FDA.reportPublic FDA data

Antifungal Cream

Product NDC
68001-481
11-digit product format
680010481
Labeler code
68001
Product ID
68001-481_097d4e93-7f8b-53f8-e063-6294a90a4e40
Type
HUMAN OTC DRUG
Nonproprietary name
antifungal
Dosage form
CREAM
Route
TOPICAL
Labeler
BluePoint Laboratories
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-01
Substance
MICONAZOLE NITRATE
Active strength
2 g/100g
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
Antifungal Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE2 g/100g

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
b564f971-2a9b-a605-e053-2995a90aee69Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-481-45Antifungal Cream1 in 1 CARTONCREAM13
68001-481-45Antifungal Cream28.4 g in 1 TUBECREAM28.43
68001-481-47Antifungal Cream42.5 g in 1 TUBECREAM42.53
68001-481-47Antifungal Cream1 in 1 CARTONCREAM13
68001-481-48Antifungal Cream1 in 1 CARTONCREAM13
68001-481-48Antifungal Cream14.2 g in 1 TUBECREAM14.23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-481-45GM - Gram68001-481ba768649-6724-4ed0-ad34-e2e98517b08712022-10-06
68001-481-47GM - Gram68001-4817776222a-d933-4b64-9921-fc6ed192589f12022-10-06
68001-481-48GM - Gram68001-4819fa4ec38-492c-43b4-8766-50e1808e083812022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-481ANTIFUNGAL CREAM (ANTIFUNGAL) CREAM [BLUEPOINT LABORATORIES]3Current NDC, Legacy NDC, 6 package rows20231118_b564f971-2a9b-a605-e053-2995a90aee69.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 3 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WISH HAND SANITIZER Strawberry MuskALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA59143edb-41fe-0a1f-e063-6394a90a81a52026-08-15WarningsExact identifier
application number: M005
WISH HAND SANITIZER Rose WoodsALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58fb4491-2918-c486-e063-6394a90a621f2026-08-14WarningsExact identifier
application number: M005
VXGXO antifungal with tea tree oilTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd58fd67c5-c985-13a7-e063-6294a90a40fb2026-08-14WarningsExact identifier
application number: M005
Charmpoo ANTIFUNGAL BODY CreamMICONAZOLE NITRATE 2% ANTIFUNGAL BODY CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.58ff4779-83a7-afe2-e063-6294a90a9f9a2026-08-14WarningsExact identifier
application number: M005
TEATREEOILANTIFUNGALUNDECYLENIC ACID AND ZINC UNDECYLENATEFoshan Chancheng District Xuntou Electronic Commerce Co., Ltd5900904f-cf51-4398-e063-6394a90aca6c2026-08-14WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEYYBA CORP58f1707a-579b-1e06-e063-6294a90a5a9f2026-08-13WarningsExact identifier
application number: M005
WISH HAND SANITIZER Mango Coconut CreamALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58faa781-520b-92fa-e063-6294a90a9ecf2026-08-13WarningsExact identifier
application number: M005
Hecila ANTIFUNGAL NAILUNDECYLENIC ACID 25% ANTIFUNGAL NAILWenzhou Yuyuan Pharmaceutical Co., Ltd.58c117cc-e039-86f6-e063-6394a90af18f2026-08-12WarningsExact identifier
application number: M005
TOTCLEAR NAIL RENEWALUNDECYLENIC ACIDGOOD BRIDGE LLC93605e22-920d-43c3-bb2b-6e3116a19f5e2026-08-12WarningsExact identifier
application number: M005
TOTCLEAR NAIL RENEWALUNDECYLENIC ACIDGOOD BRIDGE LLCfde7d6ea-1b44-4a88-820a-0f2e033727e12026-08-11WarningsExact identifier
application number: M005
XBOFPEN MULTI-PURPOSE TREATMENTTOLNAFTATE 1% MULTI-PURPOSE TREATMENTWenzhou Yuyuan Pharmaceutical Co., Ltd.58c2f50c-9c9e-4989-e063-6394a90abb212026-08-11WarningsExact identifier
application number: M005
RoyceDerm Athletes foot antifungal .cream.MICONAZOLE NITRATE 2%RoyceDerm LLC58d23aa0-497e-4ece-e063-6294a90aef662026-08-11WarningsExact identifier
application number: M005
QualiLife persimmon foot and shoeUNDECYLENIC ACIDGuangdong Aimu Biological Technology Co., Ltd584966c7-ceae-91af-e063-6294a90ac1eb2026-08-10WarningsExact identifier
application number: M005
Persiancat ANTIFUNGAL PENUNDECYLENIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.58affb96-6cfc-b1fb-e063-6294a90a340c2026-08-10WarningsExact identifier
application number: M005
Dryello Tolnaftate 1% AntifungalTOLNAFTATEProPedix, Inc.58b6820c-f601-5921-e063-6294a90aa5e92026-08-10WarningsExact identifier
application number: M005
MedlineMICONAZOLE NITRATEMedline Industries, LP3c43ef91-bbd2-5e58-e063-6294a90a00d32026-08-05WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEFamily Dollar Services, Inc57c20748-fdad-b73b-e063-6294a90a1c172026-08-04WarningsExact identifier
application number: M005
Lyssera Fungal Nail RenewalUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.5843c1a0-ab60-bd64-e063-6294a90af8582026-08-04WarningsExact identifier
application number: M005
YAMANGU FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.5843cc12-de66-ca47-e063-6294a90ae55b2026-08-04WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEAmerisourceBergen Drug Corporation58dffd8e-49ef-e03e-e063-6394a90abf5d2026-08-04WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSNb564f971-2a9b-a605-e053-2995a90aee693
998483miconazole nitrate 20 MG/ML Topical CreamSCDb564f971-2a9b-a605-e053-2995a90aee693
998483miconazole nitrate 2 % Topical CreamSYb564f971-2a9b-a605-e053-2995a90aee693
998483miconazole nitrate 2 % Topical CreamPSNc6098653-351a-449f-9b1a-0c617074f2b92
998483miconazole nitrate 20 MG/ML Topical CreamSCDc6098653-351a-449f-9b1a-0c617074f2b92
998483miconazole nitrate 2 % Topical CreamSYc6098653-351a-449f-9b1a-0c617074f2b92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-481-45680010481451 TUBE in 1 CARTON (68001-481-45) / 28.4 g in 1 TUBE1 tube2020-12-010000-00-00NoNoCurrent
68001-481-47680010481471 TUBE in 1 CARTON (68001-481-47) / 42.5 g in 1 TUBE1 tube2020-12-010000-00-00NoNoCurrent
68001-481-48680010481481 TUBE in 1 CARTON (68001-481-48) / 14.2 g in 1 TUBE1 tube2020-12-010000-00-00NoNoCurrent