MONISTAT 3 COMBINATION PACK_Ovule inserts-tube_63736-019-03

Manufacturer: Insight Pharmaceuticals LLC
Effective date: 2026-04-20
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 01:54:16

Label at a glance#

ProductMonistat 3 Combination Pack 3 Ovule Inserts

Active ingredientMiconazole Nitrate

Label structure10 sections

Indications and uses

treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection

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: ▪ vaginal insert : with a disposable applicator, place the insert into the vagina at bedtime for three nights in a row. Throw applicator away after use. ▪ external cream : squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy...

Contacts and useful links#

PhoneLabel contact1-877-666-4782

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate (200 mg in each vaginal insert)

Miconazole nitrate 2% (external cream)

Purpose

OTC - PURPOSE SECTION

Vaginal antifungal

Uses

INDICATIONS & USAGE SECTION

treats vaginal yeast infections
relieves external itching and irritation due to a vaginal yeast infection

Warnings

WARNINGS SECTION

For vaginal use only.

Do not use

OTC - DO NOT USE SECTION

if 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 the 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 diseases (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 in 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:
▪ vaginal insert : with a disposable applicator, place the insert into the vagina at bedtime for three nights in a row. Throw applicator away after use.
▪ external cream : squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed.
children under 12 years of age: ask a doctor.

Other information

OTHER SAFETY INFORMATION

do not use if printed sealed pouches containing vaginal inserts are torn, open or incompletely sealed
do not use if seal over tube opening has been punctured
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

vaginal insert: gelatin, glycerin, hydrogenated vegetable oil base, titanium dioxide

external cream: 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MONISTAT^® 3
COMBINATION PACK

Miconazole Nitrate Vaginal Inserts (200 mg) and
Miconazole Nitrate Vaginal Cream (2%) – Vaginal Antifungal

3 OVULE^®Inserts Net Wt. 2.5 g each

+ 0.32 oz (9 g) Tube

MONISTAT® 3 COMBINATION PACK Miconazole Nitrate Vaginal Inserts (200 mg) and Miconazole Nitrate Vaginal Cream (2%) – Vaginal Antifungal 3 OVULE® Inserts Net Wt. 2.5 g each + 0.3...

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
992771	{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]) / 3 (miconazole nitrate 200 MG Vaginal Insert [Monistat]) } Pack [Monistat 3 Day Ovule Combination Pack]	BPCK	5
992766	{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } Pack	GPCK	5
998540	miconazole nitrate 2 % Vaginal Cream	PSN	5
992765	miconazole nitrate 200 MG Vaginal Insert	PSN	5
992766	miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) Pack	PSN	5
998541	Monistat 2 % Vaginal Cream	PSN	5
992770	Monistat 3 200 MG Vaginal Insert	PSN	5
992771	Monistat 3 Day Ovule Combination Pack	PSN	5
998541	miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]	SBD	5
992770	miconazole nitrate 200 MG Vaginal Insert [Monistat]	SBD	5
998540	miconazole nitrate 20 MG/ML Vaginal Cream	SCD	5
992765	miconazole nitrate 200 MG Vaginal Insert	SCD	5
992771	{1 (0.32 OZ) (miconazole nitrate 2 % Vaginal Cream [Monistat]) / 3 (miconazole nitrate 200 MG Vaginal Insert [Monistat]) } Pack [Monistat 3 Day Ovule Combination Pack]	SY	5
992766	miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)	SY	5
992766	miconazole 3 Day Vaginal Insert Combination Pack	SY	5
998540	miconazole nitrate 2 % Vaginal Cream	SY	5
998541	Monistat 20 MG/ML Vaginal Cream	SY	5
992770	Monistat 200 MG Vaginal Insert	SY	5
992771	Monistat 3 Day Ovule Combination Pack	SY	5

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63736-019-03	Monistat 3 Combination Pack3 Ovule Inserts	1 in 1 PACKAGE, COMBINATION	KIT	1		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Miconazole Nitrate	ACTIVE INGREDIENT	VW4H1CYW1K	1
Miconazole	ACTIVE MOIETY	7NNO0D7S5M	1
Benzoic Acid	INACTIVE INGREDIENT	8SKN0B0MIM	1
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	1
Gelatin	INACTIVE INGREDIENT	2G86QN327L	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
Isopropyl Myristate	INACTIVE INGREDIENT	0RE8K4LNJS	1
Polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	1
Potassium Hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
Stearyl Alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Monistat 3 Combination Pack 3 Ovule Inserts
Miconazole Nitrate
Miconazole
GELATIN
GLYCERIN
CORN OIL
TITANIUM DIOXIDE
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
63736-019	63736-019-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Miconazole Nitrate	VW4H1CYW1K	ACTIB
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
CORN OIL	8470G57WFM	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
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

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 12 · 678 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Polysorbate 60	POLYSORBATE 60	CAL22UVI4M	AEROSOL, FOAM / TOPICAL		30 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 150 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 80 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii candidate 162 equally ranked IID candidates
Benzoic Acid	BENZOIC ACID	8SKN0B0MIM	SOLUTION / IRRIGATION	0.02 %w/v		Exact identifier — unii candidate 46 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 80 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii candidate 162 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL / TOPICAL		29 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 150 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii candidate 162 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / RECTAL		27 mg	Exact identifier — unii candidate 162 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 150 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii candidate 150 equally ranked IID candidates
Polysorbate 60	POLYSORBATE 60	CAL22UVI4M	OINTMENT / TOPICAL	2 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 80 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii candidate 80 equally ranked IID candidates
Polysorbate 60	POLYSORBATE 60	CAL22UVI4M	SHAMPOO / TOPICAL	14.55 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 150 equally ranked IID candidates
Benzoic Acid	BENZOIC ACID	8SKN0B0MIM	INJECTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 46 equally ranked IID candidates
Benzoic Acid	BENZOIC ACID	8SKN0B0MIM	INJECTION, SOLUTION / INTRAMUSCULAR	0.2 %w/v		Exact identifier — unii candidate 46 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 162 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 150 equally ranked IID candidates
Gelatin	GELATIN	2G86QN327L	GUM, CHEWING / BUCCAL		102 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii candidate 162 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 150 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GUM, CHEWING / BUCCAL		182 mg	Exact identifier — unii candidate 80 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 150 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 150 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii candidate 80 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 150 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 150 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 150 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	OIL / TOPICAL		213 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii candidate 162 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 150 equally ranked IID candidates
Polysorbate 60	POLYSORBATE 60	CAL22UVI4M	SUPPOSITORY / RECTAL	0.05 mg/mg		Exact identifier — unii candidate 26 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / RECTAL		27 mg	Exact identifier — unii candidate 162 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 150 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 80 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / VAGINAL	0.75 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL / TOPICAL	9.3 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 80 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	INSERT, EXTENDED RELEASE / OPHTHALMIC	0.4 mg		Exact identifier — unii candidate 80 equally ranked IID candidates
Gelatin	GELATIN	2G86QN327L	CAPSULE, EXTENDED RELEASE / ORAL		1229 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Stearyl Alcohol	STEARYL ALCOHOL	2KR89I4H1Y	AEROSOL, FOAM / TOPICAL		37 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 80 equally ranked IID candidates
Benzoic Acid	BENZOIC ACID	8SKN0B0MIM	SUSPENSION / ORAL	15 mg		Exact identifier — unii candidate 46 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 150 equally ranked IID candidates
Stearyl Alcohol	STEARYL ALCOHOL	2KR89I4H1Y	CAPSULE, EXTENDED RELEASE / ORAL	72 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 150 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 150 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 162 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / RESPIRATORY (INHALATION)	25 %w/w		Exact identifier — unii candidate 162 equally ranked IID candidates
Potassium Hydroxide	POTASSIUM HYDROXIDE	WZH3C48M4T	SOLUTION / INTRAVASCULAR	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	DROPS / ORAL	NA		Exact identifier — unii candidate 80 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM, AUGMENTED / TOPICAL	8 %w/w		Exact identifier — unii candidate 162 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 162 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 162 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	OIL / AURICULAR (OTIC)		36 mg	Exact identifier — unii candidate 36 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 43.

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
N020670-002	MONISTAT 3 COMBINATION PACK	MICONAZOLE NITRATE	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL		RLD, RS	1996-04-16

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`f41ea6bd6efb…`

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 Combination Pack 3 Ovule Inserts	MICONAZOLE NITRATE	Insight Pharmaceuticals LLC	910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd	2026-04-20	Warnings	Exact identifier ndc (package): 63736-019-03 ndc (product): 63736-019 ndc11 (package): 63736001903 spl id: 9fd5cf39-5662-42fa-8d8c-8b96dce19875 spl set id: 910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd

Reported adverse events (FAERS/openFDA)#

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