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 39 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Terrasil Anti-Fungal Treatment MAX	CLOTRIMAZOLE	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	db356cc8-f473-4eb2-b8d8-72606fca9dc0	2025-05-23	Warnings	Exact identifier application number: M005
terrasil Folliculitis Cream Maximum Strength	CLOTRIMAZOLE	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	35d54756-00dd-bbe1-e063-6394a90a9e02	2025-05-23	Warnings	Exact identifier application number: M005
Paume Moisturizing Antibacterial Hand Gel	ALCOHOL	Paume Inc	b6fe12bf-6430-5861-e053-2a95a90a6c8f	2025-05-22	Warnings	Exact identifier application number: M005
Tolnaftate Cream 1% ANTIFUNGAL	TOLNAFTATE	Trifecta Pharmaceuticals Usa Llc	96a40ccd-17f7-4e4e-98da-207802fa2b2d	2025-05-15	Warnings	Exact identifier application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	Cardinal Health 110 dba LEADER	34f4c733-2eb2-0db0-e063-6394a90a6431	2025-05-13	Warnings	Exact identifier application number: M005
Dr CANUSO fungal nail eraser	TOLNAFTATE OIL	Renu Laboratories, LLC	2083f9ed-09d6-26e6-e054-00144ff88e88	2025-05-13	Warnings	Exact identifier application number: M005
Dr. Canuso foot repair serum	TOLNAFTATE SERUM	Renu Laboratories, LLC	1fcc52c5-7030-13cb-e054-00144ff8d46c	2025-05-13	Warnings	Exact identifier application number: M005
Private Label Antifungal Barrier Cream	MICONAZOLE NITRATE ANTIFUNGAL CREAM	Swiss-American CDMO, LLC	2ee40c37-504b-43ed-960a-535015407492	2025-05-09	Warnings	Exact identifier application number: M005
Osimoon Fungal Nail Treatment Kit	OSIMOON FUNGAL NAIL TREATMENT KIT	Guangzhou Zanming Trading Co., Ltd.	34aec10d-a0d0-d956-e063-6394a90a39b2	2025-05-09	Warnings	Exact identifier application number: M005
ANTIFUNGAL	MICONAZOLE	VIVE HEALTH LLC	33d9c724-d4c4-2597-e063-6294a90aa5f3	2025-04-28	Warnings	Exact identifier application number: M005
ANTIFUNGAL	CLOTRIMAZOLE	VIVE HEALTH LLC	33db98f5-f6d9-742a-e063-6394a90a2a03	2025-04-28	Warnings	Exact identifier application number: M005
Foot Cure Nail Repair Pen	ANTIFUNGAL NAIL REPAIR PEN	SANSAR, LLC	9c823e27-8bb3-4ccd-bf7e-a99d45908e88	2025-04-25	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER CUCUMBER MELON	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	3380404d-9499-e9fb-e063-6394a90a0f27	2025-04-24	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER SWEET GUAVA FRESH COCONUT	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	3380fe6d-e059-401a-e063-6394a90a787a	2025-04-24	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER DRAGONFRUIT JASMINE	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	3381cefb-281c-9b85-e063-6294a90acfd9	2025-04-24	Warnings	Exact identifier application number: M005
Wish Hand Sanitizer Coconut Cream White Florals	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	33826aef-6e50-2730-e063-6394a90a727b	2025-04-24	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER GOLDEN CITRUS	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	3391a78e-525d-c2ba-e063-6394a90a1e99	2025-04-24	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER SALTED CARAMEL PISTACHIO	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	33927939-a9dc-ab67-e063-6394a90a71cc	2025-04-24	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER BLACK PLUM VANILLA	ALCOHOL HAND SANITIZER	PT. SUPER HOME PRODUCT INDONESIA	336c751f-6a33-ca55-e063-6394a90a9749	2025-04-23	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER VIOLET ORCHID SANDALWOOD	ALCOHOL HAND SANITIZER	PT. SUPER HOME PRODUCT INDONESIA	337e4526-238a-bc2d-e063-6394a90a5a27	2025-04-23	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