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 114 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Henry Schein Povidone-Iodine SwabsticksPOVIDONE-IODINEHenry Schein, Inc.5854f241-6cfc-4e5a-ba72-92dd0703f7282023-10-13WarningsExact identifier
application number: M003
DawnMist Alcohol Hand SanitizerALCOHOLDukal LLCa2df96a9-8514-6839-e053-2a95a90a94172023-10-13WarningsExact identifier
application number: M003
DUKAL STING RELIEF PADBENZOCAINEDukal LLC67c1ddc7-8fde-4431-84cb-f757682d5f3e2023-10-13WarningsExact identifier
application number: M003
First Aid Only First Aid/BurnLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDEAcme United Corporation07245b54-b193-178e-e063-6394a90a25812023-10-09WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk originalETHYL ALCOHOLRejoice International Corp.06dc1730-216a-8b4d-e063-6294a90a41842023-10-04WarningsExact identifier
application number: M003
Hand sanitizer 1.8oz with extra clip originalETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.06dcf8dc-0831-475e-e063-6394a90a9fef2023-10-04WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk originalETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.06dd2427-097c-b0fa-e063-6294a90a4f822023-10-04WarningsExact identifier
application number: M003
Hand sanitizer 1.8oz with extra clip originalETHYL ALCOHOLRejoice International Corp.06da0cc1-95f2-4f88-e063-6394a90a25ea2023-10-03WarningsExact identifier
application number: M003
First Aid Antiseptic Alcohol Pads Isopropyl Alcohol 70 Rite AidISOPROPYL ALCOHOLRite Aid Corporationaa0df5fe-62d1-407d-b8f9-a7fd9473d5692023-10-02WarningsExact identifier
application number: M003
Foaming Instant Hand Sanitizer with AloeETHANOLMCKESSON MEDICAL-SURGICAL INC.5c1f69b7-c8d8-477c-b614-47a3287b0e4c2023-06-05WarningsExact identifier
application number: M003
Bactine Max DryLIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation466404cd-c46a-4944-b1ac-3b3b17f436a12022-12-27WarningsExact identifier
application number: M003
Povidone-Iodine PadPOVIDONE-IODINEShandong Haiyan Medical Manufacture Co., Ltd.c9187a07-92d5-15ac-e053-2995a90af4cb2022-03-19WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLShandong Haiyan Medical Manufacture Co., Ltd.1a117840-22d0-4a88-b1a6-e43162a444ab2022-03-19WarningsExact identifier
application number: M003
FIRSTAR BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.28591a97-9291-48c8-a8e3-c419180331b32021-07-06WarningsExact identifier
application number: M003
Bactine MaxBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation28e8a311-20a4-45a1-8d5d-ca42b101c2752021-02-24WarningsExact identifier
application number: M003
Hand Sanitizer Lemon 2ozALCOHOLNingbo Rejoice Internationalb0a4159a-cb07-4ce6-e053-2995a90a76e72020-10-02WarningsExact identifier
application number: M003
Sanix Alcohol Hand RubALCOHOLTopiderm, Inca4fbb714-4f20-400a-ab98-f1c8807ce6fc2020-03-24WarningsExact 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