FDA.reportPublic FDA data

PurKlenz

Product NDC
49436-291
Requested package NDC
49436-291-01
11-digit product format
494360291
Labeler code
49436
Product ID
49436-291_f51fb030-f10f-4b59-856e-d772f6d853fb
Type
HUMAN OTC DRUG
Nonproprietary name
CHLOROXYLENOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
PurKlenz Formulations Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-05-01
Substance
CHLOROXYLENOL
Active strength
2.949 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
PurKlenz
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROXYLENOL2.949 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
247396Internal RxNorm lookup
1537468Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9f1223a8-a256-46f0-b01d-01b32ca09d48Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49436-291-01PurKlenz900 mL in 1 BOTTLE, PLASTICLIQUID90014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLOROXYLENOLACTIVE INGREDIENT0F32U78V2QPURKLENZ (CHLOROXYLENOL) LIQUID [PURKLENZ FORMULATIONS INC.]5
CHLOROXYLENOLACTIVE MOIETY0F32U78V2QPURKLENZ (CHLOROXYLENOL) LIQUID [PURKLENZ FORMULATIONS INC.]5
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPURKLENZ (CHLOROXYLENOL) LIQUID [PURKLENZ FORMULATIONS INC.]5
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXPURKLENZ (CHLOROXYLENOL) LIQUID [PURKLENZ FORMULATIONS INC.]5
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUPURKLENZ (CHLOROXYLENOL) LIQUID [PURKLENZ FORMULATIONS INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPURKLENZ (CHLOROXYLENOL) LIQUID [PURKLENZ FORMULATIONS INC.]5
LANOLIN OILINACTIVE INGREDIENTOVV5IIJ58FPURKLENZ (CHLOROXYLENOL) LIQUID [PURKLENZ FORMULATIONS INC.]5
PPG-2 HYDROXYETHYL COCAMIDEINACTIVE INGREDIENT34N07GUJ3XPURKLENZ (CHLOROXYLENOL) LIQUID [PURKLENZ FORMULATIONS INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PURKLENZ (CHLOROXYLENOL) LIQUID [PURKLENZ FORMULATIONS INC.]5
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0PURKLENZ (CHLOROXYLENOL) LIQUID [PURKLENZ FORMULATIONS INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RPURKLENZ (CHLOROXYLENOL) LIQUID [PURKLENZ FORMULATIONS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49436-291PURKLENZ (CHLOROXYLENOL) LIQUID [PURKLENZ FORMULATIONS INC.]13Current NDC, Legacy NDC, 1 package rows20241202_9f1223a8-a256-46f0-b01d-01b32ca09d48.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 97 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol sterileISOPROPYL ALCOHOLCardinal Health, Incbb7c530f-5d80-4158-b715-09c1c837299d2024-11-21WarningsExact identifier
application number: M003
Alcohol sterileISOPROPYL ALCOHOLCardinal Health 200 LLC10135db9-f614-4511-96ac-faa6a02a1b612024-11-21WarningsExact identifier
application number: M003
BZK Antiseptic Swabsticks 4 TripleBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltdd9f35c14-2f5a-4e1a-bc2b-a7e1631342132024-11-21WarningsExact identifier
application number: M003
Povidone-lodine Swabsticks TriplePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd74e70ea9-640b-4295-a40f-56f65fca13002024-11-21WarningsExact identifier
application number: M003
MK Alcohol Prep Pads MediumISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd37f10b1f-b73c-4d71-91c2-1252f3d9d4ce2024-11-21WarningsExact identifier
application number: M003
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd1936d749-bf38-a433-e063-6294a90aba8c2024-11-21WarningsExact identifier
application number: M003
Maokang 10 Povidone IodinePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd7c17ce40-0358-44ff-aa60-53711666914b2024-11-21WarningsExact identifier
application number: M003
MK Alcohol Prep Pads MediumISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd11390854-9e72-40a2-9c89-3c29a585dced2024-11-21WarningsExact identifier
application number: M003
Instant Hand Sanitizeing WipeISOPROPANOL AND COMPOUND DOUBLE-STRANDED QUATERNARY AMMONIUM SALTSShandong Yayun Sanitary Products Co., Ltd.aa0dc01a-2c6b-7402-e053-2a95a90af6a22024-11-21WarningsExact identifier
application number: M003
Dynarex Povidone Iodine Prep SolutionPOVIDONE IODINE PREP SOLUTIONDynarex Corporation6bb4d55b-2be7-3549-e053-2a91aa0a2bb02024-11-20WarningsExact identifier
application number: M003
Dynarex Povidone Iodine Surgical ScrubPOVIDONE IODINE SURGICAL SCRUB SOLUTIONDynarex Corporation6f053e55-cbf6-9072-e053-2991aa0a2edd2024-11-20WarningsExact identifier
application number: M003
Dynarex GreenALCOHOLDynarex Corporation072572be-49dd-4594-bc40-b56db57ada5b2024-11-20WarningsExact identifier
application number: M003
Dynarex GreenCHLOROXYLENOLDynarex Corporation59b098d2-08de-4fdb-a209-ae226abf37d62024-11-20WarningsExact identifier
application number: M003
Baby WipesPROPYLENE GLYCOLShandong Yayun Sanitary Products Co., Ltd.aeb9a12c-955f-5030-e053-2995a90a2dd62024-11-20WarningsExact identifier
application number: M003
Pet wipesBENZALKONIUM CHLORIDEShandong Yayun Sanitary Products Co., Ltd.2764ea79-32d8-b7f6-e063-6394a90a55012024-11-20WarningsExact identifier
application number: M003
Premium Hand SanitizerETHANOLMCKESSON MEDICAL-SURGICAL INC.a9514466-e0c6-4792-984a-9f07d94ee8872024-11-18WarningsExact identifier
application number: M003
MARVEL BZK ANTISEPTIC WIPEBENZALKONIUM CHLORIDEAshtel Studios, Inc.93ed0bb4-834d-44ca-9c0a-20086fc09ab82024-11-18WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMcKesson Medical-Surgical Inc.98b0bcc2-539b-4471-ba98-bbe17bb881bd2024-11-15WarningsExact identifier
application number: M003
CVS Health Hydrogen Peroxide WipesHYDROGEN PEROXIDECVS PHARMACY, INC7a930a5e-5b69-428f-9cbb-d03dae1802952024-11-12WarningsExact identifier
application number: M003
First Aid Only Povidone-Iodine Prep PadPOVIDONE-IODINEAcme United Corporation509b6c8e-6a9f-2656-e054-00144ff8d46c2024-11-09WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
247396chloroxylenol 3 % Topical SolutionPSN9f1223a8-a256-46f0-b01d-01b32ca09d4814
1537468PURKlenz 3 % Topical SolutionPSN9f1223a8-a256-46f0-b01d-01b32ca09d4814
1537468chloroxylenol 30 MG/ML Topical Solution [Purklenz]SBD9f1223a8-a256-46f0-b01d-01b32ca09d4814
247396chloroxylenol 30 MG/ML Topical SolutionSCD9f1223a8-a256-46f0-b01d-01b32ca09d4814
247396chloroxylenol 3 % Topical SolutionSY9f1223a8-a256-46f0-b01d-01b32ca09d4814
1537468Purklenz 3 % Topical SolutionSY9f1223a8-a256-46f0-b01d-01b32ca09d4814
1537468Purklenz 30 MG/ML Topical SolutionSY9f1223a8-a256-46f0-b01d-01b32ca09d4814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49436-291-0149436029101900 mL in 1 BOTTLE, PLASTIC (49436-291-01) 900 ml2012-05-010000-00-00NoNoCurrent