Monistat 3

Manufacturer: Insight Pharmaceuticals LLC
Effective date: 2025-10-23
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 01:40:45

Label at a glance#

ProductMonistat 3 3 Day

Active ingredientMiconazole Nitrate

Label structure10 sections

Dosage and administration

before using this product read the enclosed consumer information leaflet for complete directions and information adults and children 12 years of age and over: ▪ insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Throw applicator away after use. children under 12 years of age: ask a doctor

Contacts and useful links#

PhoneLabel contact877-666-4782

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate 4%

Purpose

OTC - PURPOSE SECTION

Vaginal antifungal

Use

INDICATIONS & USAGE SECTION

treats vaginal yeast infections

Warnings

WARNINGS SECTION

For vaginal use only

Do not use if

OTC - DO NOT USE SECTION

you have never had a vaginal yeast infection diagnosed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

vaginal itching and discomfort for the first time
lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
been exposed to human immunodeficiency virus (HIV) that causes AIDS

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

When using this product

OTC - WHEN USING SECTION

do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted disease (STDs).
do not have vaginal intercourse
mild increase in vaginal burning, itching, or irritation may occur
if you do not get complete relief ask a doctor before using another product

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms do not get better after 3 days
symptoms last more than 7 days
you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

before using this product read the enclosed consumer information leaflet for complete directions and information
adults and children 12 years of age and over:
▪ insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Throw applicator away after use.
children under 12 years of age: ask a doctor

Other information

OTHER SAFETY INFORMATION

do not use if printed applicator wrapper is torn, open or incompletely sealed
do not purchase if carton is open
store at 20° - 25°C (68° - 77°F)
Keep this carton for future reference. It contains important information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol

Questions?

OTC - QUESTIONS SECTION

If you have any questions or comments, please call 1-877-666-4782

PRINCIPAL DISPLAY PANEL - 5 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3-DAY TREATMENT

Prefilled Cream Applicator

MONISTAT^® 3
Miconazole Nitrate Vaginal Cream (4%)- Vaginal Antifungal

3 Prefilled Applicators Net Wt. 0.18 oz. (5g) each

3-DAY TREATMENT Prefilled Cream Applicator MONISTAT® 3 Miconazole Nitrate Vaginal Cream (4%)- Vaginal Antifungal 3 Prefilled Applicators Net Wt. 0.18 oz. (5g) each

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
998544	miconazole nitrate 4 % Vaginal Cream	PSN	7
998546	MONISTAT 3 4 % Vaginal Cream	PSN	7
998546	miconazole nitrate 40 MG/ML Vaginal Cream [Monistat]	SBD	7
998544	miconazole nitrate 40 MG/ML Vaginal Cream	SCD	7
998544	miconazole nitrate 4 % Vaginal Cream	SY	7
998546	Monistat 4 % Vaginal Cream	SY	7
998546	Monistat 40 MG/ML Vaginal Cream	SY	7

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
MICONAZOLE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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
63736-015-18	2020-02-20	C162847	48780-1	9d75b9cf-f73d-f424-e053-dadaa90a57ce	Monistat 3 3 Day 63736-015
63736-015-18	2020-02-20	C162847	48780-1	9d75b9cf-f73d-f424-e053-dadaa90a57ce	Monistat 3 3 Day 63736-015
63736-015-18	2020-01-31	C162847	48780-1	9d75b9cf-f73d-f424-e053-dadaa90a57ce	Monistat 3 3 Day 63736-015
63736-015-18	2020-01-31	C162847	48780-1	9d75b9cf-f73d-f424-e053-dadaa90a57ce	Monistat 3 3 Day 63736-015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63736-015-18	Monistat 33 Day	3 in 1 CARTON	CREAM	3	7
63736-015-18	Monistat 33 Day	5 g in 1 TUBE, WITH APPLICATOR	CREAM	5	7
63736-015-25	Monistat 33 Day	1 in 1 CARTON	CREAM	1	7
63736-015-25	Monistat 33 Day	25 g in 1 TUBE, WITH APPLICATOR	CREAM	25	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Miconazole Nitrate	ACTIVE INGREDIENT	VW4H1CYW1K	2
Miconazole	ACTIVE MOIETY	7NNO0D7S5M	2
Benzoic Acid	INACTIVE INGREDIENT	8SKN0B0MIM	2
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	2
Isopropyl Myristate	INACTIVE INGREDIENT	0RE8K4LNJS	2
Polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	2
Potassium Hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	2
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	2
Stearyl Alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

Monistat 3 3 Day
Miconazole Nitrate
Miconazole
Benzoic Acid
Cetyl Alcohol
Isopropyl Myristate
Polysorbate 60
Potassium Hydroxide
Propylene Glycol
Water
Stearyl Alcohol

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63736-015	63736-015-18, 63736-015-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Miconazole Nitrate	VW4H1CYW1K	ACTIB
Benzoic Acid	8SKN0B0MIM	IACT
Cetyl Alcohol	936JST6JCN	IACT
Isopropyl Myristate	0RE8K4LNJS	IACT
Polysorbate 60	CAL22UVI4M	IACT
Potassium Hydroxide	WZH3C48M4T	IACT
Propylene Glycol	6DC9Q167V3	IACT
Water	059QF0KO0R	IACT
Stearyl Alcohol	2KR89I4H1Y	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
6	2024-11-12	full-release	2026-06-01 00:36:24

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 21 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
Benzoic Acid	BENZOIC ACID	8SKN0B0MIM	CREAM / VAGINAL	10 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Benzoic Acid	BENZOIC ACID	8SKN0B0MIM	CREAM / VAGINAL	10 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL	1225 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Polysorbate 60	POLYSORBATE 60	CAL22UVI4M	CREAM / VAGINAL	200 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Potassium Hydroxide	POTASSIUM HYDROXIDE	WZH3C48M4T	CREAM / VAGINAL	3 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Polysorbate 60	POLYSORBATE 60	CAL22UVI4M	CREAM / VAGINAL	200 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	CREAM / VAGINAL	50 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL	1225 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Potassium Hydroxide	POTASSIUM HYDROXIDE	WZH3C48M4T	CREAM / VAGINAL	3 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Benzoic Acid	BENZOIC ACID	8SKN0B0MIM	CREAM / VAGINAL	10 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL	1225 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Potassium Hydroxide	POTASSIUM HYDROXIDE	WZH3C48M4T	CREAM / VAGINAL	3 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	CREAM / VAGINAL	200 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Stearyl Alcohol	STEARYL ALCOHOL	2KR89I4H1Y	CREAM / VAGINAL	425 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	CREAM / VAGINAL	200 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	CREAM / VAGINAL	50 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Polysorbate 60	POLYSORBATE 60	CAL22UVI4M	CREAM / VAGINAL	200 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Stearyl Alcohol	STEARYL ALCOHOL	2KR89I4H1Y	CREAM / VAGINAL	425 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	CREAM / VAGINAL	200 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	CREAM / VAGINAL	50 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Stearyl Alcohol	STEARYL ALCOHOL	2KR89I4H1Y	CREAM / VAGINAL	425 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020827-001	MONISTAT 3	MICONAZOLE NITRATE	4%	CREAM / VAGINAL		RLD, RS	1998-03-30

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`3a93d1ddd44b…`

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Monistat 3 3 Day	MICONAZOLE NITRATE	Insight Pharmaceuticals LLC	f38c7e1d-2439-4b3b-8be8-60b2d8e61ce5	2025-10-23	Warnings	Exact identifier ndc (package): 63736-015-25 ndc (package): 63736-015-18 ndc (product): 63736-015 ndc11 (package): 63736001518 ndc11 (package): 63736001525 spl id: 09cb5f1c-b40a-426f-94d0-ec18662feb0f spl set id: f38c7e1d-2439-4b3b-8be8-60b2d8e61ce5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.