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 13 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medi-First Clotrimazole 1% ANTIFUNGAL Cream	CLOTRIMAZOLE	Unifirst First Aid Corporation	522eeb91-8378-32f4-e063-6394a90aff43	2026-05-20	Warnings	Exact identifier application number: M005
Kopa Haiku Antifungal Cream	MICONAZOLE NITRATE 2%	Trovina Co. Ltd	47cf1251-5965-045a-e063-6394a90ab04f	2026-05-19	Warnings	Exact identifier application number: M005
APUREE PRO Nailtific Maximum Strength Antifungal Patches	APUREE PRO NAILTIFIC MAXIMUM STRENGTH ANTIFUNGAL PATCHES	Guangzhou Meixi Biotechnology Co., Ltd.	5218bd5d-53b4-107f-e063-6394a90ae769	2026-05-18		Exact identifier application number: M005
APUREE Pro Nailtific Maximum Strength Dual-Action Antifungal Pen	APUREE PRO NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PEN	Guangzhou Meixi Biotechnology Co., Ltd.	521a0e40-a218-fabb-e063-6294a90ae9a2	2026-05-18	Warnings	Exact identifier application number: M005
Beukow Antifungal Pen	UNDECYLENIC ACID 25% ANTIFUNGAL PEN	Jiangxi Yudexi Pharmaceutical Co., LTD	511d1edf-dfda-477c-e063-6294a90aa423	2026-05-17	Warnings	Exact identifier application number: M005
Nail Repair Pen	NAIL REPAIR PEN	Shenzhen Earth Surface Trading Co., Ltd.	520f6514-6660-d6a8-e063-6394a90adf82	2026-05-17	Warnings	Exact identifier application number: M005
Fungicure Intensive	CLOTRIMAZOLE	Kobayashi Healthcare International, Inc.	1f1b413f-278e-434f-8590-4cf731663f5c	2026-05-15	Warnings	Exact identifier application number: M005
Dr Scholls Fungal Nail Clear and Cure Tolnaftate Antifungal	TOLNAFTATE	Scholl's Wellness Company LLC	8abd6d8e-c69e-4374-ace8-d42b2d3e171e	2026-05-14	Warnings	Exact identifier application number: M005
Dr.Scholl s Odor X Athlete s Foot	TOLNAFTATE	Scholl's Wellness Company LLC	0e864882-5e00-491e-a008-0762c131637a	2026-05-14	Warnings	Exact identifier application number: M005
Athletes Foot	TOLNAFTATE	Rugby Laboratories	50c46cf5-3e64-9e0f-e063-6294a90a2317	2026-05-14	Warnings	Exact identifier application number: M005
TOSSOYA Rainforest SecretGuard Antibacterial Quick-Cleanse Wipes	TOSSOYA RAINFOREST SECRETGUARD ANTIBACTERIAL QUICK-CLEANSE WIPES	Shenzhen Shierjie Biological Engineering Co., LTD	3d53463d-8d8e-9030-e063-6294a90ab454	2026-05-13	Warnings	Exact identifier application number: M005
Anti-Fungal Powder	MICONAZOLE NITRATE	CVS Pharmacy	1651bdd7-ab15-7a2d-e063-6294a90a8b91	2026-05-11	Warnings	Exact identifier application number: M005
Lightning X Hand Cleanser	ETHYL ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	51861f1e-8961-e876-e063-6394a90a2fd0	2026-05-11	Warnings	Exact identifier application number: M005
APUREE Nailtific Maximum Strength Antifungal Patches PRO	APUREE NAILTIFIC MAXIMUM STRENGTH ANTIFUNGAL PATCHES PRO	Guangzhou Meixi Biotechnology Co., Ltd	5189ebc5-8ee5-1b2c-e063-6294a90af5c8	2026-05-11	Warnings	Exact identifier application number: M005
APUREE Nailtific Maximum Strength Dual-Action Antifungal Pen Pro	APUREE NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PEN PRO	Guangzhou Meixi Biotechnology Co., Ltd.	518abf2b-6ac8-ab9b-e063-6294a90ae693	2026-05-11	Warnings	Exact identifier application number: M005
CLOTRIMAZOLE	CLOTRIMAZOLE	Rugby Laboratories, Inc.	2c60e631-5930-4420-886d-eb1990c720b6	2026-05-11	Warnings	Exact identifier application number: M005
Tolfyra	TOLNAFTATE	Oncora Pharma, LLC	b28ee9f2-fc45-4336-b374-be7aa51d44e9	2026-05-11	Warnings	Exact identifier application number: M005
clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	c0f58a0d-a304-41f9-bbdf-c2e488230cf0	2026-05-11	Warnings	Exact identifier application number: M005
Inlifay ANTIFUNGAL	TOLNAFTATE	Guangdong Aimu Biological Technology Co., Ltd	5148b838-d26e-cf66-e063-6394a90ae469	2026-05-09	Warnings	Exact identifier application number: M005
HuiPoLii NAIL PFLASTER	TOLNAFTATE 1% NAIL PFLASTER	Jiangxi Yudexi Pharmaceutical Co., LTD	514b1c2d-cecb-30a2-e063-6394a90af266	2026-05-08	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