Triclosan Free Antibacterial 7.5 oz (Ocean)

Product NDC
57337-088
Requested package NDC
57337-088-01
11-digit product format
573370088
Labeler code
57337
Product ID
57337-088_2d763fe8-b777-3120-e063-6294a90a217e
Type
HUMAN OTC DRUG
Nonproprietary name
Chloroxylenol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Rejoice International Corp.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2017-06-06
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 · 3 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
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57337-08857337-088-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57337-08857337-088-01UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57337-08857337-088-01UExcluded 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 7.5 oz (Ocean)
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
5160c9e0-cae5-66e2-e054-00144ff88e88Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-088-012025-02-06C16284748780-12cef2736-998e-d83d-e063-dadaa90ab31fTriclosan Free Antibacterial 7.5 oz (Ocean)
57337-088-012025-01-30C16284748780-12cef2736-998e-d83d-e063-dadaa90ab31fTriclosan Free Antibacterial 7.5 oz (Ocean)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-088-01Triclosan Free Antibacterial 7.5 oz (Ocean)Antibacterial221 mL in 1 BOTTLELIQUID2213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-088TRICLOSAN FREE ANTIBACTERIAL 7.5 OZ (OCEAN) ANTIBACTERIAL (CHLOROXYLENOL) LIQUID [REJOICE INTERNATIONAL CORP.]3Current NDC, Legacy NDC, 1 package rows20250209_5160c9e0-cae5-66e2-e054-00144ff88e88.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 7.5 oz (Ocean) AntibacterialCHLOROXYLENOLRejoice International Corp.5160c9e0-cae5-66e2-e054-00144ff88e882025-02-06WarningsExact identifier
ndc (package): 57337-088-01
ndc (product): 57337-088
ndc11 (package): 57337008801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
413261chloroxylenol 0.3 % Medicated Liquid SoapPSN5160c9e0-cae5-66e2-e054-00144ff88e883
413261chloroxylenol 3 MG/ML Medicated Liquid SoapSCD5160c9e0-cae5-66e2-e054-00144ff88e883
413261chloroxylenol 0.3 % Medicated Liquid SoapSY5160c9e0-cae5-66e2-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-088-0157337008801221 mL in 1 BOTTLE (57337-088-01) 221 ml2017-06-060000-00-00NoNoCurrent