FDA.reportPublic FDA data

NDC 0061-1088-01 - Optimmune Ophthalmic

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
0061-1088
Requested NDC
0061-1088-01
Package NDCs from labels
0061-1088-01
Manufacturer
Merck Sharp & Dohme Corp.
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
Optimmune ® (0.2% Cyclosporine, USP) Ophthalmic OintmentMerck Sharp & Dohme Corp.2026-01-16PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0061-1088-01Optimmune Ophthalmic3.5 g in 1 TUBEOINTMENT3.510
0061-1088-01Optimmune Ophthalmic1 in 1 CARTONOINTMENT110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0061-1088OPTIMMUNE OPHTHALMIC (CYCLOSPORINE) OINTMENT [MERCK SHARP & DOHME CORP.]82 package rows20241120_8ee9c677-d86c-4f2f-9eec-6998f4394ae1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CyclosporineACTIVE INGREDIENT83HN0GTJ6DOPTIMMUNE (CYCLOSPORINE) OINTMENT [SCHERING CORPORATION]2
CyclosporineACTIVE MOIETY83HN0GTJ6DOPTIMMUNE (CYCLOSPORINE) OINTMENT [SCHERING CORPORATION]2
Corn OilINACTIVE INGREDIENT8470G57WFMOPTIMMUNE (CYCLOSPORINE) OINTMENT [SCHERING CORPORATION]2
Lanolin AlcoholsINACTIVE INGREDIENT884C3FA9HEOPTIMMUNE (CYCLOSPORINE) OINTMENT [SCHERING CORPORATION]2
ParaffinINACTIVE INGREDIENTI9O0E3H2ZEOPTIMMUNE (CYCLOSPORINE) OINTMENT [SCHERING CORPORATION]2
PetrolatumINACTIVE INGREDIENT4T6H12BN9UOPTIMMUNE (CYCLOSPORINE) OINTMENT [SCHERING CORPORATION]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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CycloSPORINE, ModfiedCYCLOSPORINEApotex Corp.5baaf78c-90f6-abcf-52c8-814490f3cf9f2026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
CyclosporineCYCLOSPORINEStrides Pharma Science Limitedc36132b2-3ec7-4c43-a25e-75cbdbe3d88d2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
NeoralCYCLOSPORINENovartis Pharmaceuticals Corporation94461af3-11f1-4670-95d4-2965b9538ae32026-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
SandimmuneCYCLOSPORINENovartis Pharmaceuticals Corporation5e5926a7-1de0-4b54-a5c0-286b6200ff822026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
CEQUACYCLOSPORINESun Pharmaceutical Industries, Inc.48c3d8a3-4289-4b52-9189-58b48596095c2026-06-15Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
VerkaziaCYCLOSPORINEHarrow Eye, LLC48651d30-9e6e-74b0-e063-6294a90a83372026-06-03Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
CYCLOSPORINECYCLOSPORINEUpsher-Smith Laboratories, LLCf7e4a2f0-ea2a-449b-bc6d-a6ea3d47b8502026-05-22Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
CyclosporineCYCLOSPORINEApotex Corp.bfca7088-fe93-abb9-3ec3-e6f5710a69c62026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
VEVYECYCLOSPORINE OPHTHALMIC SOLUTIONHarrow Eye, LLC0a60fccf-7e1b-44fe-e063-6394a90aadd52026-02-26Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
CYCLOSPORINECYCLOSPORINESaptalis Pharmaceuticals, LLCff4dc2fc-667a-489a-b798-8d11cddfe7162025-12-09Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
CYCLOSPORINECYCLOSPORINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1952d4c7-a40e-4924-b669-c41400774cb92025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
Restasis MultiDoseCYCLOSPORINEAllergan, Inc.7224d810-bb96-4682-a942-3355e6e8061a2025-08-21Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
CyclosporineCYCLOSPORINEDevatis Inc.7bb2078d-17c2-4e6a-9f61-26c7ecbce9452025-02-17Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
VerkaziaCYCLOSPORINESanten Incorporatedc795cd2f-89da-78e3-e053-2a95a90a94222025-01-17Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
CyclosporineCYCLOSPORINEApotex Corp70c8a4a6-ebe2-457f-a626-400c338cec2d2024-09-23Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
CyclosporineCYCLOSPORINEKVK-TECH, INC.a7040dc6-063b-40ee-8f2a-153e87b084302024-09-23Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
RESTASISCYCLOSPORINEAllergan, Inc.8e24af2b-bc1c-4849-94f2-6df950cdca892024-09-09Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
CYCLOSPORINECYCLOSPORINELupin Pharmaceuticals, Inc.9aca2026-af86-4e97-925e-c202b87c46ac2024-09-01Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
GengrafCYCLOSPORINEAbbVie Inc.e896cbfe-4745-4088-82a3-8dc10b75c41f2024-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D
CyclosporineCYCLOSPORINETeva Pharmaceuticals USA, Inc.f3dc2a50-1084-4190-a6f3-37034a04db862024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 83HN0GTJ6D

Reported adverse events (FAERS/openFDA)#

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