FDA.reportPublic FDA data

MINIDROPS

Product NDC
64108-212
11-digit product format
641080212
Labeler code
64108
Product ID
64108-212_49f38ac7-54c3-3b87-e063-6294a90a65a5
Type
HUMAN OTC DRUG
Nonproprietary name
Lubricant eye drops
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
Optics Laboratory, Inc
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1991-04-01
Substance
POVIDONE, UNSPECIFIED; POLYVINYL ALCOHOL
Active strength
6; 14 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
MINIDROPS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE, UNSPECIFIED6 mg/mL
POLYVINYL ALCOHOL14 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FZ989GH94EInternal UNII lookup
532B59J990Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
359969Internal RxNorm lookup
1046287Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c13c5f91-50df-471c-a7c9-1747a2ac1250Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
64108-212-122021-03-02c13c5f91-50df-471c-a7c9-1747a2ac1250
64108-212-122021-03-02c13c5f91-50df-471c-a7c9-1747a2ac1250
64108-212-132021-03-02c13c5f91-50df-471c-a7c9-1747a2ac1250
64108-212-132021-03-02c13c5f91-50df-471c-a7c9-1747a2ac1250
64108-212-652021-03-02c13c5f91-50df-471c-a7c9-1747a2ac1250
64108-212-652021-03-02c13c5f91-50df-471c-a7c9-1747a2ac1250
64108-212-122021-01-29c13c5f91-50df-471c-a7c9-1747a2ac1250
64108-212-122021-01-29c13c5f91-50df-471c-a7c9-1747a2ac1250
64108-212-132021-01-29c13c5f91-50df-471c-a7c9-1747a2ac1250
64108-212-132021-01-29c13c5f91-50df-471c-a7c9-1747a2ac1250
64108-212-652021-01-29c13c5f91-50df-471c-a7c9-1747a2ac1250
64108-212-652021-01-29c13c5f91-50df-471c-a7c9-1747a2ac1250

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64108-212-10MINIDROPS0.5 mL in 1 VIAL, SINGLE-USELIQUID0.59
64108-212-12MINIDROPS30 in 1 BOXLIQUID309
64108-212-13MINIDROPS5 in 1 BOXLIQUID59
64108-212-65MINIDROPS65 in 1 BOXLIQUID659

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64108-212-12EA - Each64108-21202c2830e-4730-414a-956e-31121c823bca12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYVINYL ALCOHOLACTIVE INGREDIENT532B59J990MINIDROPS (LUBRICANT EYE DROPS) LIQUID [OPTICS LABORATORY, INC]2
POVIDONE K30ACTIVE INGREDIENTU725QWY32XMINIDROPS (LUBRICANT EYE DROPS) LIQUID [OPTICS LABORATORY, INC]2
POLYVINYL ALCOHOLACTIVE MOIETY532B59J990MINIDROPS (LUBRICANT EYE DROPS) LIQUID [OPTICS LABORATORY, INC]2
POVIDONE K30ACTIVE MOIETYU725QWY32XMINIDROPS (LUBRICANT EYE DROPS) LIQUID [OPTICS LABORATORY, INC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMINIDROPS (LUBRICANT EYE DROPS) LIQUID [OPTICS LABORATORY, INC]2
WATERINACTIVE INGREDIENT059QF0KO0RMINIDROPS (LUBRICANT EYE DROPS) LIQUID [OPTICS LABORATORY, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64108-212MINIDROPS (LUBRICANT EYE DROPS) LIQUID [OPTICS LABORATORY, INC]7Current NDC, Legacy NDC, 4 package rows20241218_c13c5f91-50df-471c-a7c9-1747a2ac1250.zip

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 8 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EYE DROPSCARBOXYMETHYLCELLULOSE SODIUMFoshan Sugar Max Cosmetics CO.,Ltd26dbf100-593e-3778-e063-6394a90adf262025-12-30WarningsExact identifier
application number: M018
GoodSense Eye Drops Original FormulaTETRAHYDROZOLINE HCLGeiss, Destin & Dunn, Inc.9b44de58-6362-3811-e053-2995a90a2f372025-12-30WarningsExact identifier
application number: M018
GoodSense Redness Relief PlusGLLYCERIN, NAPHAZOLINE HYDROCHLORIDEGeiss, Destin & Dunn, Inc.9b37250f-9bdf-574e-e053-2a95a90a013e2025-12-30WarningsExact identifier
application number: M018
CVS Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDECVS Pharmacy, Inc.f74a2fca-902c-f68a-e053-6394a90abb882025-12-30WarningsExact identifier
application number: M018
GoodSense Eye Drops Irritation ReliefTETRAHYDROZOLINE HCL, ZINC SULFATEGeiss, Destin & Dunn, Inc.9b24fbdd-780c-1ba2-e053-2a95a90ad60f2025-12-30WarningsExact identifier
application number: M018
CVS Hydration Eye DropsPOLYETYLENE GLYCOL 400, PROPYLENE GLYCOLCVSecab8fa3-6575-0dde-e053-2a95a90abd612025-12-30WarningsExact identifier
application number: M018
Good Sense Artificial TearsPOLYVINYL ALCOHOL, POVIDONEGeiss, Destin & Dunn, Inc.9b243301-2e4b-5706-e053-2995a90a9b902025-12-30WarningsExact identifier
application number: M018
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLGeiss, Derstin & Dunn, Inc.9b34de99-13df-201a-e053-2a95a90ae5592025-12-30WarningsExact identifier
application number: M018
Good Sense Lubricating Plus Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMGoodSenseffd6428e-3bf5-8742-e053-6394a90a4c8f2025-12-30WarningsExact identifier
application number: M018
GoodSense Ultra Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLGeiss, Destin & Dunn, Inc.9b45ebb5-c43b-c9fb-e053-2a95a90a34112025-12-30WarningsExact identifier
application number: M018
CVS Maximum Redness ReliefGLYCERIN, NAPHAZOLINE HCICVS Pharmacy, Inc.f70f9fc4-4022-336e-e053-6394a90a4d072025-12-30WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEDiscount Drug Mart, Inc.f75c2f84-a28c-5807-e053-6294a90a22952025-12-30WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Discount Drug Martf7fd53be-e501-d97f-e053-6394a90ad4092025-12-30WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops A.C.TETRAHYDROZOLINE HCL, ZINC SULFATEDiscount Drug Martf5f1d3da-5300-8211-e053-2a95a90a323a2025-12-30WarningsExact identifier
application number: M018
Exchange Select Eye Drops Advanced Relief MoisturizerDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLArmy and Air Force Exchange Service9e475240-2df1-9bee-e053-2995a90a8d4b2025-12-30WarningsExact identifier
application number: M018
Family Wellness Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLFamily Dollar Services, Inc.facd53c4-9cfc-6589-e053-6394a90a180d2025-12-30WarningsExact identifier
application number: M018
Exchange Select Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Army and Air Force Exchange Service9e478343-8ae7-823e-e053-2995a90a84ed2025-12-30WarningsExact identifier
application number: M018
Family Wellness Advanced Redness Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCLFamily Dollar Services, Inc.fabec215-a040-3f4e-e053-6394a90ad45f2025-12-30WarningsExact identifier
application number: M018
Family Wellness Original Redness Relief Eye DropsTETRAHYDROZOLINE HCLFamily Dollar Services, Inc.fabf540a-8d5c-bb1c-e053-6394a90a75c22025-12-30WarningsExact identifier
application number: M018
Family Wellness Artificial TearsPOLYVINYL ALCOHOL, POVIDONEFamily Dollar Services, Inc.facd329b-1923-61df-e053-6294a90ab7382025-12-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046287MiniDrops 1.4 % / 0.6 % Ophthalmic SolutionPSNc13c5f91-50df-471c-a7c9-1747a2ac12509
359969polyvinyl alcohol 1.4 % / povidone 0.6 % Ophthalmic SolutionPSNc13c5f91-50df-471c-a7c9-1747a2ac12509
1046287polyvinyl alcohol 0.014 ML/ML / povidone 6 MG/ML Ophthalmic Solution [MiniDrops]SBDc13c5f91-50df-471c-a7c9-1747a2ac12509
359969polyvinyl alcohol 0.014 ML/ML / povidone 6 MG/ML Ophthalmic SolutionSCDc13c5f91-50df-471c-a7c9-1747a2ac12509
1046287MiniDrops (polyvinyl alcohol 1.4 % / povidone 0.6 % ) Ophthalmic SolutionSYc13c5f91-50df-471c-a7c9-1747a2ac12509
359969polyvinyl alcohol 1.4 % / povidone 0.6 % Ophthalmic SolutionSYc13c5f91-50df-471c-a7c9-1747a2ac12509

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64108-212-1064108021210.5 mL in 1 VIAL, SINGLE-USE (64108-212-10) 1991-04-01NoNoCurrent
64108-212-126410802121230 VIAL, SINGLE-USE in 1 BOX (64108-212-12) / .5 mL in 1 VIAL, SINGLE-USE (64108-212-10) 1991-04-010000-00-00NoNoCurrent
64108-212-13641080212135 VIAL, SINGLE-USE in 1 BOX (64108-212-13) / .5 mL in 1 VIAL, SINGLE-USE (64108-212-10) 1991-04-010000-00-00NoNoCurrent
64108-212-656410802126565 VIAL, SINGLE-USE in 1 BOX (64108-212-65) / .5 mL in 1 VIAL, SINGLE-USE (64108-212-10) 1991-04-010000-00-00NoNoCurrent