FDA.reportPublic FDA data

NDC 51672-1318-01 - Ciclopirox Olamine

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
51672-1318
Requested NDC
51672-1318-01
Package NDCs from labels
51672-1318-1, 51672-1318-2, 51672-1318-8, 51672-1318-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2026-01-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ciclopirox Olamine Cream USP, 1.0%Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2026-01-16HUMAN PRESCRIPTION DRUG LABEL
Ciclopirox Olamine Cream USP, 0.77%RPK Pharmaceuticals, Inc.2023-06-07HUMAN PRESCRIPTION DRUG LABEL
Ciclopirox Olamine Cream USP, 0.77%NuCare Pharmaceuticals,Inc.2021-02-15HUMAN PRESCRIPTION DRUG LABEL
Ciclopirox Olamine Cream USP, 0.77%Physicians Total Care, Inc.2013-02-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1318-1Ciclopirox Olamine1 in 1 CARTONCREAM19
51672-1318-1Ciclopirox Olamine15 g in 1 TUBECREAM159
51672-1318-2Ciclopirox Olamine30 g in 1 TUBECREAM309
51672-1318-2Ciclopirox Olamine1 in 1 CARTONCREAM19
51672-1318-8Ciclopirox Olamine90 g in 1 TUBECREAM909
51672-1318-8Ciclopirox Olamine1 in 1 CARTONCREAM19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1318CICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 6 package rows20241222_7fa4032e-a819-4574-b484-c57aaf1c5b01.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1318-1GM - Gram51672-131871b79573-2906-4f5a-8f8a-3db7a79e18e512012-07-24
51672-1318-2GM - Gram51672-1318a1a6a8a4-1338-4eec-a5e0-b370deed22f212012-07-24
51672-1318-8GM - Gram51672-13180754035b-bb19-4ce0-9854-ca6ccf2b126612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ciclopirox olamineACTIVE INGREDIENT50MD4SB4APCICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.]3
ciclopirox olamineACTIVE INGREDIENT50MD4SB4APCICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
CiclopiroxACTIVE MOIETY19W019ZDRJCICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.]3
CiclopiroxACTIVE MOIETY19W019ZDRJCICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHCICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.]3
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHCICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
cetyl alcoholINACTIVE INGREDIENT936JST6JCNCICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.]3
cetyl alcoholINACTIVE INGREDIENT936JST6JCNCICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
Coco DiethanolamideINACTIVE INGREDIENT92005F972DCICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
Coco DiethanolamideINACTIVE INGREDIENT92005F972DCICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.]3
lactic acidINACTIVE INGREDIENT33X04XA5ATCICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.]3
lactic acidINACTIVE INGREDIENT33X04XA5ATCICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
mineral oilINACTIVE INGREDIENTT5L8T28FGPCICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
mineral oilINACTIVE INGREDIENTT5L8T28FGPCICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.]3
myristyl alcoholINACTIVE INGREDIENTV42034O9PUCICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
myristyl alcoholINACTIVE INGREDIENTV42034O9PUCICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.]3
octyldodecanolINACTIVE INGREDIENT461N1O614YCICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
octyldodecanolINACTIVE INGREDIENT461N1O614YCICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.]3
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MCICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MCICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.]3
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XCICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XCICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.]3
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YCICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.]3
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YCICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RCICLOPIROX OLAMINE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RCICLOPIROX OLAMINE CREAM [PHYSICIANS TOTAL CARE, INC.]3

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 7 of 17 · 337 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
GNP HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE, HCLAmerisource Bergenb0f0ef97-9add-717f-e053-2a95a90a0eb02025-10-30WarningsExact identifier
unii: T5L8T28FGP
Hemorrhoid AnestheticMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLUniversal Distribution Center LLC186c2d32-e8c5-d13d-e063-6294a90a2b0e2025-10-30WarningsExact identifier
unii: T5L8T28FGP
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ciclopirox OlamineCICLOPIROX OLAMINEBryant Ranch Prepack835a6370-f331-4b15-b6fa-beafe027f1872025-10-24Warnings, Adverse reactionsExact identifier
unii: 50MD4SB4AP
Ciclopirox olamineCICLOPIROX OLAMINEBryant Ranch Prepack43a7cab8-7921-43bd-8bfa-a9b96f97c94b2025-10-24Warnings, Adverse reactionsExact identifier
rxcui: 309289
unii: 50MD4SB4AP
Winco HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEWinco Foods, LLC04ca3ef1-fc6b-4683-b236-a75afc031fb52025-10-23WarningsExact identifier
unii: T5L8T28FGP
Family Care HemorrhoidalMINERAL OILUnited Exchange Corp04375257-f4f3-48c3-a338-de43298b95eb2025-10-22WarningsExact identifier
unii: T5L8T28FGP
Family Wellness HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCLFamily Dollar Services, Incfe3293bc-80b5-b60a-e053-6394a90a4ede2025-10-22WarningsExact identifier
unii: T5L8T28FGP
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ciclopirox OlamineCICLOPIROX OLAMINEBryant Ranch Prepack81e31568-6d87-4d0b-ba52-d2794a7cb0232025-10-07Warnings, Adverse reactionsExact identifier
rxcui: 309289
unii: 50MD4SB4AP
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
Leader Ready to Use Mineral Oil LaxativeMINERAL OILCardinal Healthb8494d02-8a7d-47b4-80b0-b8ab51b625fd2025-09-29WarningsExact identifier
unii: T5L8T28FGP
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
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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