FDA.reportPublic FDA data

NDC 65862-947-15 - Dorzolamide Hydrochloride and Timolol Maleate Preservative Free

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
65862-947
Requested NDC
65862-947-15
Package NDCs from labels
65862-947-15, 65862-947-60, 65862-947-18
Manufacturer
Aurobindo Pharma Limited | EUGIA PHARMA SPECIALITIES LIMITED
Effective date
2026-08-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DORZOLAMIDE - Aurobindo Pharma Limited | EUGIA PHARMA SPECIALITIES LIMITEDAurobindo Pharma Limited | EUGIA PHARMA SPECIALITIES LIMITED2026-08-13Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-947-15Dorzolamide Hydrochloride and Timolol Maleate Preservative Free0.2 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.23
65862-947-15Dorzolamide Hydrochloride and Timolol Maleate Preservative Free15 in 1 POUCHSOLUTION/ DROPS153
65862-947-18Dorzolamide Hydrochloride and Timolol Maleate Preservative Free15 in 1 POUCHSOLUTION/ DROPS153
65862-947-18Dorzolamide Hydrochloride and Timolol Maleate Preservative Free12 in 1 CARTONSOLUTION/ DROPS123
65862-947-60Dorzolamide Hydrochloride and Timolol Maleate Preservative Free4 in 1 CARTONSOLUTION/ DROPS43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-947DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE SOLUTION/ DROPS [AUROBINDO PHARMA LIMITED]2Current NDC, Legacy NDC, 5 package rows20230823_f41a9cd5-48c8-42eb-bb1b-d0355d981201.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-947-15EA - Each65862-947d3c2fd4a-4d96-4df7-ad3b-c264049d821312018-08-13
65862-947-60EA - Each65862-9479d0f3b10-f1ea-4cb4-89fc-2a69c697658512018-08-13

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 4 of 15 · 300 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
Timolol MaleateTIMOLOL MALEATEA-S Medication Solutions7a1ea848-5b55-4038-afb1-029645ee09252025-12-30Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAEDDORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATEIndoco Remedies Limited0b75a79a-e048-4bf1-b02b-a72a8b8a0b3b2025-12-22Warnings, Adverse reactionsExact identifier
unii: QZO5366EW7
unii: P8Y54F701R
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TIMOLOL MALEATETIMOLOL MALEATERising Pharma Holdings, Inc.2ed21930-1e05-46de-8acd-cb6f4798a7fa2025-12-15Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
Timolol maleateTIMOLOL MALEATEArmas Pharmaceuticals, Inc.ea585fe8-3356-4f08-8078-34e8ab5de37e2025-12-03Warnings, Adverse reactionsExact identifier
unii: P8Y54F701R
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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