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 4 of 17 · 337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral OilMINERAL OILPerrigo Direct, Incf1656280-fad9-4922-9d5c-be774a8b14222026-02-19Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILMeijer, Inc.652d1da9-a71f-4113-9ef3-da09167246252026-02-19Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILTarget Corporation526508f0-e908-4e3d-88f5-404a95f6de762026-02-18Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILUnited Natural Foods, Inc. dba UNFIcb7bc571-295f-47c2-ae93-18cba194752c2026-02-17Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILStrategic Sourcing Services LLCe4965086-dcc0-4b34-bb30-81facf7139f32026-02-17Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILTopco Associates LLCe9b1fd61-c229-4529-82c2-d6ac5b0760822026-02-13WarningsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILWalgreen Co.822fd02a-92b0-4010-8bfb-737dba331d542026-02-12Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
iShanCare Vaginal Antibacterial GelISHANCARE VAGINAL ANTIBACTERIAL GELShenzhen Ishan Technology Co., Ltd254a6624-80b6-b089-e063-6294a90a887e2026-02-12WarningsExact identifier
unii: 33X04XA5AT
Mineral OilMINERAL OILRetail Business Services, LLCb0abcdf9-c226-424f-8970-c2135708c6c82026-02-06Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Signature Care HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCIBetter Living Brands, LLC3c8b43f3-6e1e-499e-ba71-ffdf836f67432026-02-05WarningsExact identifier
unii: T5L8T28FGP
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.1cada0ae-3f0f-441c-a633-faa0a3009d2b2026-02-05WarningsExact identifier
unii: T5L8T28FGP
Harris TeeterMINERALHarris Teeter401e3a7e-54be-47cc-88c3-a343f5cbbd102026-02-04Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLSportpharm LLC88e3624d-b8bb-4e65-9250-4c51d2bbed162026-02-03WarningsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILCARDINAL HEALTH 110, LLC. DBA LEADER803f444f-d136-4f06-9842-24a71a3d7d6b2026-01-29Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
careone hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLAmerican Sales Company46794d2e-8fe6-490d-9cfa-ba9b6c209ad62026-01-29WarningsExact identifier
unii: T5L8T28FGP
foster and thrive hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLStrategic Sourcing Services LLC9da843f2-e88c-432e-b091-a6acf81d856b2026-01-22WarningsExact identifier
unii: T5L8T28FGP
Ciclopirox OlamineCICLOPIROX OLAMINEGlenmark Pharmaceuticals Inc., USA7385cf42-9f80-4542-8e0f-a0228aa9b43a2026-01-22Warnings, Adverse reactionsExact identifier
rxcui: 309289
unii: 50MD4SB4AP
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ciclopirox OlamineCICLOPIROX OLAMINESun Pharmaceutical Industries, Inc.7fa4032e-a819-4574-b484-c57aaf1c5b012026-01-16Warnings, Adverse reactionsExact identifier
application number: ANDA076790
ndc (package): 51672-1318-1
ndc (package): 51672-1318-8
ndc (package): 51672-1318-2
ndc (product): 51672-1318
ndc11 (package): 51672131801
rxcui: 309289
spl id: 4882ff99-b917-693b-e063-6394a90a4476
spl set id: 7fa4032e-a819-4574-b484-c57aaf1c5b01
unii: 50MD4SB4AP
retaine PMMINERAL OIL, WHITE PETROLATUMOCuSOFT LLCac75e5c9-94ae-698d-40da-dffe4458a0982026-01-15WarningsExact identifier
unii: T5L8T28FGP

Reported adverse events (FAERS/openFDA)#

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