VAGISTEN-V

Product NDC: 69729-612
11-digit product format: 697290612
Labeler code: 69729
Product ID: 69729-612_214e6edc-8028-e8d5-e063-6394a90af7a0
Type: HUMAN OTC DRUG
Nonproprietary name: MICONAZOLE NITRATE
Dosage form: CREAM
Route: VAGINAL
Labeler: OPMX LLC
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-09-05
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

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	69729-612-05	`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	69729-612-05	`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	69729-612-05	`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	69729-612-05	`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	69729-612-05	`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	69729-612-05	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69729-612-05	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69729-612-05	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69729-612-05	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69729-612-05	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69729-612-05	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	69729-612-05	`9bebd1f3094a…`	`5416666fcb17…`

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: VAGISTEN-V
Brand name suffix: 7 DAY
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MICONAZOLE NITRATE	2 g/100g

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
998540	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
a5bfa501-5ae1-4434-bc31-995d0665b99e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69729-612-05	2024-11-29	C162847	48780-1	9d75b9d0-0c4c-f424-e053-dadaa90a57ce	OPMX (as PLD) - Vagisten-V (69729-612)
69729-612-05	2020-01-31	C162847	48780-1	9d75b9d0-0c4c-f424-e053-dadaa90a57ce	OPMX (as PLD) - Vagisten-V (69729-612)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69729-612-01	VAGISTEN-V7 DAY	14 g in 1 TUBE	CREAM	14		2
69729-612-05	VAGISTEN-V7 DAY	1 in 1 BOX	CREAM	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69729-612	VAGISTEN-V 7 DAY (MICONAZOLE NITRATE) CREAM [OPMX LLC]	2	Current NDC, Legacy NDC, 2 package rows	20241201_a5bfa501-5ae1-4434-bc31-995d0665b99e.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 26 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bee Venom Toenail Fungus Treatment	BEE VENOM TOENAIL FUNGUS TREATMENT	Shenzhen Earth Surface Trading Co., Ltd.	457c705a-9c49-c8c5-e063-6394a90a6aa3	2025-12-08	Warnings	Exact identifier application number: M005
Tolnaftate Antifungal Powder	TOLNAFTATE	SCHOLL'S WELLNESS COMPANY LLC	2a0e006b-60b1-41b9-a5d2-ff0e34b48ff5	2025-12-06	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	1e7e74f6-9bca-48ab-804a-a7a81df3b608	2025-12-05	Warnings	Exact identifier application number: M005
Oiangna Tea Tree Oil Antifungal	CLOTRIMAZOLE 1%	Guangzhou Huixue Biotechnology Co., Ltd.	453452a7-c613-6111-e063-6294a90aca81	2025-12-05	Warnings	Exact identifier application number: M005
Tinactin Antifungal	TOLNAFTATE	Bayer HealthCare LLC.	5f95be36-6efa-4dfb-9a40-88f4ce1de2b3	2025-12-05	Warnings	Exact identifier application number: M005
Tinactin	TOLNAFTATE	Bayer HealthCare LLC.	c3b715a9-233a-401a-ba60-f78c1ddf1ded	2025-12-05	Warnings	Exact identifier application number: M005
Lotrimin	CLOTRIMAZOLE	Bayer HealthCare LLC.	b584e17f-ed43-43bd-b643-dfa48edd78c6	2025-12-05	Warnings	Exact identifier application number: M005
Fungicure Night Cream	CLOTRIMAZOLE	Kobayashi Healthcare International, Inc.	43029403-2afd-cfa1-e063-6394a90a99a3	2025-12-04	Warnings	Exact identifier application number: M005
Lotrimin Daily Prevention Deo	TOLNAFTATE	Bayer HealthCare LLC.	9e8bfb78-ad81-93d0-e053-2995a90aa41d	2025-12-04	Warnings	Exact identifier application number: M005
Lotrimin AF Jock Itch	MICONAZOLE NITRATE	Bayer Healthcare LLC.	0c53cf0f-767e-a422-e063-6394a90ab764	2025-12-04	Warnings	Exact identifier application number: M005
Tinactin	TOLNAFTATE	Bayer HealthCare LLC.	0a80a5b0-3216-46f6-8801-7066ef59aee4	2025-12-04	Warnings	Exact identifier application number: M005
Lotrimin Antifungal	CLOTRIMAZOLE	Bayer HealthCare LLC.	f9536683-3f32-4c71-9b6a-70f8611e3dcf	2025-12-04	Warnings	Exact identifier application number: M005
Lotrimin AF Deodorant	MICONAZOLE NITRATE	Bayer HealthCare LLC.	0bee54eb-df2f-15fe-e063-6294a90a2fd2	2025-12-04	Warnings	Exact identifier application number: M005
Tinactin	TOLNAFTATE	Bayer HealthCare LLC.	0beda157-efd2-5245-e063-6394a90a6911	2025-12-04	Warnings	Exact identifier application number: M005
Lotrimin AF	MICONAZOLE NITRATE	Bayer Healthcare LLC.	163996c6-af54-21ac-e063-6394a90ac05c	2025-12-04	Warnings	Exact identifier application number: M005
Lotrimin Daily Prevent Deodorant	TOLNAFTATE	Bayer HealthCare LLC.	1bb961cd-b6e6-3aff-e063-6394a90a432e	2025-12-04	Warnings	Exact identifier application number: M005
Tinactin Deodorant	TOLNAFTATE	Bayer HealthCare LLC.	1751d576-e94a-d7d1-e063-6294a90a03ff	2025-12-04	Warnings	Exact identifier application number: M005
Tinactin Jock Itch	TOLNAFTATE	Bayer HealthCare LLC	163ab4df-6e4a-6239-e063-6294a90a1cd0	2025-12-04	Warnings	Exact identifier application number: M005
Tinactin	TOLNAFTATE	Bayer HealthCare LLC	bb878f31-2189-4427-aacf-5bce96d75978	2025-12-04	Warnings	Exact identifier application number: M005
Lotrimin	CLOTRIMAZOLE	Bayer HealthCare LLC	da948ef3-3709-4bfc-9d17-f6f1ea325343	2025-12-04	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
998540	miconazole nitrate 2 % Vaginal Cream	PSN	a5bfa501-5ae1-4434-bc31-995d0665b99e	2
998540	miconazole nitrate 20 MG/ML Vaginal Cream	SCD	a5bfa501-5ae1-4434-bc31-995d0665b99e	2
998540	miconazole nitrate 2 % Vaginal Cream	SY	a5bfa501-5ae1-4434-bc31-995d0665b99e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69729-612-01	69729061201	14 g in 1 TUBE	14 g				Historical
69729-612-05	69729061205	1 TUBE in 1 BOX (69729-612-05) / 14 g in 1 TUBE (69729-612-01)	1 tube	2018-09-05	No	No	Current