Triclosan Free Antibacterial

Product NDC
57337-086
Requested package NDC
57337-086-01
11-digit product format
573370086
Labeler code
57337
Product ID
57337-086_2bdcf94b-0bed-9525-e063-6294a90ad80a
Type
HUMAN OTC DRUG
Nonproprietary name
Chloroxylenol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Rejoice International Corp.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2017-04-25
Substance
CHLOROXYLENOL
Active strength
.3 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57337-08657337-086-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
Triclosan Free Antibacterial
Brand name suffix
Antibacterial
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROXYLENOL.3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
413261Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e0038c8-5fb8-3a28-e054-00144ff8d46cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-086-01Triclosan Free AntibacterialAntibacterial443 mL in 1 BOTTLELIQUID4435

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-086TRICLOSAN FREE ANTIBACTERIAL ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [REJOICE INTERNATIONAL CORP.]5Current NDC, Legacy NDC, 1 package rows20250119_4e0038c8-5fb8-3a28-e054-00144ff8d46c.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
Triclosan Free Antibacterial AntibacterialCHLOROXYLENOLRejoice International Corp.4e0038c8-5fb8-3a28-e054-00144ff8d46c2025-01-16WarningsExact identifier
ndc (package): 57337-086-01
ndc (product): 57337-086
ndc11 (package): 57337008601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
413261chloroxylenol 0.3 % Medicated Liquid SoapPSN4e0038c8-5fb8-3a28-e054-00144ff8d46c5
413261chloroxylenol 3 MG/ML Medicated Liquid SoapSCD4e0038c8-5fb8-3a28-e054-00144ff8d46c5
413261chloroxylenol 0.3 % Medicated Liquid SoapSY4e0038c8-5fb8-3a28-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-086-0157337008601443 mL in 1 BOTTLE (57337-086-01) 443 ml2017-04-250000-00-00NoNoCurrent