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 42 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tolnaftate	TOLNAFTATE	Sheffield Pharmaceuticals LLC	ca52af37-c3a2-414c-a24a-a37a92925133	2025-02-20	Warnings	Exact identifier application number: M005
Dr Sheffield Athletes Foot	CLOTRIMAZOLE	Sheffield Pharmaceuticals LLC	b8b8e6b2-1022-4592-91ba-3cf94c7cf318	2025-02-19	Warnings	Exact identifier application number: M005
UKVOA Toenail Fungus Treatment	TOLNAFTATE 1% FUNGI NAIL	Jiashen International Trade Limited	2e3cde7b-850e-f9d2-e063-6394a90adb18	2025-02-16	Warnings	Exact identifier application number: M005
UKOVA FOOT ODOR PROBIOTIC	TOLNAFTATE 1% FUNGI NAIL	Jiashen International Trade Limited	2de0225d-dd85-e2da-e063-6294a90a050b	2025-02-11	Warnings	Exact identifier application number: M005
Dr. Scholls Instant Cool Athletes Foot Wipes	TOLNAFTATE	Cosco International, Inc.	cde656a9-7841-4a73-a2f4-f5a76a3e15c1	2025-02-06	Warnings	Exact identifier application number: M005
Silka Athletes Foot	MICONAZOLE NITRATE	Genomma Lab USA	307104a2-2df6-43b0-bf3f-f4d93d3e40f1	2025-02-05	Warnings	Exact identifier application number: M005
MICONAZOLE Nitrate	MICONAZOLE NITRATE	NuCare Pharmaceuticals,Inc.	fd7dd2eb-03a7-ef1f-e053-6294a90a8557	2025-02-04	Warnings	Exact identifier application number: M005
Molecular AF	TOLNAFTATE	Renu Laboratories, LLC	1b47e687-29cf-48ce-8bc3-ac8f44f05baa	2025-02-03	Warnings	Exact identifier application number: M005
Dermatool Fungal Nail Treatment	TOLNAFTATE 1%	Papalo Group LLC	2d2c0e12-123d-75bd-e063-6394a90ae546	2025-01-31	Warnings	Exact identifier application number: M005
70% Isopropyl Alcohol	ISOPROPYL ALCOHOL	IDO PHARM	d5833c6f-81dd-6ff6-e053-2995a90ac76d	2025-01-30	Warnings	Exact identifier application number: M005
AWAS ALCOHOLSPRAY	ALCOHOL	IDO PHARM	03010837-0289-3e08-e063-6394a90a7d04	2025-01-30	Warnings	Exact identifier application number: M005
ELON Dual Defense Anti Fungal Formula	UNDECYLENIC ACID	Little Giant Holdings LLC	45c4567d-7876-6459-e054-00144ff88e88	2025-01-28	Warnings	Exact identifier application number: M005
DCH Labs Antifungal Jock	MICONAZOLE NITRATE 2%	Derma Care Research Labs, LLC	fc749882-2e1e-cad3-e053-6294a90a33ca	2025-01-27	Warnings	Exact identifier application number: M005
Antifungal Pen	UNDECYLENIC ACID 25%	XF Agencija Limited	a15d4512-0fc6-424f-9dd3-ab433d9b7a26	2025-01-27	Warnings	Exact identifier application number: M005
Mata Hongos	UNDECYLENIC ACID	Vitamex USA, Corp	21ca7edb-dde3-5846-e063-6394a90a3cc0	2025-01-23	Warnings	Exact identifier application number: M005
Povidone Iodine Scrub	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	53cb4c0d-40b5-4cf3-b122-fd6dd654883f	2025-01-23	Warnings	Exact identifier application number: M005
NATUREPLEX TOLNAFTATE ANTIFUNGAL	TOLNAFTATE	Natureplex, LLC	575b8645-9166-4242-a74f-f4aa4acaaf3d	2025-01-15	Warnings	Exact identifier application number: M005
Tobcharm Antifungal Treatment Cream	ANTIFUNGAL TREATMENT CREAM	Guangzhou Zanming Trading Co., Ltd.	2ba241cc-2767-1190-e063-6294a90ac66b	2025-01-13	Warnings	Exact identifier application number: M005
MICONAZOLE Nitrate 2%	MICONAZOLE NITRATE	Akron Pharma Inc.	8933f939-098a-4257-8d9c-4d5c3240e9a6	2025-01-10	Warnings	Exact identifier application number: M005
ANTI-ITCH FEMININE CARE	HYDROCORTISONE 0.5%	OL PHARMA TECH, LLC Drs PHARMACY	d6fa5ff3-ebdc-222d-e053-2a95a90a88d5	2025-01-09	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