FDA.reportPublic FDA data

Relispray Antifungal Powder

Product NDC
46063-552
11-digit product format
460630552
Labeler code
46063
Product ID
46063-552_692ad959-7088-4fe5-9ff7-66b1e26f517f
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Midas-Care Pharmaceuticals Pvt. Ltd.
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-03-01
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE
Active strength
0 g/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct46063-552IInactivated by FDA2026-10-15
excluded packagepackage46063-55246063-552-12IInactivated by FDA2026-10-15

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46063-552-12Relispray Antifungal Powder128 g in 1 CANAEROSOL, SPRAY1282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46063-552RELISPRAY ANTIFUNGAL POWDER (MICONAZOLE NITRATE) AEROSOL, SPRAY [MIDAS-CARE PHARMACEUTICALS PVT. LTD.]2Legacy NDC, 1 package rows20241220_93434d3e-6fe4-4fe0-be4f-573d183bf527.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998428miconazole nitrate 2 % Powder SprayPSN93434d3e-6fe4-4fe0-be4f-573d183bf5272
998428miconazole nitrate 0.02 MG/MG Powder SpraySCD93434d3e-6fe4-4fe0-be4f-573d183bf5272
998428miconazole nitrate 2 % Powder SpraySY93434d3e-6fe4-4fe0-be4f-573d183bf5272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46063-552-1246063055212128 g in 1 CAN (46063-552-12) 128 g2022-03-010000-00-00NoNoCurrent