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 9 of 17 · 337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Mineral OilMINERAL OILATLANTIC BIOLOGICALS CORP.960502ae-2468-406e-8799-cacb01f2727e2025-05-23WarningsExact identifier
unii: T5L8T28FGP
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Mineral OilMINERAL OILAmerisourceBergen (Good Neighbor Pharmacy) 46122581f81a0-7488-4c90-b33e-06c6301a4fd22025-04-17WarningsExact identifier
unii: T5L8T28FGP
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLBionpharma Inc.1790da99-2a22-e2a2-e063-6394a90ac36f2025-03-31WarningsExact identifier
unii: T5L8T28FGP
Dr. Butler Hemorrhoid and PerinealMINERAL OIL 59.8%,PETROLATUM 36%Beyond Health P.A.d17b6f16-6893-ce0a-e053-2a95a90aa23a2025-03-19WarningsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILKesin Pharma Corporation30a11cc9-e407-23b7-e063-6294a90a7d6e2025-03-18WarningsExact identifier
unii: T5L8T28FGP
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
Medicated Foaming FeminineLACTIC ACID, BORIC ACID, CHLORHEXIDINE GLUCONATE, CNIDIUM MONNIERI FRUIT, LEVOMENOLRida LLC02b3d683-05b0-4075-bbf9-e6d97c61765c2025-03-06WarningsExact identifier
unii: 33X04XA5AT
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Mineral oilMINERAL OILP & L Development, LLC68e88119-1468-4ab7-a5fa-242d960d25df2025-02-21WarningsExact identifier
unii: T5L8T28FGP
FEELSHION Glycolic Acid Exfoliating Face PadsPROPYLENE GLYCOL,ARGININE,LACTIC ACID,SALICYLIC ACID,GLYCOLIC ACIDBeijing JUNGE Technology Co., Ltd.2e79678c-1ce4-25cf-e063-6394a90a133c2025-02-19WarningsExact identifier
unii: 33X04XA5AT
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Mineral oilMINERAL OILBest Choice (Valu Merchandisers Company)3ec8a716-60e0-4dfb-adae-ddc53c6139352025-02-04WarningsExact identifier
unii: T5L8T28FGP
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Ciclopirox OlamineCICLOPIROX OLAMINEBryant Ranch Prepack29c638cd-b6cb-4e17-8cb3-636253a2e47c2025-01-28Warnings, Adverse reactionsExact identifier
unii: 50MD4SB4AP
HemorrhoidalPAIN RELIEFNeilMed Pharmaceuticals Inc.038a2cf5-1b72-227b-e063-6394a90a84ad2025-01-24WarningsExact identifier
unii: T5L8T28FGP
Ciclopirox OlamineCICLOPIROX OLAMINEBryant Ranch Prepack246585a0-e53e-4f54-8f8b-76536011ab232025-01-24Warnings, Adverse reactionsExact identifier
unii: 50MD4SB4AP

Reported adverse events (FAERS/openFDA)#

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