FDA.reportPublic FDA data

NDC 54868-2185-1 - Naftin

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
54868-2185
Requested NDC
54868-2185-1
Package NDCs from labels
54868-2185-2, 54868-2185-1
Manufacturer
Physicians Total Care, Inc.
Effective date
2013-03-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NAFTIN ® NAFTIFINE HCl 1% GELPhysicians Total Care, Inc.2013-03-04HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54868-2185-22019-09-24C16284748780-19350213a-4709-c013-e053-90daa90a1393NAFTIN ® NAFTIFINE HCl 1% GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-2185-2Naftin1 in 1 CARTONGEL12
54868-2185-2Naftin40 g in 1 TUBEGEL402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-2185NAFTIN (NAFTIFINE HYDROCHLORIDE) GEL [PHYSICIANS TOTAL CARE, INC.]22 package rows20130315_c8c13708-b35c-40bf-a911-12e4cffef2a7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54868-2185-1GM - Gram54868-2185f6b90bab-cbd4-425b-bf18-9fbfa3d215a712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAFTIFINE HYDROCHLORIDEACTIVE INGREDIENT25UR9N9041NAFTIN (NAFTIFINE HYDROCHLORIDE) GEL [PHYSICIANS TOTAL CARE, INC.]2
NAFTIFINEACTIVE MOIETY4FB1TON47ANAFTIN (NAFTIFINE HYDROCHLORIDE) GEL [PHYSICIANS TOTAL CARE, INC.]2
CARBOMER 934INACTIVE INGREDIENTZ135WT9208NAFTIN (NAFTIFINE HYDROCHLORIDE) GEL [PHYSICIANS TOTAL CARE, INC.]2
DIISOPROPANOLAMINEINACTIVE INGREDIENT0W44HYL8T5NAFTIN (NAFTIFINE HYDROCHLORIDE) GEL [PHYSICIANS TOTAL CARE, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNAFTIN (NAFTIFINE HYDROCHLORIDE) GEL [PHYSICIANS TOTAL CARE, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNAFTIN (NAFTIFINE HYDROCHLORIDE) GEL [PHYSICIANS TOTAL CARE, INC.]2

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 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: 6OZP39ZG8H
Naftifine HydrochlorideNAFTIFINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.92d3ec30-2176-49cd-8a70-668ef65e76632026-02-12Warnings, Adverse reactionsExact identifier
unii: 25UR9N9041
Naftifine HydrochlorideNAFTIFINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.a740fc0d-45b3-411f-9dfd-f3d637b8a95f2025-11-14Warnings, Adverse reactionsExact identifier
unii: 25UR9N9041
NaftinNAFTIFINE HYDROCHLORIDESebela Pharmaceuticals Inc.6645994a-ecb3-277b-e053-2a91aa0a81e52025-11-08Warnings, Adverse reactionsExact identifier
unii: 25UR9N9041
NaftinNAFTIFINE HYDROCHLORIDELegacy Pharma USA Inc.6c6ee055-4031-45a7-8561-ccd9893435802025-07-30Warnings, Adverse reactionsExact identifier
unii: 25UR9N9041
Naftifine HydrochlorideNAFTIFINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.d50961c2-e97f-4583-91d6-7cafd25a8c3d2025-07-07Warnings, Adverse reactionsExact identifier
unii: 25UR9N9041
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
unii: 6OZP39ZG8H
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
unii: 6OZP39ZG8H
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
unii: 6OZP39ZG8H
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: 6OZP39ZG8H
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: 6OZP39ZG8H
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: 7FLD91C86K
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: 7FLD91C86K
f96d2943-9a0e-47b5-8c05-3d61ded6b051c8c13708-b35c-40bf-a911-12e4cffef2a72013-03-04Warnings, Adverse reactionsExact identifier
spl id: f96d2943-9a0e-47b5-8c05-3d61ded6b051
spl set id: c8c13708-b35c-40bf-a911-12e4cffef2a7

Reported adverse events (FAERS/openFDA)#

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