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 18 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OASIS Tears Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.d9d71b1d-82a6-42e7-9ef2-2d041daef9362024-12-23WarningsExact identifier
application number: M018
Ancient Secrets Breathe AgainSODIUM CHLORIDELOTUS BRANDS, INC.c6d2bab0-d363-4c09-a71b-ae15db915b372024-12-18WarningsExact identifier
application number: M018
TheraTears ExtraCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMMEDTECH PRODUCTS INC77f504c1-b8e0-4371-ac3e-9d453d84714b2024-12-13WarningsExact identifier
application number: M018
TheraTears ExtraCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDMEDTECH PRODUCTS INCf1845041-9d8d-42a0-a2cb-68def7a5aac72024-12-13WarningsExact identifier
application number: M018
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
application number: M018
Systane NighttimeMINERAL OIL AND WHITE PETROLATUMAlcon Laboratories, Inc.4689c59c-5721-3f91-6c85-e41501998fd02024-12-05WarningsExact identifier
application number: M018
GenTeal Tears NIGHT-TIMEMINERAL OIL, WHITE PETROLATUMAlcon Laboratories, Inc.9d5998a7-4f59-4293-87da-8419650a524d2024-12-05WarningsExact identifier
application number: M018
Visine Red Eye Total Comfort and Tears Dry Eye ReliefTETRAHYDROZOLINE HCL, POLYETHYLENE GLYCOL 400, ZINC SULFATEKenvue Brands LLC0bc0d6e7-9195-db6b-e063-6294a90aef042024-11-14WarningsExact identifier
application number: M018
Visine Red Eye ComfortTETRAHYDROZOLINE HYDROCHLORIDEKenvue Brands LLCd7abd7cb-e094-481f-bea5-a5983e2c9ef42024-11-13WarningsExact identifier
application number: M018
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Kenvue Brands LLCa9a90de6-3172-4d34-984b-f4442f880e3d2024-11-13WarningsExact identifier
application number: M018
Visine Dry Eye ReliefPOLYETHYLENE GLYCOL 400Kenvue Brands LLC2de7a41d-661d-495f-89b4-5690664a3a3d2024-11-13WarningsExact identifier
application number: M018
Visine Dry Eye Relief Eye DropsPOLYETHYLENE GLYCOL 400Kenvue Brands LLCd9d3f000-3ce4-4ba2-a7fb-491b44eb3fa12024-11-13WarningsExact identifier
application number: M018
Visine Dry Eye ReliefPOLYETHYLENE GLYCOL 400Kenvue Brands LLCa4c57620-778f-4434-9105-ead2f85c58842024-11-13WarningsExact identifier
application number: M018
Visine A.C. Itchy Eye ReliefTETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE, UNSPECIFIED FORMKenvue Brands LLC257b9666-0163-499b-9673-bf6f4d6899b12024-11-13WarningsExact identifier
application number: M018
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLAcme United Corporationf19fbe28-b928-7c6e-e053-2995a90a43cb2024-11-09WarningsExact identifier
application number: M018
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
application number: M018
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
application number: M018
Clear Eyes Cooling Redness ReliefGLYCERIN AND NAPHAZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.38d14e99-e4c8-431b-b106-578eeb38bf3c2024-10-25WarningsExact identifier
application number: M018
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
application number: M018
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact 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