FDA.reportPublic FDA data

Baza Antifungal

Product NDC
11701-045
Requested package NDC
11701-045-22
11-digit product format
117010045
Labeler code
11701
Product ID
11701-045_1b6f34e8-44ed-435a-9741-fc4d859b541f
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Coloplast Corp
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-06-15
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Additional Listing Data#

Finished product
Yes
Brand name base
Baza Antifungal
Listing expiration
2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998483Internal RxNorm lookup
998493Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
75182cb7-840a-423a-9c20-10840d6e1d65Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
11701-045-142024-12-26Baza ® Antifungal Antifungal Moisture Barrier Antifungal Cream
11701-045-222024-12-26Baza ® Antifungal Antifungal Moisture Barrier Antifungal Cream
11701-045-232024-12-26Baza ® Antifungal Antifungal Moisture Barrier Antifungal Cream
11701-045-142023-01-30Baza ® Antifungal Antifungal Moisture Barrier Antifungal Cream
11701-045-222023-01-30Baza ® Antifungal Antifungal Moisture Barrier Antifungal Cream
11701-045-232023-01-30Baza ® Antifungal Antifungal Moisture Barrier Antifungal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11701-045-14Baza Antifungal142 g in 1 TUBECREAM14210
11701-045-22Baza Antifungal4 g in 1 PACKETCREAM410
11701-045-23Baza Antifungal57 g in 1 TUBECREAM5710

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11701-045-14GM - Gram11701-045387f5d9c-bbfa-4572-ada8-b8a1a27de39e12012-07-24
11701-045-22GM - Gram11701-04587ac6440-1bb9-4939-a96d-a0ca5057468312012-07-24
11701-045-23GM - Gram11701-045d3131d7f-0c66-4363-b855-b69f1a2f6caa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
MICONAZOLEACTIVE MOIETY7NNO0D7S5MBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
CETEARETH-6INACTIVE INGREDIENT2RJS3559D3BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
COD LIVER OILINACTIVE INGREDIENTBBL281NWFGBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
LANOLININACTIVE INGREDIENT7EV65EAW6HBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZBAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11701-045BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]7Current NDC, Legacy NDC, 3 package rows20241228_75182cb7-840a-423a-9c20-10840d6e1d65.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 1 of 52 · 1,021 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Defense Antifungal Medicated BarTOLNAFTATEDefense Soap LLC812d78ea-a14a-e3a2-e053-2a91aa0a6ff52026-09-09WarningsExact identifier
application number: M005
Radthary GROIN ANTIFUNGAL CreamMICONAZOLE NITRATE 2% GROIN ANTIFUNGAL CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5b1945f3-84ba-f3dc-e063-6294a90ab8a02026-09-09WarningsExact identifier
application number: M005
MedlineMICONAZOLE NITRATEMedline Industries, LP0d997d1d-8663-201f-e063-6394a90a285e2026-09-08WarningsExact identifier
application number: M005
Remedy Antifungal With OlivamineMICONAZOLE NITRATEMedline Industries, LP28c5183e-05b4-1754-e054-00144ff8d46c2026-09-08WarningsExact identifier
application number: M005
ClaravieMICONAZOLE NITRATE 2%Gentell LLC5afdc429-cb44-703c-e063-6294a90a971a2026-09-08WarningsExact identifier
application number: M005
HSENJT Antifungal CreamMICONAZOLE NITRATEHuizhou Haosen Trading Co., Ltd.5aa587f5-5ddf-542a-e063-6294a90a522b2026-09-07WarningsExact identifier
application number: M005
Inlifay ANTIFUNGALMICONAZOLE NITRATE 2% ANTIFUNGALJiangxi Yudexi Pharmaceutical Co., LTD4a832f39-ac11-d8b3-e063-6394a90acb392026-09-06WarningsExact identifier
application number: M005
Noicaky FUNGAL NAIL PatchesTOLNAFTATE 1% FUNGAL NAIL PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.5adcc5f7-2d47-2ad7-e063-6294a90a48482026-09-06WarningsExact identifier
application number: M005
LIFE66II ANTIFUNGAL NAILUNDECYLENIC ACID 25% ANTIFUNGAL NAILWenzhou Yuyuan Pharmaceutical Co., Ltd.5ab83796-0780-3b58-e063-6394a90a2e4e2026-09-05WarningsExact identifier
application number: M005
FGPER Topical Antifungal PenUNDECYLENIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.5abdcbff-6ab1-2f0a-e063-6294a90a57ef2026-09-05WarningsExact identifier
application number: M005
AOUGK SALICYLIC ACID WART REMOVERSALICYLIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.5ac88b51-b46c-5cc6-e063-6394a90af9e52026-09-05WarningsExact identifier
application number: M005
Jock Itch PowderMICONAZOLE NITRATEPremier Brands of America Inc5aaacc88-6752-ab47-e063-6394a90af7cd2026-09-04WarningsExact identifier
application number: M005
ANTIFUNGAL BODY WASHTOLNAFTATEGuangzhou ChuanMa International Trading Co.,Ltd.5a695043-f776-df5a-e063-6394a90ac2742026-09-01WarningsExact identifier
application number: M005
KetoconClear CreamKETOCONAZOLEGuangzhou Shunfei Network Technology Co., Ltd.5a54eebe-5b4a-28dd-e063-6294a90a607f2026-08-31WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEInvaDerm Corporation5a5cfed9-0587-7bef-e063-6294a90a64bf2026-08-31WarningsExact identifier
application number: M005
Gembooxt RINGWORM CreamMICONAZOLE NITRATE, HYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.464a33c3-6d16-0cfd-e063-6294a90abf4b2026-08-27WarningsExact identifier
application number: M005
DrAny NAIL FUNGUS TREATMENTUNDECYLENIC ACID, TOLNAFTATEHong Kong Juxin Negosyo Kag Komersyo Co., Limited59ef412b-fc7b-0a84-e063-6394a90abf252026-08-26WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATESun Pharmaceutical Industries, Inc.7fd4037e-d350-47b7-a7d9-a43b8e366fa02026-08-25WarningsExact identifier
application number: M005
WISH HAND SANITIZER pink dragon blossomALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593b3fbe-a8de-1c09-e063-6294a90adc692026-08-24WarningsExact identifier
application number: M005
Okkazhie WART REMOVER40% SALICYLIC ACIDGuangzhou Huixue Biotechnology Co., Ltd.59c2d759-d1e9-6c9d-e063-6294a90a04db2026-08-23WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998493Baza Antifungal 2 % Topical CreamPSN75182cb7-840a-423a-9c20-10840d6e1d6510
998483miconazole nitrate 2 % Topical CreamPSN75182cb7-840a-423a-9c20-10840d6e1d6510
998493miconazole nitrate 20 MG/ML Topical Cream [Baza]SBD75182cb7-840a-423a-9c20-10840d6e1d6510
998483miconazole nitrate 20 MG/ML Topical CreamSCD75182cb7-840a-423a-9c20-10840d6e1d6510
998493BAZA 20 MG/ML Topical CreamSY75182cb7-840a-423a-9c20-10840d6e1d6510
998493Baza Antifungal 2 % Topical CreamSY75182cb7-840a-423a-9c20-10840d6e1d6510
998483miconazole nitrate 2 % Topical CreamSY75182cb7-840a-423a-9c20-10840d6e1d6510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11701-045-22117010045224 g in 1 PACKET (11701-045-22) 4 g2009-06-150000-00-00NoNoCurrent