FDA.reportPublic FDA data

Fresh Start

Product NDC
63830-950
11-digit product format
638300950
Labeler code
63830
Product ID
63830-950_518cee25-e259-0a55-e063-6394a90a4ea0
Type
HUMAN OTC DRUG
Nonproprietary name
CHLOROXYLENOL
Dosage form
SOAP
Route
TOPICAL
Labeler
Pro Chem, Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-20
Substance
CHLOROXYLENOL
Active strength
3 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 2 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 productproduct63830-950UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63830-95063830-950-06UExcluded 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
Fresh Start
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROXYLENOL3 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 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
dd1708d8-0bb2-c96a-e053-2995a90a5b86Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63830-950-06Fresh Start1 in 1 BOXSOAP13
63830-950-06Fresh Start800 mL in 1 BAGSOAP8003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63830-950FRESH START (CHLOROXYLENOL) SOAP [PRO CHEM, INC.]2Current NDC, Legacy NDC, 2 package rows20250114_dd1708d8-0bb2-c96a-e053-2995a90a5b86.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 19 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple Antibiotic First Aid AntibioticBACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATEUniversal Distribution Center LLC78f00296-267b-44c3-a9e3-c40f122e905e2024-05-14WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEJHK Inc dba American Safety & First Aid26e66025-9457-42b3-9319-51302c17506e2024-04-26WarningsExact identifier
application number: M004
Hydrogen PeroxideHYDROGEN PEROXIDEJHK Inc1472c854-09c8-4ad8-b8a6-0235440ac26b2024-04-26WarningsExact identifier
application number: M004
Isopropyl AlcoholISOPROPYL ALCOHOLJHK Incabae6a80-e859-47b5-8e34-d391eb8545832024-04-26WarningsExact identifier
application number: M004
AntisepticBENZALKONIUM CHLORIDE, BENZOCAINEJHK Inc0ac5d890-c262-4a30-9fd8-2de6cb0f76012024-04-25WarningsExact identifier
application number: M004
First Aid Antibiotic Bacitracin Zinc Neomycin Sulfate Polymyxin B SulfateBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEM-star (Hubei) Health&Care Products Co., Ltd.c6f2656e-b822-4d61-b557-dd2046dd51f52024-04-01WarningsExact identifier
application number: M004
AntibioticBACITRACIN ZINC, POLYMYXIN B SULFATECVS PHARMACY, INC32e92acf-2e48-4933-8e08-e1df650e7d192024-03-15WarningsExact identifier
application number: M004
Major BacitracinBACITRACINMajor Pharmaceuticals13288efb-e282-68f8-e063-6294a90ae7122024-03-08WarningsExact identifier
application number: M004
UniShield TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnishield00b85d3a-322b-43c1-b022-5f6ed50c66092024-03-02WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEChain Drug Marketing Association Inc.1277942d-753f-ab69-e063-6394a90a496a2024-02-28WarningsExact identifier
application number: M004
Triple Antibiotic with Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDESafetec of America, Inc.ca1df4a0-844d-4b1d-b972-f2704a8ebbab2024-02-16WarningsExact identifier
application number: M004
Single AntibioticBACITRACIN ZINCSafetec of America, Inc.9993c204-6e61-4da3-90ef-2b7dfa09c9202024-02-14WarningsExact identifier
application number: M004
Single Antibiotic with NeomycinNEOMYCIN SULFATESafetec of Americae989cf7e-f3d1-42d2-af45-fc80095b97cb2024-02-08WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.96c41fc1-81f9-4757-abc6-867b5383ed5d2024-02-07WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.2c2aa8af-2adb-4f59-ac20-15818d0e28e72024-02-07WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.03c05028-5a5f-4690-a836-cc1b1044ab392024-02-05WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.59494d5c-dd8a-431c-8e6a-4e1151ba74602024-02-05WarningsExact identifier
application number: M004
Triple AntibioticFIRST AID ANTIBIOTICBluePoint Laboratoriesc47e15bd-1062-4cca-e053-2995a90a90752024-01-31WarningsExact identifier
application number: M004
NeomycinNEOMYCIN OINTMENTDynarex Corporation0f9e087b-6e86-a3c7-e063-6394a90ac8d42024-01-23WarningsExact identifier
application number: M004
Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETarget Corporation050be94c-1fbb-4d84-82c6-841aac8f318e2024-01-18WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
413261chloroxylenol 0.3 % Medicated Liquid SoapPSNdd1708d8-0bb2-c96a-e053-2995a90a5b863
413261chloroxylenol 3 MG/ML Medicated Liquid SoapSCDdd1708d8-0bb2-c96a-e053-2995a90a5b863
413261chloroxylenol 0.3 % Medicated Liquid SoapSYdd1708d8-0bb2-c96a-e053-2995a90a5b863

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63830-950-06638300950061 BAG in 1 BOX (63830-950-06) / 800 mL in 1 BAG1 bag2022-04-200000-00-00NoNoCurrent