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#

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#

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 20 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clear Eyes Natural TearsPOLYVINYL ALCOHOL AND POVIDONEPrestige Brands Holdings, Inc.efba3eb0-798d-4635-b19b-4970e45b3cc92024-04-01WarningsExact identifier
application number: M018
Polyvinyl AlcoholPOLYVINYL ALCOHOLA-S Medication Solutionsc77589fd-f68d-48b7-bd12-51f6b4cc94022024-03-20WarningsExact identifier
application number: M018
REFRESH CLASSICPOLYVINYL ALCOHOL, POVIDONEA-S Medication Solutions3bf6193c-56db-45ad-844c-58eb8c33cba92024-03-14WarningsExact identifier
application number: M018
GOODSENSE ARTIFICIAL TEARSPOLYVINYL ALCOHOLProficient Rx LPf29c792c-6cb2-449f-b97d-6304a58dec2a2024-02-01WarningsExact identifier
application number: M018
GoodSense Artifical TearsPOLYVINYL ALCOHOL, AND POVIDONEProficient Rx LPcd24da78-fd90-4a9c-8e5f-f7fc56ec0fc92024-02-01WarningsExact identifier
application number: M018
GENTEAL TEARSDEXTRAN 70, GLYCERIN, HYPROMELLOSEA-S Medication Solutionsa2b715e9-332d-4f0b-b8e5-ebc0006815862024-01-21WarningsExact identifier
application number: M018
Visine Red Eye Hydrating Comfort, CVPTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400 SOLUTION/ DROPSLil' Drug Store Products, Inc.0f50bcc8-3658-8c2c-e063-6294a90a8e132024-01-19WarningsExact identifier
application number: M018
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.b56ef662-fec2-4d94-e053-2995a90aba2b2024-01-06WarningsExact identifier
application number: M018
Exchange Select Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLArmy and Air Force Exchange Service318bc025-c936-a066-e063-6294a90a47122024-01-01WarningsExact identifier
application number: M018
Kroger Eye Drops OriginalTETRAHYDROZOLINE HCLThe Kroger Co.318c17a1-fe08-508b-e063-6394a90a2e082024-01-01WarningsExact identifier
application number: M018
HEB Original Eye DropsTETRAHYDROZOLINE HCLHEB Grocery Company, LP318cb457-bb2d-a1ee-e063-6294a90a80192024-01-01WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops Multi-Symptom ReliefPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEDiscount Drug Mart, Inc.318dc92a-0707-d6a4-e063-6294a90ab78a2024-01-01WarningsExact identifier
application number: M018
Kroger Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEThe Kroger Co.318dea21-2656-36a3-e063-6294a90ac9c42024-01-01WarningsExact identifier
application number: M018
Harris Teeter Eye Drops OriginalTETRAHYDROZOLINE HCLHarris Teeter, LLC.P31a1b962-27ad-97b1-e063-6294a90a77f12024-01-01WarningsExact identifier
application number: M018
CVP Sterile Eye DropsTETRAHYDROZOLINE HCLSalado Sales, Inc.31a216f8-28e9-ec8f-e063-6394a90aec492024-01-01WarningsExact identifier
application number: M018
Equaline Sterile Eye DropsTETRAHYDROZOLINE HCLUnited Natural Foods, Inc.31a25efb-a627-1a13-e063-6394a90a2ca32024-01-01WarningsExact identifier
application number: M018
Best Choice Eye Drops OriginalTETRAHYDROZOLINE HCLValu Merchandisers Company31a2a42a-bcfe-4f22-e063-6294a90ac60e2024-01-01WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops OriginalTETRAHYDROZOLINE HCLDiscount Drug Mart, Inc.31a2efb2-3924-6a12-e063-6394a90ab0e22024-01-01WarningsExact identifier
application number: M018
Equaline Redness Relief Lubricant Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEUnited Natural Foods, Inc31a30b00-9f4b-717a-e063-6394a90a8a872024-01-01WarningsExact identifier
application number: M018
Harris Teeter Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEHarris Teeter, LLC.31a3d575-10f1-5feb-e063-6294a90ac4782024-01-01WarningsExact 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