Monistat 1 COMBINATION PACK_Suppository-tube_63736-013-30

Manufacturer: Insight Pharmaceuticals LLC
Effective date: 2026-04-20
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 01:54:01

Label at a glance#

ProductMonistat 1 Combination Pack

Active ingredientMiconazole Nitrate

Label structure9 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 the applicator, place the vaginal insert into the vagina. Throw away applicator. 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 f...

Contacts and useful links#

PhoneLabel contact1-877-666-4782

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Purpose

OTC - PURPOSE SECTION

Miconazole nitrate 1200 mg (in each vaginal insert) Vaginal antifungal

Miconazole nitrate 2% (external cream) 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 the applicator, place the vaginal insert into the vagina. Throw away applicator.
- 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 pouch is 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)
this is a 1-dose treatment. Most women do not get complete relief of their symptoms in just 1 day. Most women get some improvement in 1 day and complete relief by 7 days.
Keep this carton for future reference. It contains important information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

vaginal insert: gelatin, glycerin, lecithin, mineral oil, titanium dioxide, white petrolatum

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

1-DAY
TREATMENT

Day or Night Stays in Place

MONISTAT® 1
COMBINATION PACK

Miconazole Nitrate Vaginal Insert (1200 mg) and
Miconazole Nitrate Cream (2%) – Vaginal Antifungal
1-DAY
TREATMENT
MAXIMUM STRENGTH

1 OVULE^® Insert Net Wt. 2.6 g +0.32oz (9g) Tube

1-DAY TREATMENT Day or Night Stays in Place MONISTAT® 1 COMBINATION PACK Miconazole Nitrate Vaginal Insert (1200 mg) and Miconazole Nitrate Cream (2%) – Vaginal Antifungal 1-DAY...

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
992778	{1 (miconazole nitrate 1200 MG Vaginal Insert [Monistat]) / 1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]) } Pack [Monistat 1 Day Ovule Combination Pack]	BPCK	7
992775	{1 (miconazole nitrate 1200 MG Vaginal Insert) / 1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) } Pack	GPCK	7
992775	miconazole 1 day - (1200 MG insert / 2 % cream 9 GM) Pack	PSN	7
992774	miconazole nitrate 1200 MG Vaginal Insert	PSN	7
998540	miconazole nitrate 2 % Vaginal Cream	PSN	7
992778	Monistat 1 Day Ovule Combination Pack	PSN	7
992777	Monistat 1200 MG Vaginal Insert	PSN	7
998541	Monistat 2 % Vaginal Cream	PSN	7
992777	miconazole nitrate 1200 MG Vaginal Insert [Monistat]	SBD	7
998541	miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]	SBD	7
992774	miconazole nitrate 1200 MG Vaginal Insert	SCD	7
998540	miconazole nitrate 20 MG/ML Vaginal Cream	SCD	7
992778	{1 (miconazole nitrate 1200 MG Vaginal Insert [Monistat]) / 1 (0.32 OZ) (miconazole nitrate 2 % Vaginal Cream [Monistat]) } Pack [Monistat 1 Day Ovule Combination Pack]	SY	7
992774	miconazole nitrate 1.2 GM Vaginal Insert	SY	7
998540	miconazole nitrate 2 % Vaginal Cream	SY	7
992778	Monistat 1 Day Ovule Combination Pack	SY	7
992777	Monistat 1200 MG Vaginal Insert	SY	7
998541	Monistat 20 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
63736-013-30	2020-02-20	C162847	48780-1	9d75b9d0-9fd9-f424-e053-dadaa90a57ce	Monistat 1 COMBINATION PACK_Suppository-tube_63736-013-30
63736-013-30	2020-01-31	C162847	48780-1	9d75b9d0-9fd9-f424-e053-dadaa90a57ce	Monistat 1 COMBINATION PACK_Suppository-tube_63736-013-30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63736-013-30	Monistat 1 Combination Pack	1 in 1 PACKAGE, COMBINATION	KIT	1		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
Gelatin	INACTIVE INGREDIENT	2G86QN327L	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	2
Isopropyl Myristate	INACTIVE INGREDIENT	0RE8K4LNJS	2
Mineral Oil	INACTIVE INGREDIENT	T5L8T28FGP	2
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	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
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Monistat 1 Combination Pack
Miconazole Nitrate
Miconazole
GELATIN
GLYCERIN
LECITHIN, SOYBEAN
MINERAL OIL
TITANIUM DIOXIDE
PETROLATUM
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
63736-013	63736-013-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Miconazole Nitrate	VW4H1CYW1K	ACTIB
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
LECITHIN, SOYBEAN	1DI56QDM62	IACT
MINERAL OIL	T5L8T28FGP	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
PETROLATUM	4T6H12BN9U	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 · Source PDF

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 13 · 774 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii candidate 150 equally ranked IID candidates
Polysorbate 60	POLYSORBATE 60	CAL22UVI4M	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL		1072 mg	Exact identifier — unii candidate 162 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	PASTE / DENTAL	95 %w/w		Exact identifier — unii candidate 60 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 150 equally ranked IID candidates
Gelatin	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	14 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SUSPENSION / TOPICAL	82 %w/w		Exact identifier — unii candidate 60 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL, METERED / TRANSDERMAL		50 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 162 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii candidate 150 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 60 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, COATED / ORAL	1.5 mg		Exact identifier — unii candidate 60 equally ranked IID candidates
Polysorbate 60	POLYSORBATE 60	CAL22UVI4M	LOTION / TOPICAL	5 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 150 equally ranked IID candidates
Gelatin	GELATIN	2G86QN327L	SYRUP / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO, SUSPENSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 162 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SUSPENSION / OPHTHALMIC	0.1 %w/w		Exact identifier — unii candidate 60 equally ranked IID candidates
Stearyl Alcohol	STEARYL ALCOHOL	2KR89I4H1Y	POWDER / ORAL	0.11 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 150 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SYSTEM / TOPICAL	654.36 mg		Exact identifier — unii candidate 60 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 80 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / TOPICAL		82 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii candidate 162 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPONGE / TOPICAL	40 %w/w		Exact identifier — unii candidate 162 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 150 equally ranked IID candidates
Stearyl Alcohol	STEARYL ALCOHOL	2KR89I4H1Y	OINTMENT / TOPICAL		569 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Gelatin	GELATIN	2G86QN327L	PASTE / DENTAL		252 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Benzoic Acid	BENZOIC ACID	8SKN0B0MIM	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 46 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 150 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / OPHTHALMIC	1.5 %w/v		Exact identifier — unii candidate 162 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 150 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 80 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 150 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 162 equally ranked IID candidates
Polysorbate 60	POLYSORBATE 60	CAL22UVI4M	CREAM / VAGINAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 150 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	FILM / TRANSDERMAL	58.08 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii candidate 80 equally ranked IID candidates
Gelatin	GELATIN	2G86QN327L	TABLET, ORALLY DISINTEGRATING / SUBLINGUAL		13 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	SYSTEM / TRANSDERMAL		113 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 150 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 150 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 162 equally ranked IID candidates
Gelatin	GELATIN	2G86QN327L	INJECTION / SUBCUTANEOUS	16 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 150 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, ORALLY DISINTEGRATING / ORAL		9 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Stearyl Alcohol	STEARYL ALCOHOL	2KR89I4H1Y	AEROSOL, FOAM / TOPICAL		37 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 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
Mineral Oil	MINERAL OIL	T5L8T28FGP	OIL / TOPICAL	43.29 %v/v		Exact identifier — unii candidate 60 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / RESPIRATORY (INHALATION)	2 mg		Exact identifier — unii candidate 80 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii candidate 80 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 162 equally ranked IID candidates
Gelatin	GELATIN	2G86QN327L	TABLET, CHEWABLE / ORAL		24 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 150 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 162 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 80 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 162 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAVENOUS		16624 mg	Exact identifier — unii candidate 162 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
N021308-001	MONISTAT 1 COMBINATION PACK	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL		RLD, RS	2001-06-29

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	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`f41ea6bd6efb…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021308-001	6153635	2020-11-28	Delist requested	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021308-001	6153635	2020-11-28	Delist requested	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021308-001	6153635	2020-11-28	Delist requested	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021308-001	6153635	2020-11-28	Delist requested	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021308-001	6153635	2020-11-28	Delist requested	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021308-001	6153635	2020-11-28	Delist requested	`ea99ee380514…`

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 1 Combination Pack	MICONAZOLE NITRATE	Insight Pharmaceuticals LLC	97ff1c90-c250-4921-81af-6a56cc9cc7d2	2026-04-20	Warnings	Exact identifier ndc (package): 63736-013-30 ndc (product): 63736-013 ndc11 (package): 63736001330 spl id: 50061b4b-e817-4ed7-8f2f-be4a17baf152 spl set id: 97ff1c90-c250-4921-81af-6a56cc9cc7d2

Reported adverse events (FAERS/openFDA)#

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