FDA.reportPublic FDA data

Private Label Antifungal Barrier Cream

Product NDC
60232-0009
11-digit product format
602320009
Labeler code
60232
Product ID
60232-0009_e08800a5-05ac-44be-8dc0-33ecb00aac38
Type
HUMAN OTC DRUG
Nonproprietary name
2% Miconazole Nitrate Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Swiss-American CDMO, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-11-22
Substance
MICONAZOLE NITRATE
Active strength
20 g/1000g
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
Private Label Antifungal Barrier Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 g/1000g

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
e74bddea-c1ac-4e4e-84bd-5a9defb85b2dAvailable on FDA.report

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
60232-0009-2Private Label Antifungal Barrier Cream60 g in 1 TUBECREAM604
60232-0009-4Private Label Antifungal Barrier Cream120 g in 1 TUBECREAM1204
60232-0009-5Private Label Antifungal Barrier Cream150 g in 1 TUBECREAM1504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60232-0009PRIVATE LABEL ANTIFUNGAL BARRIER CREAM (2% MICONAZOLE NITRATE CREAM) CREAM [SWISS-AMERICAN CDMO, LLC]3Current NDC, Legacy NDC, 3 package rows20231109_e74bddea-c1ac-4e4e-84bd-5a9defb85b2d.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 72 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Care Anti-ItchHYDROCORTISONEUnited Exchange Corp.8e4d46d8-7084-0666-e053-2995a90ad5202025-10-21WarningsExact identifier
application number: M017
Coralite Pain ReliefCAMPHOR, MENTHOL, METHYL SALICYLATEUnited Exchange Corp.69aec845-3d4c-d226-e053-2991aa0afd122025-10-21WarningsExact identifier
application number: M017
WHITE FLOWER ANALGESIC BALMCAMPHOR, MENTHOL AND METHYL SALICYLATEHOE HIN PAK FAH YEOW MANUFACTORY LTDf3e3b8b5-b12b-49ac-9318-b0c358b136e92025-10-21WarningsExact identifier
application number: M017
Mountain Ice Sports RecoveryMENTHOLMountainside Medical Equipment, Inc.98638529-3c17-436e-901f-c8aea52bdab62025-10-20WarningsExact identifier
application number: M017
Lip Clear Lysine PlusMENTHOL, UNSPECIFIED FORMQuantum, Inc.21a5b4fb-baed-4766-9820-5c6051c147202025-10-20WarningsExact identifier
application number: M017
Buzz Away Sting SootheMENTHOLQuantum, Inc.419e34ea-17b2-ec32-e063-6394a90a603d2025-10-20WarningsExact identifier
application number: M017
Family Care Anti-ItchHYDROCORTISONEUnited Exchange Corp.deb09e89-9794-89a7-e053-2a95a90abdf82025-10-20WarningsExact identifier
application number: M017
Numbing CreamMENTHOLFlexiGo Inc41571c8f-332b-f423-e063-6394a90a88972025-10-20WarningsExact identifier
application number: M017
Soothing Nerve TherapyMENTHOLWise Consumer Products40829d6b-5005-7ec9-e063-6294a90a970e2025-10-20WarningsExact identifier
application number: M017
Numbing CreamMENTHOLFlexiGo Inc4146fd51-b18c-393d-e063-6294a90a4d9a2025-10-20WarningsExact identifier
application number: M017
Lidocaine 4% Maximum OTC StrengthLIDOCAINECardinal Health 107, LLC975031df-d46d-4098-b1c0-1c0c92b419952025-10-20WarningsExact identifier
application number: M017
Cortizone 10 Intensive HealingHYDROCORTISONEChattem, Inc.bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c2025-10-20WarningsExact identifier
application number: M017
Sting relief padBENZOCAINE, ALCOHOLGuangdong Comfort Medical Products Co., Ltd.6e905065-10a9-1ded-e053-2a91aa0a46a12025-10-19WarningsExact identifier
application number: M017
CVS Cold and HotMENTHOLCVS Pharmacya44cec95-822a-40b6-e053-2995a90ae31c2025-10-17WarningsExact identifier
application number: M017
Sombra MaxSOMBRA MAXSombra Cosmetics Inc.41623a46-e6e7-907e-e063-6394a90afc4c2025-10-17WarningsExact identifier
application number: M017
POMADA DRAGON PAIN RELIEVINGCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATETELEVISA CONSUMER PRODUCTS USAc283291d-feaa-4f89-8fde-9e3957ea8b9f2025-10-17WarningsExact identifier
application number: M017
Ear Pain MDLIDOCAINE HYDROCHLORIDEEosera Inc78c4418f-7f0f-447f-a94f-d4c89a081af12025-10-17WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.414217c1-ff3a-b556-e063-6394a90aa5db2025-10-16WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.41422d04-160b-51b2-e063-6294a90ab2b22025-10-16WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.41427275-4c35-bbdf-e063-6294a90a14cf2025-10-16WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSNe74bddea-c1ac-4e4e-84bd-5a9defb85b2d4
998483miconazole nitrate 20 MG/ML Topical CreamSCDe74bddea-c1ac-4e4e-84bd-5a9defb85b2d4
998483miconazole nitrate 2 % Topical CreamSYe74bddea-c1ac-4e4e-84bd-5a9defb85b2d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60232-0009-26023200090260 g in 1 TUBE (60232-0009-2) 60 g2010-11-220000-00-00NoNoCurrent
60232-0009-460232000904120 g in 1 TUBE (60232-0009-4) 120 g2010-11-220000-00-00NoNoCurrent
60232-0009-560232000905150 g in 1 TUBE (60232-0009-5) 150 g2010-11-220000-00-00NoNoCurrent