FDA.reportPublic FDA data

Miconazole Nitrate

Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2026-08-25
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-08-27 00:01:51

Label at a glance#

ProductMiconazole Nitrate
Active ingredientMICONAZOLE NITRATE
Label structure12 sections

Indications and uses

effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) for effective relief of itching, scaling, burning and discomfort that can accompany these conditions.

Dosage and administration

clean the affected area and dry thoroughly apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily For athlete's foot and ringworm: use daily for 4 weeks. For jo...

Storage and handling

To open: unscrew cap, use pointed end on cap to puncture seal store at 20° - 25°C (68° - 77°F) see carton or tube crimp for lot number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate USP 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • for effective relief of itching, scaling, burning and discomfort that can accompany these conditions.

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not useon children less than 2 years of age unless directed by a doctor

OTC - WHEN USING SECTION

When using this productavoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • condition persists
  • there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • For athlete's foot and ringworm: use daily for 4 weeks.
  • For jock itch: use daily for 2 weeks
  • not effective on the scalp or nails

Other information

STORAGE AND HANDLING SECTION

  • To open: unscrew cap, use pointed end on cap to puncture seal
  • store at 20° - 25°C (68° - 77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

apricot kernel oil, benzoic acid, BHT, glycol stearate, mineral oil, PEG-6, PEG-6-32 stearate, purified water

Questions?

OTC - QUESTIONS SECTION

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:

Ohm Laboratories Inc.

New Brunswick, NJ 08901

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51672-2002-1

Cures Most Athlete's Foot

Antifungal Cream

Miconazole Nitrate
Cream USP, 2%
Antifungal Cream

NET WT 1/2 oz (15 g)

miconazolemiconazole

PRINCIPAL DISPLAY PANEL - 15 g Tube CartonPRINCIPAL DISPLAY PANEL - 15 g Tube Carton

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51672-2001-2
Cures Most Athlete’s Foot
Miconazole Nitrate
Cream USP, 2%
Antifungal
NET WT 1 oz (30 g)
miconazolemiconazole

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2001-1GM - Gram51672-20019dbd7e37-8219-4939-b49c-0359e914af9712012-07-24
51672-2001-2GM - Gram51672-20019cf50338-1157-450f-91bd-7c055b0d494812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1K2
MiconazoleACTIVE MOIETY7NNO0D7S5M2
apricot kernel oilINACTIVE INGREDIENT54JB35T06A2
benzoic acidINACTIVE INGREDIENT8SKN0B0MIM2
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171K2
glycol stearateINACTIVE INGREDIENT0324G66D0E2
mineral oilINACTIVE INGREDIENTT5L8T28FGP2
PEG-32 stearateINACTIVE INGREDIENT33GX5WQC0M2
PEG-6 stearateINACTIVE INGREDIENT8LQC57C6B02
polyethylene glycol 300INACTIVE INGREDIENT5655G9Y8AQ2
waterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51672-200151672-2001-1, 51672-2001-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICONAZOLE NITRATEVW4H1CYW1KACTIB
APRICOT KERNEL OIL54JB35T06AIACT
BENZOIC ACID8SKN0B0MIMIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
GLYCOL STEARATE0324G66D0EIACT
MINERAL OILT5L8T28FGPIACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
WATER059QF0KO0RIACT
PEG-6 STEARATE8LQC57C6B0IACT
PEG-32 STEARATE33GX5WQC0MIACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72026-08-05daily-update2026-08-08 02:01:14
52025-07-03full-release2026-06-01 01:06:30

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 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
polyethylene glycol 300POLYETHYLENE GLYCOL 3005655G9Y8AQCREAM / TOPICAL20 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
butylated hydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
benzoic acidBENZOIC ACID8SKN0B0MIMCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
benzoic acidBENZOIC ACID8SKN0B0MIMCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
glycol stearateGLYCOL STEARATE0324G66D0ECREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
glycol stearateGLYCOL STEARATE0324G66D0ECREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
glycol stearateGLYCOL STEARATE0324G66D0ECREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
polyethylene glycol 300POLYETHYLENE GLYCOL 3005655G9Y8AQCREAM / TOPICAL20 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
benzoic acidBENZOIC ACID8SKN0B0MIMCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
polyethylene glycol 300POLYETHYLENE GLYCOL 3005655G9Y8AQCREAM / TOPICAL20 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole NitrateMICONAZOLE NITRATESun Pharmaceutical Industries, Inc.7fd4037e-d350-47b7-a7d9-a43b8e366fa02026-08-25WarningsExact identifier
ndc (package): 51672-2001-2
ndc (package): 51672-2001-1
ndc (product): 51672-2001
ndc11 (package): 51672200101
ndc11 (package): 51672200102
spl id: 59d8ccc0-136d-dfa7-e063-6394a90adde1
spl set id: 7fd4037e-d350-47b7-a7d9-a43b8e366fa0

Reported adverse events (FAERS/openFDA)#

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