FDA.reportPublic FDA data

Castellani Paint

Product NDC
58980-820
11-digit product format
589800820
Labeler code
58980
Product ID
58980-820_6e490b46-1794-4d44-95b6-9b4580833577
Type
HUMAN OTC DRUG
Nonproprietary name
Phenol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Stratus Pharamceuticals
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-09-15
Substance
PHENOL
Active strength
15 mg/mL
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
Castellani Paint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOL15 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
339NCG44TVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199858Internal RxNorm lookup
309033Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
74192c0e-3c73-4ab0-96d1-1917cbd6777aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58980-820-10Castellani Paint29.57 mL in 1 BOTTLELIQUID29.573
58980-820-10Castellani Paint1 in 1 BOXLIQUID13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58980-820-10ML - Milliliter58980-82044ce42ec-4cd6-41ce-b1ab-30ab7b5f328f12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PhenolACTIVE INGREDIENT339NCG44TVCASTELLANI PAINT (PHENOL) LIQUID [STRATUS PHARAMCEUTICALS]1
PhenolACTIVE MOIETY339NCG44TVCASTELLANI PAINT (PHENOL) LIQUID [STRATUS PHARAMCEUTICALS]1
ACETONEINACTIVE INGREDIENT1364PS73AFCASTELLANI PAINT (PHENOL) LIQUID [STRATUS PHARAMCEUTICALS]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCASTELLANI PAINT (PHENOL) LIQUID [STRATUS PHARAMCEUTICALS]1
RESORCINOLINACTIVE INGREDIENTYUL4LO94HKCASTELLANI PAINT (PHENOL) LIQUID [STRATUS PHARAMCEUTICALS]1
WaterINACTIVE INGREDIENT059QF0KO0RCASTELLANI PAINT (PHENOL) LIQUID [STRATUS PHARAMCEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58980-820CASTELLANI PAINT (PHENOL) LIQUID [STRATUS PHARAMCEUTICALS]2Current NDC, Legacy NDC, 2 package rows20171024_74192c0e-3c73-4ab0-96d1-1917cbd6777a.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
309033Castellani Paint 1.5 % Topical SolutionPSN74192c0e-3c73-4ab0-96d1-1917cbd6777a3
199858phenol 1.5 % Topical SolutionPSN74192c0e-3c73-4ab0-96d1-1917cbd6777a3
309033phenol 15 MG/ML Topical Solution [Castellani Paint]SBD74192c0e-3c73-4ab0-96d1-1917cbd6777a3
199858phenol 15 MG/ML Topical SolutionSCD74192c0e-3c73-4ab0-96d1-1917cbd6777a3
309033Castellani Paint 1.5 % Topical SolutionSY74192c0e-3c73-4ab0-96d1-1917cbd6777a3
309033Castellani Paint 15 MG/ML Topical SolutionSY74192c0e-3c73-4ab0-96d1-1917cbd6777a3
199858phenol 1.5 % Topical SolutionSY74192c0e-3c73-4ab0-96d1-1917cbd6777a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58980-820-10589800820101 BOTTLE in 1 BOX (58980-820-10) / 29.57 mL in 1 BOTTLE1 bottle2017-09-150000-00-00NoNoCurrent