Baza Antifungal

Product NDC: 11701-045
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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11701-045-23	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11701-045-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11701-045-22	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	11701-045-23	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	11701-045-14	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	11701-045-22	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	11701-045-23	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	11701-045-14	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	11701-045-22	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	11701-045-23	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	11701-045-14	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	11701-045-22	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	11701-045-23	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	11701-045-14	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	11701-045-22	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	11701-045-23	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	11701-045-14	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	11701-045-22	`1332a3947898…`	`d4bfe170f9cd…`

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: Baza Antifungal
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MICONAZOLE NITRATE	20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VW4H1CYW1K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
75182cb7-840a-423a-9c20-10840d6e1d65	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866a	Product name	1	20140508
5b9a7965-36d2-8412-dcaf-f76a65411611	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
11701-045-14	2024-12-26	Baza ® Antifungal Antifungal Moisture Barrier Antifungal Cream
11701-045-22	2024-12-26	Baza ® Antifungal Antifungal Moisture Barrier Antifungal Cream
11701-045-23	2024-12-26	Baza ® Antifungal Antifungal Moisture Barrier Antifungal Cream
11701-045-14	2023-01-30	Baza ® Antifungal Antifungal Moisture Barrier Antifungal Cream
11701-045-22	2023-01-30	Baza ® Antifungal Antifungal Moisture Barrier Antifungal Cream
11701-045-23	2023-01-30	Baza ® Antifungal Antifungal Moisture Barrier Antifungal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11701-045-14	Baza Antifungal	142 g in 1 TUBE	CREAM	142	10
11701-045-22	Baza Antifungal	4 g in 1 PACKET	CREAM	4	10
11701-045-23	Baza Antifungal	57 g in 1 TUBE	CREAM	57	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11701-045-14	GM - Gram	11701-045	387f5d9c-bbfa-4572-ada8-b8a1a27de39e	1	2012-07-24
11701-045-22	GM - Gram	11701-045	87ac6440-1bb9-4939-a96d-a0ca50574683	1	2012-07-24
11701-045-23	GM - Gram	11701-045	d3131d7f-0c66-4363-b855-b69f1a2f6caa	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MICONAZOLE NITRATE	ACTIVE INGREDIENT	VW4H1CYW1K	BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
MICONAZOLE	ACTIVE MOIETY	7NNO0D7S5M	BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
CETEARETH-6	INACTIVE INGREDIENT	2RJS3559D3	BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
COD LIVER OIL	INACTIVE INGREDIENT	BBL281NWFG	BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
ZINC OXIDE	INACTIVE INGREDIENT	SOI2LOH54Z	BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11701-045	BAZA ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COLOPLAST MANUFACTURING US, LLC]	7	Current NDC, Legacy NDC, 3 package rows	20241228_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 16 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EXTRA STRENGTH TOENAIIL RENEWAL PEN	UNDECYLENIC ACID, TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	4eea5ee7-0ef9-8d34-e063-6294a90af595	2026-04-07	Warnings	Exact identifier application number: M005
EXTRA STRENGTH TOENAIIL RENEWAL Solution	UNDECYLENIC ACID, TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	4eeaa2f0-efc7-eab3-e063-6294a90a13b3	2026-04-07	Warnings	Exact identifier application number: M005
Extra Strength Toenail Renewal Pen	UNDECYLENIC ACID, TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	4eeb59d2-3891-2e45-e063-6294a90a4fcf	2026-04-07	Warnings	Exact identifier application number: M005
RoyceDerm Tinea ANTIFUNGAL .soap.	CLOTRIMAZOLE 1%	RoyceDerm LLC	4e889f2b-9ea1-b1a6-e063-6394a90a4654	2026-04-03	Warnings	Exact identifier application number: M005
Toenail Fungus Treatment Extra Strength Pen	TOLNAFTATE, UNDECYLENIC ACID	Lianjiang Shanlilai E-commerce Co., Ltd.	28fbcc50-a3ac-d6d1-e063-6294a90aa2b6	2026-04-02	Warnings	Exact identifier application number: M005
TOENAIL FUNGUS TREATMENT Liquid	TOLNAFTATE, UNDECYLENIC ACID	Lianjiang Shanlilai E-commerce Co., Ltd.	28fc7049-e367-42bf-e063-6394a90a6f06	2026-04-02	Warnings	Exact identifier application number: M005
Fungal Nail Patches	TOLNAFTATE, UNDECYLENIC ACID	Lianjiang Shanlilai E-commerce Co., Ltd.	299a63ad-f321-117c-e063-6394a90a3a22	2026-04-02	Warnings	Exact identifier application number: M005
Secura Antifungal Greaseless	MICONAZOLE NITRATE	Smith & Nephew Medical Ltd	9be600e4-76ec-4071-a8ec-a0b23155271d	2026-04-02	Warnings	Exact identifier application number: M005
FifthPulse Bacitracin Zinc	BACITRACIN ZINC	WeCare Products LLC	5c6b3ad8-c158-4cc0-b1ba-b829b5df1284	2026-04-02	Warnings	Exact identifier application number: M005
FifthPulse Miconazole Nitrate Antifungal	MICONAZOLE NITRATE	WeCare Products LLC	b70238eb-afcb-4e09-976f-973df249241c	2026-04-02	Warnings	Exact identifier application number: M005
ANTIFUNGAL PEN	UNDECYLENIC ACID, TERBINAFINE HYDROCHLORIDE	Hanyang Qisheng (Shenzhen) Technology Co., Ltd.	4e85f338-ffd7-85b1-e063-6294a90a3c87	2026-04-02	Warnings	Exact identifier application number: M005
RoyceDerm Anti-Fungal Cream	MICONAZOLE NITRATE 2%	RoyceDerm LLC	4e861073-88e8-b2f7-e063-6394a90ab94a	2026-04-02	Warnings	Exact identifier application number: M005
Miconazole Nitrate	JOCK ITCH SPRAY	CVS Pharmacy	7b70d3ea-126a-42aa-8509-b982893c710b	2026-04-01	Warnings	Exact identifier application number: M005
Fungicure Anti-Fungal Liquid	TOLNAFTATE	Kobayashi Healthcare International, Inc.	b18ee199-0659-733c-e053-2a95a90ab6b5	2026-04-01	Warnings	Exact identifier application number: M005
Tolnaftate	ANTIFUNGAL LIQUID SPRAY	CVS Pharmacy	96cc594d-85c8-4f62-bc0a-3176c8739f21	2026-04-01	Warnings	Exact identifier application number: M005
Tolnafate	TOLNAFTATE POWDER SPRAY	CVS Pharmacy	a7b6bd7c-23db-43e1-92f7-e27f5f4801de	2026-04-01	Warnings	Exact identifier application number: M005
Baza Antifungal	MICONAZOLE NITRATE	Coloplast Corp	75182cb7-840a-423a-9c20-10840d6e1d65	2026-03-31	Warnings	Exact identifier application number: M005 ndc (product): 11701-045
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	Trifecta Pharmaceuticals Usa Llc	80217dbb-a0f0-414a-8d22-a9a346b017aa	2026-03-31	Warnings	Exact identifier application number: M005
RoyceDerm Antifungal Bar	CLOTRIMAZOLE	RoyceDerm LLC	3abdc4a8-58dd-5bd0-e063-6294a90a1bca	2026-03-31	Warnings	Exact identifier application number: M005
Critic Aid Clear AF	MICONAZOLE NITRATE	Coloplast Corp	cbc5d976-850a-476e-b179-b7a5a8675524	2026-03-31	Warnings	Exact identifier application number: M005

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VW4H1CYW1K	MICONAZOLE NITRATE	22832-87-7	MICONAZOLE NITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
998493	Baza Antifungal 2 % Topical Cream	PSN	75182cb7-840a-423a-9c20-10840d6e1d65	10
998483	miconazole nitrate 2 % Topical Cream	PSN	75182cb7-840a-423a-9c20-10840d6e1d65	10
998493	miconazole nitrate 20 MG/ML Topical Cream [Baza]	SBD	75182cb7-840a-423a-9c20-10840d6e1d65	10
998483	miconazole nitrate 20 MG/ML Topical Cream	SCD	75182cb7-840a-423a-9c20-10840d6e1d65	10
998493	BAZA 20 MG/ML Topical Cream	SY	75182cb7-840a-423a-9c20-10840d6e1d65	10
998493	Baza Antifungal 2 % Topical Cream	SY	75182cb7-840a-423a-9c20-10840d6e1d65	10
998483	miconazole nitrate 2 % Topical Cream	SY	75182cb7-840a-423a-9c20-10840d6e1d65	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11701-045-14	11701004514	142 g in 1 TUBE (11701-045-14)	142 g	2009-06-15	0000-00-00	No	No	Current
11701-045-22	11701004522	4 g in 1 PACKET (11701-045-22)	4 g	2009-06-15	0000-00-00	No	No	Current
11701-045-23	11701004523	57 g in 1 TUBE (11701-045-23)	57 g	2009-06-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Baza ® Antifungal Antifungal Moisture Barrier Antifungal Cream	Coloplast Corp \| Coloplast Corp. \| Medline Industries, LP	2026-03-31	HUMAN OTC DRUG LABEL	10