FDA.reportPublic FDA data

Relispray Antifungal Liquid

Product NDC
46063-810
11-digit product format
460630810
Labeler code
46063
Product ID
46063-810_fc49d7c5-107d-4fa8-be6c-dca84e98ece2
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Midas-Care Pharmaceuticals Pvt. Ltd.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-01
Substance
TOLNAFTATE
Active strength
.01 g/g
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
Relispray Antifungal Liquid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE.01 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06KB629TKVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313421Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6522ad59-f810-408c-a9f9-9359d79302ceAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46063-810-12Relispray Antifungal Liquid128 g in 1 CANAEROSOL, SPRAY1282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46063-810RELISPRAY ANTIFUNGAL LIQUID (TOLNAFTATE) AEROSOL, SPRAY [MIDAS-CARE PHARMACEUTICALS PVT. LTD.]2Current NDC, Legacy NDC, 1 package rows20241220_6522ad59-f810-408c-a9f9-9359d79302ce.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 49 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Evercare Antifungal Treatment Super Absorbent PowderMICONAZOLE NITRATEPANEFFORT, LLCf91910f3-b461-43a4-9120-fda69483fffa2023-10-26WarningsExact identifier
application number: M005
Thera plus Antifungal ClotrimazoleCLOTRIMAZOLEFOURSTAR GROUP USA, INC.1265be99-8922-4b76-bd63-19bfb42c38962023-10-26WarningsExact identifier
application number: M005
Thera plus Antifungal TolnaftateTOLNAFTATEFOURSTAR GROUP USA, INC.c628dda8-7a6d-5f3a-e053-2995a90a35f82023-10-26WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltde1789944-3a41-4c86-b173-3a6993ae21412023-10-23WarningsExact identifier
application number: M005
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltd14f2a1dd-92c2-49e8-9fa0-a9d88e8c530d2023-10-23WarningsExact identifier
application number: M005
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltdb82cea56-b09f-411d-a6cf-c53b3ce0e3b62023-10-23WarningsExact identifier
application number: M005
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd78131b57-1ffc-4eb8-821e-f7bb73300fe92023-10-23WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltdeb30e5de-9074-4760-8e92-e1d1c127227d2023-10-23WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltd0bd3de76-b726-41f1-87bc-14ab8a1eca8e2023-10-23WarningsExact identifier
application number: M005
Povidone Iodine Prep PadPOVIDONE-IODINEJianerkang Medical Co., Ltdbe85ec5b-eb49-4f1a-a87d-5c9705a20f232023-10-22WarningsExact identifier
application number: M005
EVERLIT CARE Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.579c1ab5-50b4-4b5a-a189-c1e2827d0c3a2023-10-14WarningsExact identifier
application number: M005
Micomitin AntifungalCLOTRIMAZOLEPureTek Corporationdd05f5f9-2412-1295-e053-2995a90acb962022-02-14WarningsExact identifier
application number: M005
MicatinMICONAZOLE NITRATEWellSpring Pharmaceutical Corporation96c56ba1-c3a8-48ce-ab58-550959485e3c2016-04-07WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313421tolnaftate 1 % Topical SprayPSN6522ad59-f810-408c-a9f9-9359d79302ce2
313421tolnaftate 10 MG/ML Topical SpraySCD6522ad59-f810-408c-a9f9-9359d79302ce2
313421tolnaftate 1 % Topical SpraySY6522ad59-f810-408c-a9f9-9359d79302ce2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46063-810-1246063081012128 g in 1 CAN (46063-810-12) 128 g2022-03-010000-00-00NoNoCurrent