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 5 of 17 · 337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WalgreensHEMORRHOIDAL PAIN RELIEFWalgreensb0b1ce47-9fa4-4505-8f38-39a0d500e9f62026-01-15WarningsExact identifier
unii: T5L8T28FGP
Helocaine Cold Sore Fever Blister TreatmentTETRACAINE, MINERALPagari Life Science Corp.1b2eae09-5de0-9219-e063-6294a90af0462026-01-15WarningsExact identifier
unii: T5L8T28FGP
retaine MGDMINERAL OILOCuSOFT LLC06f57d46-96c7-4093-84aa-874ff4b2131d2026-01-15WarningsExact identifier
unii: T5L8T28FGP
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDEUniversal Distribution Center LLC90844919-f16a-4390-9dca-b0405b5014452026-01-08WarningsExact identifier
unii: T5L8T28FGP
Foster and Thrive Ready to Use Mineral oil LaxativeMINERAL OILStrategic Sourcing Services LLCea6da66c-6825-4cd7-8791-45b537bf203a2026-01-08WarningsExact identifier
unii: T5L8T28FGP
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
HealthMart Mineral Oil Single LaxativeMINERAL OILStrategic Sourcing Services LLC1238ec69-1ea3-4773-9f13-71f0ae0a35532026-01-08WarningsExact identifier
unii: T5L8T28FGP
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDESafeway3e6728b6-26e3-4287-8ba6-e27f305cd93b2025-12-20WarningsExact identifier
unii: T5L8T28FGP
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
unii: 2KR89I4H1Y
Category VIMMUNE SYSTEM BOOSTERVitality Works, Inc,0d3dd923-336c-4ccd-a344-ec49b2e80d102025-12-17WarningsExact identifier
unii: 33X04XA5AT

Reported adverse events (FAERS/openFDA)#

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