOLSafetec of America, Inc.6ac9df02-225d-4115-a9c6-a492faafe68a2024-02-05WarningsExact identifier
ndc (product): 61010-1122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61010-1122-361010112203473 mL in 1 BOTTLE, PUMP (61010-1122-3) 473 ml2014-04-220000-00-00NoNoCurrent
61010-1122-461010112204800 mL in 1 BAG800 mlHistorical
61010-1122-6610101122063785 mL in 1 BOTTLE, PUMP (61010-1122-6) 3785 ml2014-04-220000-00-00NoNoCurrent
61010-1122-761010112207208198 mL in 1 DRUM (61010-1122-7) 208198 ml2014-04-220000-00-00NoNoCurrent