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 10 of 22 · 434 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Family Care AntifungalCLOTRIMAZOLEUnited Exchange Corp.63255079-ecf1-1e77-e053-2a91aa0a7b6c2025-10-30WarningsExact identifier
rxcui: 309367
unii: G07GZ97H65
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WinCo Foods AntifungalCLOTRIMAZOLEWinco Foods LLCc2ca0787-267a-10f4-e053-2a95a90a3a332025-10-28WarningsExact identifier
rxcui: 309367
unii: G07GZ97H65
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Signature Care Athletes FootCLOTRIMAZOLESafewayc1750c17-4afb-aecf-e053-2a95a90af35b2025-10-22WarningsExact identifier
rxcui: 309367
unii: G07GZ97H65
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fungicure Liquid GelCLOTRIMAZOLEKobayashi Healthcare International, Inc.dfd03852-29bd-4e16-97f3-64dfde5f8ff82025-10-21WarningsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEMarlex Pharmaceuticals Incd6e95c99-e055-436a-8ee6-40d6e199eaca2025-10-08WarningsExact identifier
unii: G07GZ97H65
TM-ClotrimazoleCLOTRIMAZOLE 1%Singular Dreamer, Ltd dba True Markerd6a9755a-9ed1-4e7d-8e73-25c169d6c6b12025-10-06WarningsExact identifier
rxcui: 309367
unii: G07GZ97H65
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
LEADER ATHLETES FOOT CLOTRIMAZOLECLOTRIMAZOLELEADERdcea717b-b097-4a40-8e38-05212731a7ef2025-09-29WarningsExact identifier
rxcui: 309367
unii: G07GZ97H65
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
RUGBY ANTIFUNGAL CLOTRIMAZOLECLOTRIMAZOLERugby Laboratories0b32a369-ea1c-4cb8-8ea1-07bba8f16b722025-09-16WarningsExact identifier
rxcui: 309367
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLESun Pharmaceutical Industries, Inc.77883cfd-f13c-40cb-88b2-8f777e1cdce92025-09-10Warnings, Adverse reactionsExact identifier
application number: ANDA072640
ndc (package): 51672-1275-1
ndc (package): 51672-1275-6
ndc (package): 51672-1275-7
ndc (package): 51672-1275-2
ndc (product): 51672-1275
ndc11 (package): 51672127501
rxcui: 309367
spl id: 3e748b32-1a66-10b0-e063-6394a90a7321
spl set id: 77883cfd-f13c-40cb-88b2-8f777e1cdce9
unii: G07GZ97H65
Clotrimazole and Betamethasone DipropionateCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEBryant Ranch Prepack153fed41-6662-4ca9-802f-84b44dcb65e92025-09-09Warnings, Adverse reactionsExact identifier
unii: G07GZ97H65
ClotrimazoleCLOTRIMAZOLEStrategic Sourcing Services LLCde3b6b64-dfa5-4abd-ba43-4ab59b4c22842025-09-09WarningsExact identifier
unii: G07GZ97H65

Reported adverse events (FAERS/openFDA)#

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