FDA.reportPublic FDA data

PurKlenz

Product NDC
49436-291
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

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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-0849436-291-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0849436-291-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0849436-291-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0349436-291-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0349436-291-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0349436-291-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0949436-291-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0949436-291-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0949436-291-02557ba5c1ecfa…9c80585c8c6e…

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 90 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DERMADIVE ULTRACARE - TETRAIDBENZALKONIUM CHLORIDEReleaf Technologies LLC025c0b33-73ca-334b-e063-6394a90ad6682025-01-09WarningsExact identifier
application number: M003
Drs. pharmacy triple antibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENTOL PHARMA TECH, LLCbb730976-0045-c0ae-e053-2a95a90af34e2025-01-09WarningsExact identifier
application number: M003
Drs. Antibiotic BacitracinBACITRACINOL PHARMA TECH, LLCc26493c4-0bc1-5fdc-e053-2995a90a81e62025-01-09WarningsExact identifier
application number: M003
Drs. Pharmacy Triple Antibiotic PlusBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEOL PHARMA TECH, LLC Drs PHARMACYd037bfb8-0d8c-4eda-e053-2995a90ae1f22025-01-09WarningsExact identifier
application number: M003
BACTINE MAXBACTINE MAX WOUND WASHWellSpring Pharmaceutical Corporation39b26c28-93e0-41a9-8018-f73525ebc0152025-01-08WarningsExact identifier
application number: M003
sterilePOVIDONE-IODINEAsia Dynamics Inc., d/b/a ADI Medical0658a0c8-f5ec-b380-e063-6394a90afff52025-01-08WarningsExact identifier
application number: M003
Betadine Surgical ScrubPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.1ad39e11-ea1e-44a4-8224-93f8135436c22025-01-06WarningsExact identifier
application number: M003
First Aid AntisepticBENZALKONIUM CHLORIDEWater-Jel Technologies2b3cb958-c0c4-47fd-8338-7c7821135f2b2025-01-06WarningsExact identifier
application number: M003
Instant Hand SanitizerALCOHOLWater-Jel Technologies54e62104-8076-41db-afe5-6dc5c3563acc2025-01-06WarningsExact identifier
application number: M003
Betadine SolutionPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.41891599-420e-48d2-8e31-d28a2209e3832025-01-06WarningsExact identifier
application number: M003
Signature Care Alcohol Prep PadISOPROPYL ALCOHOLBetter Living Brands LLCadc87331-1aa1-3457-e053-2a95a90a7eb12025-01-03WarningsExact identifier
application number: M003
Alcohol Extra-ThickISOPROPYL ALCOHOLMeijer Distribution Inc0b02643d-ea14-4877-ae9c-f0749d1b2d102025-01-03WarningsExact identifier
application number: M003
Premier ValueISOPROPYL ALCOHOLPharmacy Value Alliance, LLCd2baa47e-9673-7f23-e053-2a95a90adcb72025-01-03WarningsExact identifier
application number: M003
CVS Alcohol PrepISOPROPYL ALCOHOLCVS Pharmacy88f761c1-cb50-4edc-9a54-43444378eff72025-01-03WarningsExact identifier
application number: M003
Sterile AlcoholISOPROPYL ALCOHOLChain Drug Marketing Association Inc55922632-3768-4450-9389-ba7d7d91f2c92025-01-03WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLCASAD Company, Inc1e314157-c64e-492a-89ad-2b28831d551d2025-01-03WarningsExact identifier
application number: M003
BetadinePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.00002127-02bc-4c66-b0c3-ca29d8224afc2025-01-02WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER COTTON CANDYALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d02e4d6-8751-b5bc-e063-6394a90a9d972025-01-01WarningsExact identifier
application number: M003
COVISIDE HAND SANITIZERISOPROPYL ALCOHOLCREAGEN INCa9f07fcd-4d5c-362c-e053-2a95a90a2e792024-12-30WarningsExact identifier
application number: M003
KEEPAN ABENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.a30679d5-5507-499d-9d9f-498095fd32ac2024-12-30WarningsExact 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
49436-291-02494360291023780 mL in 1 BOTTLE (49436-291-02) 3780 ml2012-05-010000-00-00NoNoCurrent
49436-291-03494360291031000 PACKET in 1 BOX (49436-291-03) > 3.5 mL in 1 PACKET1000 packet2012-05-010000-00-00NoNoCurrent
49436-291-0549436029105500 mL in 1 BOTTLE, PLASTIC (49436-291-05) 500 ml2012-05-010000-00-00NoNoCurrent