FDA.reportPublic FDA data

NDC 80610-115-05 - ZORYVE

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
80610-115
Requested NDC
80610-115-05
Package NDCs from labels
80610-115-60, 80610-115-05, 80610-115-96
Manufacturer
Arcutis Biotherapeutics, Inc. | DPT Laboratories, Ltd
Effective date
2026-07-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ZORYVE - Arcutis Biotherapeutics, Inc. | DPT Laboratories, LtdArcutis Biotherapeutics, Inc. | DPT Laboratories, Ltd2026-07-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80610-115-05ZORYVE5 g in 1 TUBECREAM512
80610-115-60ZORYVE1 in 1 CARTONCREAM112
80610-115-60ZORYVE60 g in 1 TUBECREAM6012
80610-115-96ZORYVE6 in 1 CARTONCREAM612

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80610-115ZORYVE (ROFLUMILAST) CREAM [ARCUTIS BIOTHERAPEUTICS, INC.]9Current NDC, 4 package rows20240815_ec1bb0d1-f38a-4080-831a-68791d1d1fdb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80610-115-60GM - Gram80610-115de07469a-dc91-4cd4-ae64-6bd0b3f8eb0512024-08-12

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 16 · 307 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ROFLUMILASTROFLUMILASTAmici Pharma Inc.cb3781ff-5350-4f9a-b247-0b04eb0f2b922026-09-01Warnings, Adverse reactionsExact identifier
unii: 0P6C6ZOP5U
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Supreme Care Protective Zinc CreamPROTECTIVE ZINC CREAMSupreme Products Corporation55f5f098-1732-0fb0-e063-6394a90a708b2026-08-25WarningsExact identifier
unii: B6E5W8RQJ4
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DawnMist White PetrolatumWHITE PETROLATUMDukal LLC598e9d46-6450-af60-e063-6394a90a3a6b2026-08-21WarningsExact identifier
unii: B6E5W8RQJ4
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP0073de92-585d-e01a-e063-6394a90a2ec22026-08-21WarningsExact identifier
unii: B6E5W8RQJ4
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5967ef02-6770-bfd7-e063-6294a90a79042026-08-19WarningsExact identifier
unii: B6E5W8RQJ4
ClaraViePETROLATUMGentell LLC596987e4-4205-b911-e063-6294a90aa5702026-08-19WarningsExact identifier
unii: B6E5W8RQJ4
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5905b300-6f1f-a61f-e063-6394a90a11232026-08-14WarningsExact identifier
unii: B6E5W8RQJ4
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP087d66ff-1a8c-dcb2-e063-6294a90a2f8c2026-08-11WarningsExact identifier
unii: B6E5W8RQJ4
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dealmed Vitamins A and DWHITE PETROLATUMDealmed Medical Supplies, LLC.d6584809-b438-4b2c-ab37-522e0dbef4702026-08-05WarningsExact identifier
unii: B6E5W8RQJ4
VedlubeMINERAL OIL AND WHITE PETROLATUM LUBRICANT EYE OINTMENTVEDCO INC55d126fa-7489-4307-824e-b6957e57d4e92026-07-31WarningsExact identifier
unii: B6E5W8RQJ4
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ZORYVEROFLUMILASTArcutis Biotherapeutics, Inc.ec1bb0d1-f38a-4080-831a-68791d1d1fdb2026-07-20Adverse reactionsExact identifier
application number: NDA215985
ndc (package): 80610-115-60
ndc (package): 80610-105-60
ndc (package): 80610-105-96
ndc (package): 80610-115-96
ndc (package): 80610-105-05
ndc (package): 80610-115-05
ndc (package): 80610-130-05
ndc (package): 80610-130-96
ndc (package): 80610-130-60
ndc (product): 80610-105
ndc (product): 80610-130
ndc (product): 80610-115
ndc11 (package): 80610011505
rxcui: 2687710
rxcui: 2725123
rxcui: 2725121
rxcui: 2687712
rxcui: 2608534
rxcui: 2608539
spl id: 85900c39-1416-4988-b221-d493feae9dca
spl set id: ec1bb0d1-f38a-4080-831a-68791d1d1fdb
unii: 0P6C6ZOP5U
RoflumilastROFLUMILASTJubilant Cadista Pharmaceuticals Inc.aaa81c1b-f63d-4e61-8bfa-9d42d92043c72026-07-14Warnings, Adverse reactionsExact identifier
unii: 0P6C6ZOP5U
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
unii: 2DMT128M1S

Reported adverse events (FAERS/openFDA)#

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