FDA.reportPublic FDA data

NDC 51672-1275-01 - Clotrimazole

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
51672-1275
Requested NDC
51672-1275-01
Package NDCs from labels
51672-1275-1, 51672-1275-2, 51672-1275-6, 51672-1275-7, 51672-1275-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2025-09-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Clotrimazole Cream USP, 1%Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-09-10HUMAN PRESCRIPTION DRUG LABEL
Clotrimazole Cream USP, 1%REMEDYREPACK INC.2024-03-15HUMAN PRESCRIPTION DRUG LABEL
Clotrimazole - A-S Medication SolutionsA-S Medication Solutions2023-11-22HUMAN PRESCRIPTION DRUG LABEL
Clotrimazole - Proficient Rx LPProficient Rx LP2022-02-01HUMAN PRESCRIPTION DRUG LABEL
Clotrimazole Cream USP, 1%NuCare Pharmaceuticals,Inc.2022-01-14HUMAN PRESCRIPTION DRUG LABEL
Clotrimazole Cream USP, 1%NuCare Pharmaceuticals,Inc.2021-07-06HUMAN PRESCRIPTION DRUG LABEL
Clotrimazole - Physicians Total Care, Inc.Physicians Total Care, Inc.2011-03-16HUMAN OTC DRUG LABEL
CLOTRIMAZOLE - STAT RX USA LLCSTAT RX USA LLC2010-08-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1275-1Clotrimazole1 in 1 CARTONCREAM18
51672-1275-1Clotrimazole15 g in 1 TUBECREAM158
51672-1275-2Clotrimazole1 in 1 CARTONCREAM18
51672-1275-2Clotrimazole30 g in 1 TUBECREAM308
51672-1275-6Clotrimazole45 g in 1 TUBECREAM458
51672-1275-6Clotrimazole1 in 1 CARTONCREAM18
51672-1275-7Clotrimazole45 g in 1 TUBECREAM458
51672-1275-7Clotrimazole2 in 1 CARTONCREAM28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1275CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 8 package rows20241222_77883cfd-f13c-40cb-88b2-8f777e1cdce9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1275-1GM - Gram51672-1275593d29e0-4cba-46cc-a57d-5c9bf5e9529312012-07-24
51672-1275-2GM - Gram51672-1275e0172989-2c5a-4d8c-a2f9-4fa2ab03afe312012-07-24
51672-1275-6GM - Gram51672-127518918d69-9395-4a2e-a101-5f77f5ef6fec12012-07-24
51672-1275-7GM - Gram51672-12751c0757eb-637f-4136-b40b-c8282abd88ea12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ClotrimazoleACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
ClotrimazoleACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
cetyl esters waxINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
Sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [STAT RX USA LLC]1
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [STAT RX USA LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [STAT RX USA LLC]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE CREAM [STAT RX USA LLC]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE CREAM [STAT RX USA LLC]1
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
OCTYLDODECYL STEARATEINACTIVE INGREDIENTK6F16QGO28CLOTRIMAZOLE CREAM [STAT RX USA LLC]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE CREAM [STAT RX USA LLC]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE CREAM [STAT RX USA LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE CREAM [STAT RX USA LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1

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 8 of 22 · 434 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLOTRIMAZOLECLOTRIMAZOLEGRAXCELL PHARMACEUTICAL, LLC.5f8ca6ad-cb25-1abf-e053-2a91aa0aca992025-12-25WarningsExact identifier
unii: G07GZ97H65
Terthon Clotrimazole 1% Antifungal CreamCLOTRIMAZOLE 1%SOLALIA LLC468f1b1b-f67d-8b98-e063-6294a90a7f452025-12-22WarningsExact identifier
rxcui: 309367
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEGranules USA, Inc.6e63e29a-eb50-1790-e053-2a91aa0a36162025-12-22WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLERUGBY LABORATORIES6de9155b-7070-38fd-e053-2a91aa0af6f62025-12-19WarningsExact identifier
unii: G07GZ97H65
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: LKG8494WBH
AlevazolCLOTRIMAZOLECapital Pharmaceutical, LLCedd8da89-0b83-4de6-a166-7451d00841692025-12-12WarningsExact identifier
unii: G07GZ97H65
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
ClotrimazoleCLOTRIMAZOLEA-S Medication Solutions1e7e74f6-9bca-48ab-804a-a7a81df3b6082025-12-05WarningsExact identifier
rxcui: 309367
unii: G07GZ97H65
Oiangna Tea Tree Oil AntifungalCLOTRIMAZOLE 1%Guangzhou Huixue Biotechnology Co., Ltd.453452a7-c613-6111-e063-6294a90aca812025-12-05WarningsExact identifier
unii: G07GZ97H65
LotriminCLOTRIMAZOLEBayer HealthCare LLC.b584e17f-ed43-43bd-b643-dfa48edd78c62025-12-05WarningsExact identifier
rxcui: 309367
unii: G07GZ97H65
Fungicure Night CreamCLOTRIMAZOLEKobayashi Healthcare International, Inc.43029403-2afd-cfa1-e063-6394a90a99a32025-12-04WarningsExact identifier
rxcui: 309367
unii: G07GZ97H65
Lotrimin AntifungalCLOTRIMAZOLEBayer HealthCare LLC.f9536683-3f32-4c71-9b6a-70f8611e3dcf2025-12-04WarningsExact identifier
rxcui: 309367
unii: G07GZ97H65
LotriminCLOTRIMAZOLEBayer HealthCare LLCda948ef3-3709-4bfc-9d17-f6f1ea3253432025-12-04WarningsExact identifier
rxcui: 309367
unii: G07GZ97H65
WELMATE Clotrimazole Topical SolutionCLOTRIMAZOLEYYBA CORPdc5bac4a-938c-4678-89ac-a899440c6a3c2025-12-02WarningsExact identifier
unii: G07GZ97H65
Thermacare Max Strength LidocaineTHERMACARE MAX STRENGTH LIDOCAINEClarion Brands LLC44fed887-d1e0-d205-e063-6294a90ac4162025-12-02WarningsExact identifier
unii: LKG8494WBH
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Inc0a6cb1f7-a2a2-46a2-ae63-d205318996f02025-12-01WarningsExact identifier
rxcui: 309367
unii: G07GZ97H65
TrimazoleCLOTRIMAZOLETrifluent Pharma LLCa3bafc52-1404-4e0b-84c1-e28bffcb091e2025-12-01WarningsExact identifier
rxcui: 309367
unii: G07GZ97H65
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief RollonTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLONClarion Brands LLC4482d34d-eaca-5522-e063-6394a90a6afb2025-11-26WarningsExact identifier
unii: LKG8494WBH
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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