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 48 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EVERLIT CARE Hand Sanitizer	ETHYL ALCOHOL	EVERLIT GLOBAL INC.	b9909c59-02e7-4d6c-aa2b-206f1ab4d02c	2023-11-14	Warnings	Exact identifier application number: M005
FLUSH Maximum Strength Antifungal formula	UNDECYLENIC ACID	Triple Point Group, LLC	1d9e56ef-c7c9-4aff-ab9e-b163e566e3d5	2023-11-11	Warnings	Exact identifier application number: M005
SIMPLY VITAL Antifungal Cream	CLOTRIMAZOLE	ALPHA PLANTS INC	d3842de3-0d13-4dc2-920b-90a4b822bbb8	2023-11-11	Warnings	Exact identifier application number: M005
CLARUS AC Antifungal Solution	TOLNAFTATE	Clinical Therapeutic Solutions	28ab9f1b-65cd-4405-a9a3-f3c9b836693d	2023-11-10	Warnings	Exact identifier application number: M005
Signature Black Bottle Tea Tree Antifungal Foot and Body Wash	TOLNAFTATE	Restoration Rockstar, Llc (dba: Kroning Signature Black Bottle)	2c966d97-30f5-4942-b64d-742884ce6a2f	2023-11-10	Warnings	Exact identifier application number: M005
Smooth Gator Fungus Eliminator	CLOTRIMAZOLE	Smooth Gator, LLC	262b04f5-1b5d-4c67-a557-01f8b1711302	2023-11-10	Warnings	Exact identifier application number: M005
TOLNAFTATE ANTIFUNGAL	TOLNAFTATE	Geri-Care Pharmaceuticals, Corp	f9e60430-eec1-4bc2-9522-eb5aa527d90a	2023-11-08	Warnings	Exact identifier application number: M005
Terrasil Jock Itch Treatment Maximum Strength	CLOTRIMAZOLE	Aidance Skincare & Topical Solutions, LLC	c62fbf23-5d19-44ab-9c1a-e9b803192ed0	2023-11-08	Warnings	Exact identifier application number: M005
terrasil The Fungal Solution Kit	CLOTRIMAZOLE	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	9a5eb581-62a2-41fe-a174-e852fc47e235	2023-11-08	Warnings	Exact identifier application number: M005
EmoniNail Antifungal	UNDECYLENIC ACID	GG Healthworks Inc.	84ace47a-d3ae-4735-87b6-dbbf1c40cf54	2023-11-06	Warnings	Exact identifier application number: M005
CIDACIN Antifungal Treatment	TOLNAFTATE	Pedicis Research LLC	bd53a9e3-65c8-4834-8e23-a2a928b83a66	2023-11-05	Warnings	Exact identifier application number: M005
MacerRx Web	MICONAZOLE NITRATE	Clinical Therapeutic Solutions	c9327f41-10f1-41f3-855b-838c701d6767	2023-11-05	Warnings	Exact identifier application number: M005
CLARUS Antifungal	TOLNAFTATE	Clinical Therapeutic Solutions	7e8897ff-67d1-4336-866e-cb76a36edddc	2023-11-05	Warnings	Exact identifier application number: M005
CLARUS Antifungal	TOLNAFTATE	Clinical Therapeutic Solutions	308a91d1-3511-4e2d-a62f-a31d77d70e06	2023-11-05	Warnings	Exact identifier application number: M005
Human Science Antifungal Foot Care	UNDECYLENIC ACID	HUMAN SCIENCE, LLC	26b2519b-7d7b-4b33-b5d6-a41fe6f73538	2023-11-05	Warnings	Exact identifier application number: M005
HomeHealth Antifungal	TOLNAFTATE	Home Health	895cd24c-3f78-4e2e-bf98-8bb6605798da	2023-11-05	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	Proficient Rx LP	800a9dab-d287-427e-af6d-26996e0def41	2023-11-01	Warnings	Exact identifier application number: M005
Povidone Iodine	POVIDONE-IODINE	Dr Radows	58e1757c-45ce-455e-bd64-a9e99cd3680f	2023-10-30	Warnings	Exact identifier application number: M005
JOCK-EZE	CLOTRIMAZOLE	Bentlin Products LLC	d3ff5bfb-2e0f-4daa-84b3-4a3016ca9280	2023-10-30	Warnings	Exact identifier application number: M005
TheraPlus Plus	CLOTRIMAZOLE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	de75179d-1889-4823-9f39-4bebdf185d76	2023-10-27	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