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 12 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Athletes Foot	MICONAZOLE NITRATE	Premier Brands of America Inc	52d0909a-f404-0af4-e063-6394a90a3d0c	2026-06-01	Warnings	Exact identifier application number: M005
Kopa Haiku Antifungal Cream	MICONAZOLE NITRATE 2%	Trovina Co. Ltd	431483f6-2386-9f5c-e063-6294a90af104	2026-06-01	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	Walgreens Company	3f8d45e1-54a2-a658-e063-6294a90a6cbb	2026-06-01	Warnings	Exact identifier application number: M005
Remedy Nails	UNDECYLENIC ACID	Adwill Labs Inc	4e87b76c-c430-466a-bc30-fe1785c7c660	2026-06-01	Warnings	Exact identifier application number: M005
Anytalk Nail Fungus Treatment 15ml (1% Tonailate)	TOLNAFTATE1%	Guangzhou Huixue Biotechnology Co., Ltd.	52f1f654-fba3-e90e-e063-6394a90a1df4	2026-05-29	Warnings	Exact identifier application number: M005
RoyceDerm Tea Tree Oil Antifungal .spray.	CLOTRIMAZOLE 1%	RoyceDerm LLC	52da8be4-467c-c011-e063-6294a90a166f	2026-05-28	Warnings	Exact identifier application number: M005
Terramed Just Think Comfort Jock Itch Antifungal Treatment	MICONAZOLE NITRATE	Rida LLC	2acb9027-8f20-4b77-9b45-17fe11622c7c	2026-05-27	Warnings	Exact identifier application number: M005
Quali Life ANTIFUNGAL TEA TREE	TOLNAFTATE	Guangdong Aimu Biological Technology Co., Ltd	52b3b0df-3f62-f9bc-e063-6394a90a52b3	2026-05-26	Warnings	Exact identifier application number: M005
ANTIFUNGAL PEN	UNDECYLENIC ACID	Guangzhou Mizi Biotechnology Co., Ltd.	52b51877-e04c-569e-e063-6394a90a2fc9	2026-05-26	Warnings	Exact identifier application number: M005
NAIL EXTRA STRENGTH REPAIR PEN	UNDECYLENIC ACID	Guangzhou Mizi Biotechnology Co., Ltd.	52b6208d-53e4-eaa0-e063-6394a90abe7a	2026-05-26	Warnings	Exact identifier application number: M005
Toenail Fungus Pen Preventative	UNDECYLENIC ACID	Guangzhou Mizi Biotechnology Co., Ltd.	52b6766f-948b-2602-e063-6294a90a03cf	2026-05-26	Warnings	Exact identifier application number: M005
KDMAN	TOLNAFTATE	Dongguan Youmi Trading Co., Ltd	52a4e836-2059-a49f-e063-6394a90a6556	2026-05-25	Warnings	Exact identifier application number: M005
PUTRIZEN	UNDECYLENIC ACID, TOLNAFTATE	Guangzhou Lianbiquan Biological Technology co., Ltd	52a58f24-2a11-4d34-e063-6394a90a2924	2026-05-25	Warnings	Exact identifier application number: M005
Eye CareSpray	EYELID CLEANSING SPRAY	Shenzhen Shierjie Biological Engineering Co., LTD	52aef5dd-ff33-cace-e063-6294a90a415a	2026-05-25	Warnings	Exact identifier application number: M005
Saviland PRO Extra Strength Toenail Renewal Patches	TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	5250003a-8d3a-818b-e063-6294a90aa659	2026-05-21	Warnings	Exact identifier application number: M005
Saviland SSPro X Series Extra Strength Toenail Renewal Patches	TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	52506297-44d7-b2a7-e063-6394a90a0a3c	2026-05-21	Warnings	Exact identifier application number: M005
SSPROTIP X Extra Strength Nail Renewal Patches	TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	52512e7e-5e28-4383-e063-6294a90a448a	2026-05-21	Warnings	Exact identifier application number: M005
Vrenmol Extra Strength Nail Renewal Patches	TOLNAFTATE	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	52516861-e386-d0cb-e063-6394a90a17d0	2026-05-21	Warnings	Exact identifier application number: M005
SSPROTIP X Extra Strength Toenail Renewal Solution	TOLNAFTATE,UNDECYLENIC ACID	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	52519110-a3c9-21da-e063-6294a90abbce	2026-05-21	Warnings	Exact identifier application number: M005
Fungal Nail Repair Pen	UNDECYLENIC ACID	Yunqi Cosmetics (Shenzhen) Co., Ltd	523c32f7-b803-bf79-e063-6394a90aad5a	2026-05-20	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