FDA.reportPublic FDA data

NDC 80425-0225-01 - 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
80425-0225
Requested NDC
80425-0225-01
Package NDCs from labels
80425-0225-1, 80425-0225-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ciclopirox Olamine - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0225-1Ciclopirox Olamine30 g in 1 CARTONCREAM303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0225CICLOPIROX OLAMINE CREAM [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, Legacy NDC, 1 package rows20250102_f186e394-7390-4b8a-e053-2a95a90abed1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0225-1GM - Gram80425-0225b2d4d77c-2425-46f2-ba61-83dfa28a705512023-03-13

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 ยท 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ciclopirox OlamineCICLOPIROX OLAMINEBryant Ranch Prepack6d02fb24-9736-4fe3-b909-1b2172aa27732026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 309289
unii: 50MD4SB4AP
Ciclopirox olamineCICLOPIROX OLAMINEBryant Ranch Prepack74fda3b8-d1f0-4ade-a92a-286f3874f2922026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 309289
unii: 50MD4SB4AP
Ciclopirox OlamineCICLOPIROX OLAMINEBryant Ranch Prepackaa326ade-ff55-4355-b6c7-205d6d88d0a32026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 309289
unii: 50MD4SB4AP
Ciclopirox olamineCICLOPIROX OLAMINEPadagis Israel Pharmaceuticals Ltd1a74ed86-997a-4b86-b54a-b2b2c94e8abb2026-04-20Warnings, Adverse reactionsExact identifier
rxcui: 309289
unii: 50MD4SB4AP
Ciclopirox OlamineCICLOPIROX OLAMINEPadagis Israel Pharmaceuticals Ltdeadbd29d-5990-4987-833f-40cd0b2d28682026-04-16Warnings, Adverse reactionsExact identifier
unii: 50MD4SB4AP
Ciclopirox OlamineCICLOPIROX OLAMINEGlenmark Pharmaceuticals Inc., USA7385cf42-9f80-4542-8e0f-a0228aa9b43a2026-01-22Warnings, Adverse reactionsExact identifier
application number: ANDA090273
ndc (product): 68462-297
rxcui: 309289
spl id: 740c1d91-06c1-4508-9e94-e5308bec9be3
spl set id: 7385cf42-9f80-4542-8e0f-a0228aa9b43a
unii: 50MD4SB4AP
Ciclopirox OlamineCICLOPIROX OLAMINESun Pharmaceutical Industries, Inc.7fa4032e-a819-4574-b484-c57aaf1c5b012026-01-16Warnings, Adverse reactionsExact identifier
rxcui: 309289
unii: 50MD4SB4AP
Ciclopirox OlamineCICLOPIROX OLAMINEBryant Ranch Prepack835a6370-f331-4b15-b6fa-beafe027f1872025-10-24Warnings, Adverse reactionsExact identifier
unii: 50MD4SB4AP
Ciclopirox olamineCICLOPIROX OLAMINEBryant Ranch Prepack43a7cab8-7921-43bd-8bfa-a9b96f97c94b2025-10-24Warnings, Adverse reactionsExact identifier
rxcui: 309289
unii: 50MD4SB4AP
Ciclopirox OlamineCICLOPIROX OLAMINEBryant Ranch Prepack81e31568-6d87-4d0b-ba52-d2794a7cb0232025-10-07Warnings, Adverse reactionsExact identifier
rxcui: 309289
unii: 50MD4SB4AP
Ciclopirox OlamineCICLOPIROX OLAMINEBryant Ranch Prepack9130e3c7-566b-411b-b54d-c894e9094b5b2025-07-28Warnings, Adverse reactionsExact identifier
unii: 50MD4SB4AP
Ciclopirox OlamineCICLOPIROX OLAMINEBryant Ranch Prepack29c638cd-b6cb-4e17-8cb3-636253a2e47c2025-01-28Warnings, Adverse reactionsExact identifier
unii: 50MD4SB4AP
Ciclopirox OlamineCICLOPIROX OLAMINEBryant Ranch Prepack246585a0-e53e-4f54-8f8b-76536011ab232025-01-24Warnings, Adverse reactionsExact identifier
unii: 50MD4SB4AP
Ciclopirox OlamineCICLOPIROX OLAMINEAdvanced Rx Pharmacy of Tennessee, LLCf186e394-7390-4b8a-e053-2a95a90abed12024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA090273
ndc (package): 80425-0225-1
ndc (product): 80425-0225
ndc11 (package): 80425022501
rxcui: 309289
spl id: 2a9b7c00-167c-4da0-e063-6394a90a926d
spl set id: f186e394-7390-4b8a-e053-2a95a90abed1
unii: 50MD4SB4AP
Ciclopirox OlamineCICLOPIROX OLAMINEBryant Ranch Prepack399fd2d5-f5a2-4bce-ad4e-ce70060a14b02024-12-24Warnings, Adverse reactionsExact identifier
unii: 50MD4SB4AP
Ciclopirox OlamineCICLOPIROX OLAMINECosette Pharmaceuticals, Inc.5c585aa5-7d2d-e798-c0bd-d602574d643c2022-11-16Warnings, Adverse reactionsExact identifier
rxcui: 309289
unii: 50MD4SB4AP

Reported adverse events (FAERS/openFDA)#

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