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 53 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ORANGE HAND SANITIZER aloe and vitamin EALCOHOLGanzhou Olivee Cosmetic Co., Ltd.a9c1e4f6-e354-4624-a902-8c9154ea47232025-11-25WarningsExact identifier
application number: M003
COCONUT HAND SANITIZER aloe and vitamin EALCOHOLGanzhou Olivee Cosmetic Co., Ltd.40d7fb84-4b39-440d-a590-8aaf8ec312d72025-11-25WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESGuangzhou Baihua Co., Ltd4453997f-b885-ad2d-e063-6294a90a2c8e2025-11-24WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEVALU MERCHANDISERS, COc79540fe-b972-41a4-a215-e21e30b903d12025-11-24WarningsExact identifier
application number: M003
Lights SwabsticksISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.4435a4e6-46ae-f49b-e063-6394a90a1d9e2025-11-22WarningsExact identifier
application number: M003
FloraMedis Hand SanitizerHAND SANITIZERSichuan Pengtai Qifan Technology Co., Ltd4415ca9f-10b1-88f7-e063-6294a90a2e092025-11-21WarningsExact identifier
application number: M003
AMERIDERMBZKSHIELD LINE LLC440b711a-de12-2d28-e063-6394a90ae42a2025-11-20WarningsExact identifier
application number: M003
Recens FoamALCOHOLCertus Medical, Inc.ea384dfc-c894-3124-e053-2a95a90a81c22025-11-20WarningsExact identifier
application number: M003
Scent Theory Hand Sanitizer (Peach Peony, Dragonfruit Paradise, Coastal Fleur)ALCOHOLScent Theory Products LLC440f0a52-de0a-8f44-e063-6294a90a18b52025-11-20WarningsExact identifier
application number: M003
MK Alcohol Prep Pads LargeISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltdf1ff70d7-d0f2-45db-96e9-883b54c6e4412025-11-20WarningsExact identifier
application number: M003
Aero Care Handy Quat Antiseptic HandwashBENZALKONIUM CHLORIDEABC Compounding Co., Inc.ab015f59-160a-47d1-8d2f-fbe1b23177b32025-11-19WarningsExact identifier
application number: M003
FastALCOHOLABC Compounding Co., Inc.4f958247-5370-4250-b2eb-39faa97199392025-11-19WarningsExact identifier
application number: M003
Hydrogen Peroxide1169 HYDROGEN PEROXIDE SPRAYDynarex Corporation11854afb-db97-5a43-e063-6394a90aa39c2025-11-19WarningsExact identifier
application number: M003
Sani-SpritzALCOHOLABC Compounding Co., Inc.ac88c676-c396-4fb8-9e5c-77c726ed69d82025-11-19WarningsExact identifier
application number: M003
Osceola Supply Inc 6176CHLOROXYLENOLOSCEOLA SUPPLY, INC.a7dcc6b1-655d-41b3-ab97-913bc4aae01f2025-11-19WarningsExact identifier
application number: M003
AMERISILKBZKSHIELD LINE LLC43f9775c-0448-243e-e063-6294a90a9e222025-11-19WarningsExact identifier
application number: M003
Antibacterial Foamy Mango High Foaming Antiseptic Hand and Body WashCHLOROXYLENOLCarpet Rentals, Inc.a95b4d71-119e-4c3b-a280-09bd4533252b2025-11-18WarningsExact identifier
application number: M003
PetroleumWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)684ac03a-f9b1-412d-8ce5-819ca132dc342025-11-17WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLShandong Lianfa Medical Plastic Products CO.,LTD435fd382-d2f5-b07f-e063-6294a90a7d8a2025-11-14WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLShandong Lianfa Medical Plastic Products CO.,LTD43401653-b260-e86d-e063-6294a90abb3f2025-11-13WarningsExact 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