FDA.reportPublic FDA data

NDC 51672-2001-01 - Miconazole Nitrate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
51672-2001
Requested NDC
51672-2001-01
Package NDCs from labels
51672-2001-1, 51672-2001-2, 51672-2001-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2026-08-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Miconazole NitrateSun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2026-08-25HUMAN OTC DRUG LABEL
Miconazole Nitrate - A-S Medication SolutionsA-S Medication Solutions2025-12-03HUMAN OTC DRUG LABEL
Miconazole Nitrate - A-S Medication SolutionsA-S Medication Solutions2025-02-24HUMAN OTC DRUG LABEL
Miconazole NitrateNuCare Pharmaceuticals,Inc.2022-03-15HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2001-1Miconazole Nitrate1 in 1 CARTONCREAM15
51672-2001-1Miconazole Nitrate15 g in 1 TUBECREAM155
51672-2001-2Miconazole Nitrate1 in 1 CARTONCREAM15
51672-2001-2Miconazole Nitrate30 g in 1 TUBECREAM305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2001MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4Current NDC, Legacy NDC, 4 package rows20241222_7fd4037e-d350-47b7-a7d9-a43b8e366fa0.zip

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
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
MiconazoleACTIVE MOIETY7NNO0D7S5MMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
apricot kernel oilINACTIVE INGREDIENT54JB35T06AMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
benzoic acidINACTIVE INGREDIENT8SKN0B0MIMMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
glycol stearateINACTIVE INGREDIENT0324G66D0EMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
mineral oilINACTIVE INGREDIENTT5L8T28FGPMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
PEG-32 stearateINACTIVE INGREDIENT33GX5WQC0MMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
PEG-6 stearateINACTIVE INGREDIENT8LQC57C6B0MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
polyethylene glycol 300INACTIVE INGREDIENT5655G9Y8AQMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
waterINACTIVE INGREDIENT059QF0KO0RMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2

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 49 of 70 · 1,400 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Canuso foot repair serumTOLNAFTATE SERUMRenu Laboratories, LLC1fcc52c5-7030-13cb-e054-00144ff8d46c2025-05-13WarningsExact identifier
application number: M005
Private Label Antifungal Barrier CreamMICONAZOLE NITRATE ANTIFUNGAL CREAMSwiss-American CDMO, LLC2ee40c37-504b-43ed-960a-5350154074922025-05-09WarningsExact identifier
application number: M005
unii: VW4H1CYW1K
Osimoon Fungal Nail Treatment KitOSIMOON FUNGAL NAIL TREATMENT KITGuangzhou Zanming Trading Co., Ltd.34aec10d-a0d0-d956-e063-6394a90a39b22025-05-09WarningsExact identifier
application number: M005
ANTIFUNGALMICONAZOLEVIVE HEALTH LLC33d9c724-d4c4-2597-e063-6294a90aa5f32025-04-28WarningsExact identifier
application number: M005
ANTIFUNGALCLOTRIMAZOLEVIVE HEALTH LLC33db98f5-f6d9-742a-e063-6394a90a2a032025-04-28WarningsExact identifier
application number: M005
Foot Cure Nail Repair PenANTIFUNGAL NAIL REPAIR PENSANSAR, LLC9c823e27-8bb3-4ccd-bf7e-a99d45908e882025-04-25WarningsExact identifier
application number: M005
WISH HAND SANITIZER CUCUMBER MELONALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA3380404d-9499-e9fb-e063-6394a90a0f272025-04-24WarningsExact identifier
application number: M005
WISH HAND SANITIZER SWEET GUAVA FRESH COCONUTALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA3380fe6d-e059-401a-e063-6394a90a787a2025-04-24WarningsExact identifier
application number: M005
WISH HAND SANITIZER DRAGONFRUIT JASMINEALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA3381cefb-281c-9b85-e063-6294a90acfd92025-04-24WarningsExact identifier
application number: M005
Wish Hand Sanitizer Coconut Cream White FloralsALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA33826aef-6e50-2730-e063-6394a90a727b2025-04-24WarningsExact identifier
application number: M005
WISH HAND SANITIZER GOLDEN CITRUSALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA3391a78e-525d-c2ba-e063-6394a90a1e992025-04-24WarningsExact identifier
application number: M005
WISH HAND SANITIZER SALTED CARAMEL PISTACHIOALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA33927939-a9dc-ab67-e063-6394a90a71cc2025-04-24WarningsExact identifier
application number: M005
Miconazole 3MICONAZOLE NITRATECVS Pharmacy9f506f59-e435-465d-90c7-9b0edc44160d2025-04-24WarningsExact identifier
rxcui: 998483
WISH HAND SANITIZER BLACK PLUM VANILLAALCOHOL HAND SANITIZERPT. SUPER HOME PRODUCT INDONESIA336c751f-6a33-ca55-e063-6394a90a97492025-04-23WarningsExact identifier
application number: M005
WISH HAND SANITIZER VIOLET ORCHID SANDALWOODALCOHOL HAND SANITIZERPT. SUPER HOME PRODUCT INDONESIA337e4526-238a-bc2d-e063-6394a90a5a272025-04-23WarningsExact identifier
application number: M005
ELLEN HAND SANITIZER2ETHYL ALCOHOLPT. SUPER HOME PRODUCT INDONESIA334574b6-6d4a-bd37-e063-6394a90a67d62025-04-21WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEGERI-GENTLE CORPORATIONe6734616-c16b-430c-e053-2a95a90a18f82025-04-21WarningsExact identifier
application number: M005
rxcui: 998483
unii: VW4H1CYW1K
Clotrimazole 1% Athletes FootCLOTRIMAZOLEGERI-GENTLE CORPORATIONe673748f-d00b-4ce8-e053-2995a90a92202025-04-21WarningsExact identifier
application number: M005
PHYTOZINE RINGWORM TREATMENT MAXIMUM STRENGTHTOLNAFTATEThe Sisquoc Healthcare Corporation5dff6ee7-f7a9-4841-8357-6b0801d253f12025-04-21WarningsExact identifier
application number: M005
HAND SANITIZERALCOHOLNINGBO TIANBO FIRST AID PRODUCT CO., LTD.88a14b15-09d6-45de-97b6-cddce7ca420b2025-04-19WarningsExact identifier
application number: M005

Reported adverse events (FAERS/openFDA)#

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