FDA.reportPublic FDA data

PEARL ANTIMICROBIAL HAND

Product NDC
50536-127
11-digit product format
505360127
Labeler code
50536
Product ID
50536-127_337bfded-2246-9549-e063-6394a90a9622
Type
HUMAN OTC DRUG
Nonproprietary name
CHLOROXYLENOL
Dosage form
SOAP
Route
TOPICAL
Labeler
AMERICAN CHEMICAL AND SANITARY SUPPLY INC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-03-12
Substance
CHLOROXYLENOL
Active strength
.3 g/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
PEARL ANTIMICROBIAL HAND
Brand name suffix
ITEM 1027AB-01
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
1871b1db-f881-e7fd-e063-6294a90ada98Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50536-127-01PEARL ANTIMICROBIAL HANDITEM 1027AB-013785 mL in 1 JUGSOAP37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50536-127PEARL ANTIMICROBIAL HAND ITEM 1027AB-01 (CHLOROXYLENOL) SOAP [AMERICAN CHEMICAL AND SANITARY SUPPLY INC]2Current NDC, 1 package rows20250425_1871b1db-f881-e7fd-e063-6294a90ada98.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 43 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d40204-3f69-7fb7-e053-2995a90a278b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTIBACTERIAL HAND WIPEUnico International Trading Corpad7d8546-d440-e661-e053-2a95a90a8fd32026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d47c07-12bd-3c8f-e053-2a95a90a95642026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d7f260-f5be-7940-e053-2995a90aaa032026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTIBACTERIALUnico International Trading Corpada02f20-07ef-9e90-e053-2995a90a0e8b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-BACTERIALUnico International Trading Corpadb59182-6541-2b35-e053-2a95a90a0f712026-01-08WarningsExact identifier
application number: M003
Castellani Paint 1.5%PHENOLThe Podiatree Companya10f18e0-b47c-424b-847e-bcc25aa250a42026-01-08WarningsExact identifier
application number: M003
Castellani Paint 1.5%PHENOLThe Podiatree Company5b8cff3c-71d2-418f-a43d-f570aa5408fd2026-01-08WarningsExact identifier
application number: M003
Fortinia IDPHENOLThe Podiatree Company60c88eb7-22fe-4881-e053-2a91aa0a70ce2026-01-08WarningsExact identifier
application number: M003
Gentian Violet 2%GENTIAN VIOLET 2%The Podiatree Company60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b82026-01-08WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLNDC, Inc.07bfadf4-7452-4c7a-b60e-feb658b92e732026-01-08WarningsExact identifier
application number: M003
Hydrogen Peroxide 3%HYDROGEN PEROXIDE 3%Epic Medical Supply Corp.0da45476-46c3-428c-a2d9-70865d2b12772026-01-08WarningsExact identifier
application number: M003
Roll On Anti Perspirant Alcohol FreeALUMINUM CHLOROHYDRATEMedline Industries, LP4f706801-dc2d-48c4-aa06-92207d86e55e2026-01-08WarningsExact identifier
application number: M003
ProCure Antiseptic Wound CleanserBENZETHONIUM CHLORIDE 0.13%Twin Med LLC47e63ead-fdcc-15e9-e063-6394a90af8fa2026-01-08WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMcKesson Medical-Surgical Inc.57ac1673-0652-433b-8b79-962d14e5b3172026-01-08WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLHenry Schein Inc.eeaf255e-497b-4672-bebc-4d3fcba904c72026-01-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEMcKesson Medical-Surgical Inc.fefaf5ff-e5f4-40d9-a415-a54fb5592ae12026-01-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDENavajo Manufacturing Company Inc.0125929d-fabe-4e35-a3a9-a81c42211bed2026-01-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEMcKesson Medical-Surgical Inc.85d2d57d-6d0b-406a-8880-a697a8c3c6822026-01-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEHenry Schein Inc.d97671f0-b182-4dab-87d2-cf9919509da52026-01-08WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
413261chloroxylenol 0.3 % Medicated Liquid SoapPSN1871b1db-f881-e7fd-e063-6294a90ada982
413261chloroxylenol 3 MG/ML Medicated Liquid SoapSCD1871b1db-f881-e7fd-e063-6294a90ada982
413261chloroxylenol 0.3 % Medicated Liquid SoapSY1871b1db-f881-e7fd-e063-6294a90ada982

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50536-127-01505360127013785 mL in 1 JUG (50536-127-01) 3785 ml2014-03-12NoNoCurrent