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 46 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEASTONEA LABS PRIVATE LIMITEDe66191a6-0c3c-7319-e053-2a95a90aae842024-06-25WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLEA-S Medication Solutionsb63a3fe5-5684-41bc-ad6c-69c54e5b942d2024-06-20WarningsExact identifier
application number: M005
THERA Antifungal BodyMICONAZOLE NITRATEMcKesson Medical-Surgical Inc.31096041-28c9-4b16-bbd1-dbadefd375052024-06-14WarningsExact identifier
application number: M005
Antifungal BodyMICONAZOLE NITRATEMcKesson4fb9aece-0baa-475e-e054-00144ff8d46c2024-06-13WarningsExact identifier
application number: M005
Secura ProtectiveZINC OXIDESmith & Nephew Medical Ltdb077aa64-49a3-42ee-abb3-88f833635b932024-06-12WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLENuCare Pharmaceuticals,Inc.627375fb-2f20-16bc-e053-2a91aa0a15422024-06-06WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLECardinal Health 110 dba LEADER199df107-3384-6e03-e063-6294a90afc382024-05-29WarningsExact identifier
application number: M005
FemmesilCLOTRIMAZOLEAidance Skincare & Topical Solutions, LLCefddad82-9dc7-4cd9-b33c-7e85f30d992e2024-05-24WarningsExact identifier
application number: M005
Anti-FungalMICONAZOLE NITRATEUniversal Distribution Center LLC8f316b0d-d308-4ae6-82c4-39bb0d1d474e2024-05-21WarningsExact identifier
application number: M005
CANESPIESTOLNAFTATEOPMX LLCe2f9eedc-3c43-416b-85b5-ba07fb5fb4db2024-05-17WarningsExact identifier
application number: M005
Up and Up AntifungalTOLNAFTATE 1%Target Corporation8f54c8c7-6771-49c3-b429-53aa6df54dc52024-05-08WarningsExact identifier
application number: M005
Up and Up Athletes FootCLOTRIMAZOLE 1%Target Corporation52b61859-11ae-4990-aa0c-9dc1dd00adf42024-05-08WarningsExact identifier
application number: M005
ADI Medical PVP-I Pouch, FoilPOVIDONE-IODINEAsia Dynamics Inc., d/b/a ADI Medical0e8baf24-0c67-5511-e063-6394a90acaa12024-05-02WarningsExact identifier
application number: M005
Caseys Antimicrobial Hand SanitizerETHYL ALCOHOLNavajo Manufacturing Company Inc.78863024-390c-4ff9-8ed6-02af07902a302024-04-29WarningsExact identifier
application number: M005
MQUPIN Liquid Fungal Nail TreatmentLIQUID FUNGAL NAIL TREATMENTZhengzhou Miaoqi Medical Technology Co., Ltd.14782f8c-3b29-1d88-e063-6294a90ac3e42024-03-25WarningsExact identifier
application number: M005
ETADERM Advanced Antifungal SupportUNDECYLENIC ACIDNUEPHASE LLCadb12a1c-ece9-4a59-a62c-89d212c57e6f2024-03-13WarningsExact identifier
application number: M005
Dermachange JockMICONAZOLE NITRATEPrivate label Beauty and Wellness12eef049-76c9-1450-e063-6394a90a00ea2024-03-05WarningsExact identifier
application number: M005
Clotrimazole AntifungalCLOTRIMAZOLETrifecta Pharmaceuticals USA, LLC.11bf50db-552e-0a39-e063-6394a90af60d2024-02-19WarningsExact identifier
application number: M005
TOLNAFTATE ANTIFUNGALTOLNAFTATEBryant Ranch Prepackfbbd159c-217e-46d3-963c-ba0bd1e9bbe82024-01-29WarningsExact identifier
application number: M005
Target Jock ItchCLOTRIMAZOLE 1%Target Corporationf44d4c44-99d1-413f-b9c3-8330bdd21abb2024-01-17WarningsExact 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