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 99 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tylenol Precise Nighttime Pain RelievingCAMPHOR, MENTHOLKenvue Brands LLC2ef4fe16-0820-6aad-e063-6294a90a84492025-02-25WarningsExact identifier
application number: M017
LidoPro Pain ReliefCAPSAICIN AND LIDOCAINEPreferred Pharmaceuticals Inc.c259ef92-5d07-4590-adf1-3a106333eee02025-02-21WarningsExact identifier
application number: M017
Cortizone 10 Ultra Soothing Itch ReliefHYDROCORTISONEChattem, Inc.8a9e2d32-a65f-4253-8041-4146f4e3b7382025-02-21WarningsExact identifier
application number: M017
AVCOO Pain Relief Roll OnMENTHOLADP Health Limited420d8cdc-f47f-4d33-bf25-9033ff266c492025-02-19WarningsExact identifier
application number: M017
AVCOO Pain ReliefMENTHOLADP Health Limited700ce2cf-749e-40be-91c3-850d9b2168ca2025-02-19WarningsExact identifier
application number: M017
Sunburn Relief GelLIDOCAINE HCLJell Pharmaceuticals Pvt. Ltd2e7c49de-5438-4858-e063-6294a90ad98c2025-02-19WarningsExact identifier
application number: M017
VTROUY Tattoo Numbing CreamTATTOO NUMBING CREAMGuangzhou Zanming Trading Co., Ltd.2e899851-b3cd-0758-e063-6294a90afea82025-02-19WarningsExact identifier
application number: M017
Pomada Dragon Pain ReliefMENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND METHYL SALICYLATEGenomma Lab USA9d98f48b-6d88-4df9-9459-7cf7ba5de0442025-02-19WarningsExact identifier
application number: M017
Pain Relieving CreamHISTAMINE DIHYDROCHLORIDEMediapower, Inc. DBA Dr Newton's And Naturals9eeea033-ae87-4d83-85d0-b8fa653a08062025-02-19WarningsExact identifier
application number: M017
Sure Complete Confidence Antiperspirant Deodorant Aerosol, RegularALUMINUM CHLOROHYDRATESodalis USA, LLC7839cf53-dbd2-4dbb-a309-1581d51f8adc2025-02-18WarningsExact identifier
application number: M017
CANNA NUMB Roll OnLIDOCAINE HYDROCHLORIDE, MENTHOLCannanumb LLCc1eb0348-3b0e-4f1c-a46b-1ff4aa165fb42025-02-17WarningsExact identifier
application number: M017
Vaporizing Chest Rub 4 oz.CAMPHOR, EUCALYPTUS OIL, MENTHOLRejoice International Inc.7173b141-123e-6cd4-e053-2a95a90a86002025-02-12WarningsExact identifier
application number: M017
Vaporizing Chest Rub 4 oz. 3 pkCAMPHOR, EUCALYPTUS OIL, MENTHOLRejoice International Inc.71c186a1-8283-2482-e053-2995a90acc1f2025-02-12WarningsExact identifier
application number: M017
Roman SwipesBENZOCAINERoman Health Ventures Inc.7f0eac8c-7235-99d8-e053-2a91aa0a634e2025-02-12WarningsExact identifier
application number: M017
SANAR NATURAL-ARNICA ROLL ON ARNICA PAIN RELIEVING WITH CAMPHOREVI LABSEVI LABS2df7658d-83d3-41ac-e063-6294a90ab1dd2025-02-12WarningsExact identifier
application number: M017
Signature Care Medicated Pain Relief PatchLIDOCAINESafeway, Inc.2165a342-5f8b-78e0-e063-6394a90a06c42025-02-12WarningsExact identifier
application number: M017
CheeZheng Pain Relieveing PlasterCAMPHORTibet Cheezheng Tibetan Medicine Co. Ltd.abcebdf1-9037-4094-93e1-ce8f20b18ea72025-02-11WarningsExact identifier
application number: M017
Tibetree Pain Relieveing Medicated PlasterCAMPHORTibet Cheezheng Tibetan Medicine Co. Ltd4216bd48-5c62-4e87-adcc-67bf7152d64d2025-02-11WarningsExact identifier
application number: M017
AsperFlexLIDOCAINEAkron Pharma Inc.ab50525e-b534-452b-8c25-2992c0cbf8622025-02-10WarningsExact identifier
application number: M017
Olu Pain ManagementLIDOCAINE AND CAMPHOROlakino Therapeutics LLC2a41a621-c6f7-5819-e063-6394a90ae67d2025-02-07WarningsExact 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