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 8 of 17 · 337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Exchange Select HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLArmy & Air Force Exchange Service6c32af3e-5b60-4e3e-95c2-ada37a7d3b2a2025-08-22WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLPadagis Israel Pharmaceuticals Ltd43826c68-0a20-460d-a7b5-f3e12395a7d02025-08-22WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLPublix Super Markets Inc7b360d3b-fb2b-4f35-a04d-203dd352933d2025-08-19WarningsExact identifier
unii: T5L8T28FGP
Good Sense HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLL. Perrigo Company2492ee1b-01f1-46e7-8790-b6ebc48f2aff2025-08-19WarningsExact identifier
unii: T5L8T28FGP
DG Health HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLDolgencorp, LLCd9f12a34-7bd1-4ba5-b34b-1b641f58271a2025-08-12WarningsExact identifier
unii: T5L8T28FGP
StyeMINERAL OIL AND PETROLATUMInsight Pharmaceuticals LLCf7eb8466-d8ea-4833-9bed-244ead38a3bf2025-08-11WarningsExact identifier
unii: T5L8T28FGP
LEADER Mineral OilMINERAL OILCardinal Health, 110 dba Leader7d4f8fa3-8203-5523-e053-2991aa0aba1a2025-07-28WarningsExact identifier
unii: T5L8T28FGP
Ciclopirox OlamineCICLOPIROX OLAMINEBryant Ranch Prepack9130e3c7-566b-411b-b54d-c894e9094b5b2025-07-28Warnings, Adverse reactionsExact identifier
unii: 50MD4SB4AP
Dr Butlers Soothing IncontinenceMINERAL OIL 59.8%, PETROLATUM 36.0%Beyond Health PA3a9d3796-fd05-fe57-e063-6294a90a0ac62025-07-23WarningsExact identifier
unii: T5L8T28FGP
Eyeleve MGDMINERAL OILBruder Healthcare145b66e2-00e1-410e-8539-e12ffc4f6f822025-07-15WarningsExact identifier
unii: T5L8T28FGP
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
ProCure HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLTwin Med LLC37a4cc43-0d53-f1bf-e063-6394a90a2dc92025-06-15WarningsExact identifier
unii: T5L8T28FGP
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF OINTMENTNeilmed Pharmaceuticals Inc.374d89b6-9305-9adf-e063-6394a90adb322025-06-11WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLC4eb3c9ac-268a-5246-e054-00144ff88e882025-06-09WarningsExact identifier
unii: T5L8T28FGP
PRISMASOL BGK2/0MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDEVantive US Healthcare LLC7f675fee-8940-4ece-bb0c-75ac79d8708c2025-05-31Warnings, Adverse reactionsExact identifier
unii: 33X04XA5AT

Reported adverse events (FAERS/openFDA)#

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