FDA.reportPublic FDA data

SUNMARK MICONAZOLE NITRATE

Product NDC
49348-689
11-digit product format
493480689
Labeler code
49348
Product ID
49348-689_3b276d84-5847-1694-e063-6294a90a4609
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Strategic Sourcing Services LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1991-10-01
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
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
SUNMARK MICONAZOLE NITRATE
Brand name suffix
antifungal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

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
7c15d95a-5b89-4789-8c91-3f61d7ec7707Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49348-689-722025-07-30C16284748780-13b156c62-3319-fb37-e063-e6dba90a4e07sunmark ™ antifungal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-689-72SUNMARK MICONAZOLE NITRATEantifungal30 g in 1 TUBECREAM305
49348-689-72SUNMARK MICONAZOLE NITRATEantifungal1 in 1 CARTONCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-689-72GM - Gram49348-689ae015f1f-68b8-4209-b295-89bdbc8d553712013-02-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1KSUNMARK ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [MCKESSON]1
MiconazoleACTIVE MOIETY7NNO0D7S5MSUNMARK ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [MCKESSON]1
apricot kernel oilINACTIVE INGREDIENT54JB35T06ASUNMARK ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [MCKESSON]1
benzoic acidINACTIVE INGREDIENT8SKN0B0MIMSUNMARK ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [MCKESSON]1
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KSUNMARK ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [MCKESSON]1
glycol stearateINACTIVE INGREDIENT0324G66D0ESUNMARK ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [MCKESSON]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPSUNMARK ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [MCKESSON]1
polyethylene glycol 300INACTIVE INGREDIENT5655G9Y8AQSUNMARK ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [MCKESSON]1
waterINACTIVE INGREDIENT059QF0KO0RSUNMARK ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [MCKESSON]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-689SUNMARK MICONAZOLE NITRATE ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [STRATEGIC SOURCING SERVICES LLC]4Current NDC, Legacy NDC, 2 package rows20241211_7c15d95a-5b89-4789-8c91-3f61d7ec7707.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 45 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hongo KillerUNDECYLENIC ACIDEfficient Laboratories Inc5c433182-0c0c-4a0a-8dd8-a14f60e524252024-10-14WarningsExact identifier
application number: M005
Miconazole nitrateANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAYMeijer Distribution Inc6c2ebe17-994d-41c8-bacb-87b6a63b2db42024-10-14WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGALMcKesson8dcca44a-16c7-7262-e053-2a95a90a1b232024-10-10WarningsExact identifier
application number: M005
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Incebc565bb-e56c-43ba-a5cb-d2fad2aafc4a2024-10-07WarningsExact identifier
application number: M005
Micotrin ALTOLNAFTATEPureTek Corporationcc0fba1e-82c5-42fd-e053-2995a90af2492024-10-02WarningsExact identifier
application number: M005
Mycozyl ALTOLNAFTATEPureTek Corporationb82c9a8a-f6f1-dca6-e053-2995a90a47f92024-10-02WarningsExact identifier
application number: M005
MY MEDIC SUPER SANITIZERALCOHOLNantong Health & Beyond Hygienic Products Inc.f19971b1-2aeb-4c37-82b0-9525026cff7a2024-10-02WarningsExact identifier
application number: M005
Micotrin ACCLOTRIMAZOLEPureTek Corporationcbe4dd18-c9ef-a4e4-e053-2995a90a52892024-10-01WarningsExact identifier
application number: M005
Micotrin APMICONAZOLE NITRATEPureTek Corporationcbe3d495-cdee-2343-e053-2a95a90a5b822024-10-01WarningsExact identifier
application number: M005
Mycozyl ACCLOTRIMAZOLEPureTek Corporationb676d257-3cfd-7f24-e053-2995a90a546e2024-10-01WarningsExact identifier
application number: M005
Mycozyl APMICONAZOLE NITRATEPureTek Corporationb3c46a30-7ff2-0dc4-e053-2995a90aa5712024-10-01WarningsExact identifier
application number: M005
AOSI HEALTHCARE HAND SANITIZERALCOHOLNantong Health & Beyond Hygienic Products Inc.59d631d0-d8ae-45a8-a7a9-26de9cc427b32024-09-25WarningsExact identifier
application number: M005
Clotrimazole 1%CLOTRIMAZOLEDabur India Limited22916978-303f-e62a-e063-6394a90a21002024-09-20WarningsExact identifier
application number: M005
Mentholatum Heel Revival CreamMENTHOLATUM HEEL REVIVAL CREAMThe Mentholatum Company21b643c2-eb6e-8939-e063-6394a90aaeac2024-09-09WarningsExact identifier
application number: M005
VAGISTEN-V 7 DAYMICONAZOLE NITRATEOPMX LLCa5bfa501-5ae1-4434-bc31-995d0665b99e2024-09-04WarningsExact identifier
application number: M005
COTTON ON FOUNDATION Tropical Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.3645359c-06a2-4b97-b982-c54e4a0b8cda2024-09-04WarningsExact identifier
application number: M005
COTTON ON FOUNDATION Coastal Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.645c09dc-15a4-481f-a605-f12fb8f8e9bd2024-09-04WarningsExact identifier
application number: M005
Publix Athletic FootCLOTRIMAZOLE 1%PUBLIX SUPER MARKETS, INC.d9f99680-5636-4136-a7c6-c3643339e6b42024-08-02WarningsExact identifier
application number: M005
ANTIFUNGAL FOOTTOLNAFTATEUniversal Distribution Center LLC10579848-5793-4d72-ad5f-62d191c710742024-07-16WarningsExact identifier
application number: M005
MY MEDIC SUPER SANITIZERETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.cd8f4ccd-b75e-4de0-87c0-150dfb6e0bf32024-07-02WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN7c15d95a-5b89-4789-8c91-3f61d7ec77075
998483miconazole nitrate 20 MG/ML Topical CreamSCD7c15d95a-5b89-4789-8c91-3f61d7ec77075
998483miconazole nitrate 2 % Topical CreamSY7c15d95a-5b89-4789-8c91-3f61d7ec77075

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-689-72493480689721 TUBE in 1 CARTON (49348-689-72) / 30 g in 1 TUBE1 tube1991-10-010000-00-00NoNoCurrent