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 7 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EZBIORT 1% Tolnaftate Nail Essence with Biotin	TOLNAFTATE	Guangzhou Borderless Technology Co., Ltd.	5629df38-1079-be4f-e063-6394a90a1c6a	2026-07-09	Warnings	Exact identifier application number: M005
ZENJBUST Undecylenic Acid 25% Antifungal Pen	UNDECYLENIC ACID 25% ANTIFUNGAL PEN	Shenzhen Xituo Electronics Co., Ltd	563a6704-f662-3f08-e063-6394a90a4369	2026-07-09	Warnings	Exact identifier application number: M005
Antifungal Cream	ANTIFUNGAL	Preferred Pharmaceuticals Inc.	c6098653-351a-449f-9b1a-0c617074f2b9	2026-07-08	Warnings	Exact identifier application number: M005
YEARCHOICE Fungal Nail Renewal	FUNGAL NAIL RENEWAL	Guangzhou Jingliang Cosmetics Co., Ltd.	561b650d-028c-687c-e063-6394a90a166a	2026-07-08	Warnings	Exact identifier application number: M005
CAREALL Clotrimazole	CLOTRIMAZOLE	New World Imports, Inc	561d3e64-ab9c-1074-e063-6394a90a1298	2026-07-08	Warnings	Exact identifier application number: M005
Beautifier Life ALCOHOL WIPES	BEAUTIFIER LIFE ALCOHOL WIPES	Shenzhen Shierjie Biological Engineering Co., LTD	323ef469-e37c-00ad-e063-6394a90ab6f7	2026-07-08	Warnings	Exact identifier application number: M005
Folliculitis Treatment Cream	MICONAZOLE NITRATE 2%	Guangxi Keyun E-commerce Co., Ltd.	5625652a-193d-0318-e063-6294a90a56f3	2026-07-08	Warnings	Exact identifier application number: M005
PureWellness FUNGAL FUSION Antifungal and Antimicrobial Kit	FUNGAL FUSION ANTIFUNGAL AND ANTIMICROBIAL KIT	PureWellness LLC	25db8c55-0fa9-4795-8e05-4d3a7aaf0148	2026-07-06	Warnings	Exact identifier application number: M005
FUNGAL NAIL NIGHTTIME RENEWAL PATCHES	TOLNAFTATE 1%	100 KARMA INC	3b9ab6e0-8773-f909-e063-6394a90ac1c9	2026-07-03	Warnings	Exact identifier application number: M005
TOENAIL FUNGUS TREATMENT	25% UNDECYLENIC ACID	100 KARMA INC	3bb000dc-5e6c-b43b-e063-6394a90a63a9	2026-07-03	Warnings	Exact identifier application number: M005
Treatonic Toenail Fungus Treatment Kit	TOENAIL FUNGUS TREATMENT	100 KARMA INC	3d4bbc65-955f-8fd8-e063-6294a90adc44	2026-07-03	Warnings	Exact identifier application number: M005
Treatonic Nailtonic Repair Pens	25% UNDECYLENIC ACID	100 KARMA INC	4a9c32b3-e78d-3c85-e063-6394a90a7bf2	2026-07-03	Warnings	Exact identifier application number: M005
Initial Treatonic FUNGAL NAIL RENEWAL PATCHES	TOLNAFTATE 1%	100 KARMA INC	48e377b4-abb1-34cf-e063-6294a90a2ea3	2026-07-03	Warnings	Exact identifier application number: M005
Treatonic TONENAIL FUNGUS TREATONIC kit.	25% UNDECYLENIC ACID AND TOLNAFTATE 1%	100 KARMA INC	4c197131-9ca8-6024-e063-6294a90aa9cb	2026-07-03	Warnings	Exact identifier application number: M005
Treatonic Antifungal Pen	25% UNDECYLENIC ACID	100 KARMA INC	52d89172-e8a7-70c0-e063-6294a90a3563	2026-07-03	Warnings	Exact identifier application number: M005
FUNGINIX ANTI-FUNGAL TREATMENT	UNDECYLENIC ACID	The Sisquoc Healthcare Corporation	92db5433-5a1b-4cb9-b8eb-217c2a807a99	2026-07-02	Warnings	Exact identifier application number: M005
Anti Dandruff	KETOCONAZOLE	Guangzhou ChuanMa International Trading Co.,Ltd.	4cfe234c-49c0-18e8-e063-6294a90a0b1d	2026-07-02	Warnings	Exact identifier application number: M005
Terpenicol Antifungal Cream	MICONAZOLE NITRATE	Blaine Labs Inc.	9a4ec493-0b36-4bb8-aa9a-55cf5f79aeaa	2026-07-01	Warnings	Exact identifier application number: M005
BeamBalm ANTIFUNGAL FOOT SOAKING PACK	ZINC UNDECYLENATE 5% ANTIFUNGAL FOOT SOAKING PACK	Jiangxi Yudexi Pharmaceutical Co., LTD	50044b55-8553-ca52-e063-6394a90a0e54	2026-07-01	Warnings	Exact identifier application number: M005
VENROCK	UNDECYLENIC ACID	Guangzhou Oupeng Cosmetics Co., Ltd.	558af06e-6fe1-c926-e063-6394a90a738c	2026-07-01	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