FDA.reportPublic FDA data

DRAVYNOR BALANITIS RELIEF Cream

Product NDC
87786-021
11-digit product format
877860021
Labeler code
87786
Product ID
87786-021_56b76a52-0744-4fe6-e063-6294a90a98a8
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate 2% BALANITIS RELIEF Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Wenzhou Yuyuan Pharmaceutical Co., Ltd.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-16
Substance
MICONAZOLE NITRATE
Active strength
2 g/100mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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
DRAVYNOR BALANITIS RELIEF Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VW4H1CYW1KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998483Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
56b76a52-0743-4fe6-e063-6294a90a98a8Available on FDA.report

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 24 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FortiniaCLOTRIMAZOLEThe Podiatree Company60ba6f8a-8617-d4f6-e053-2991aa0a4a712026-01-08WarningsExact identifier
application number: M005
RoyceDerm Anti fungal RELIEF creamSALICYLIC ACID 2%RoyceDerm LLC47ec6277-e40f-af82-e063-6294a90ac8c12026-01-08WarningsExact identifier
application number: M005
BBlove ALCOHOL WIPESBBLOVE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD1a451616-b16e-8aa7-e063-6294a90a26a12026-01-07WarningsExact identifier
application number: M005
Wet wipesWET WIPESShenzhen Shierjie Biological Engineering Co., LTD273b3ae2-6dec-31a4-e063-6294a90aca892026-01-07WarningsExact identifier
application number: M005
Bee Venom Fungal Nail Treatment LiquidBEE VENOM FUNGAL NAIL TREATMENTShenzhen Earth Surface Trading Co., Ltd.47c37468-ba5c-0d11-e063-6294a90ac5542026-01-06WarningsExact identifier
application number: M005
ProBliva Anti Fungal Shampoo.ANTIFUNGALCAVTECH HOLDING LLC47af9ff8-5d5c-4524-e063-6394a90ac91f2026-01-05WarningsExact identifier
application number: M005
Beauty Creations Pink Halo Hand Sanitizer MistETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.dda9f4cb-e431-4164-be61-0daf1a86d10f2026-01-04WarningsExact identifier
application number: M005
FUNGAL NAIL PATCHESUNDECYLENIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.477c971d-829f-5040-e063-6394a90a41e42026-01-03WarningsExact identifier
application number: M005
Nail Renovar PlusTOLNAFTATESOHM, Inc2c09925c-e63e-4d9b-8d76-b06bd2cba26c2026-01-02WarningsExact identifier
application number: M005
Natural Sense Full Body Cleansing TowelCLEANSING TOWELDr. Natural LLC4742eec4-b7a3-2c89-e063-6294a90a19fc2025-12-31WarningsExact identifier
application number: M005
Lasolex AGMICONAZOLE NITRATEPuretek Corporation4411142f-a8ec-c8c2-e063-6394a90aa25c2025-12-31WarningsExact identifier
application number: M005
Hermon Antifungal Stick1% CLOTRIMAZOLEBeautivity LLC474a5783-4488-034e-e063-6294a90a5de32025-12-31WarningsExact identifier
application number: M005
SnugZ Hand Sanitizing WipesHAND SANITIZING WIPESSnugZ/USA, LLCc5d9122a-2c67-2387-e053-2a95a90a2c3a2025-12-29WarningsExact identifier
application number: M005
Clotrimazole (Topical Solution), 1%CLOTRIMAZOLEPuro Pharma Inc.cb424fa8-3ed5-45cd-b03f-64675584b34e2025-12-27WarningsExact identifier
application number: M005
CLOTRIMAZOLECLOTRIMAZOLEGRAXCELL PHARMACEUTICAL, LLC.5f8ca6ad-cb25-1abf-e053-2a91aa0aca992025-12-25WarningsExact identifier
application number: M005
CuraNails Antifungal PenUNDECYLENIC ACID 25%Quality Discount Inc.3e641d36-72f6-4682-bd31-f7cd04d857f22025-12-25WarningsExact identifier
application number: M005
Opti-Nail 2-in-1TOLNAFTATEKramer Laboratoriesbc8a5492-8bd0-4c80-a270-e4958aeb5ed62025-12-23WarningsExact identifier
application number: M005
ProBliva Medicated Anti FungalANTIFUNGALCAVTECH HOLDING LLC46852aea-028c-71c2-e063-6394a90a80552025-12-22WarningsExact identifier
application number: M005
Terthon Clotrimazole 1% Antifungal CreamCLOTRIMAZOLE 1%SOLALIA LLC468f1b1b-f67d-8b98-e063-6294a90a7f452025-12-22WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEGranules USA, Inc.6e63e29a-eb50-1790-e053-2a91aa0a36162025-12-22WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87786-021-018778600210130 mL in 1 BOTTLE (87786-021-01) 30 ml2026-07-16NoNoCurrent