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 23 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLBetter Living Brands LLC5d7228ce-f108-4cc2-9aec-8b4548c3a1552023-12-20WarningsExact identifier
application number: M018
Target Eye Drops Maximum Redness Relief EyeGLYCERIN, NAPHAZOLINE HYDROCHLORIDETarget Corporation1b26cd3b-4a05-4623-b320-01f22b3106ff2023-12-20WarningsExact identifier
application number: M018
Kroger High Performance Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLKrogerd2aa8963-1922-02f3-e053-2a95a90a7d932023-12-20WarningsExact identifier
application number: M018
Kroger Eye Drops Seasonal ReliefTETRAHYDROZOLINE HCL, ZINC SULFATEKrogerf6829be4-e3b7-7ff2-e053-2995a90a80fc2023-12-20WarningsExact identifier
application number: M018
Rite Aid Multi-Symptom Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATERite Aid Corporationefa7d208-9d42-13c7-e053-2a95a90a11b32023-12-20WarningsExact identifier
application number: M018
Signature Care Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMBetter Living Brands LLCea358e01-f03e-454b-bae1-6c83da44c3692023-12-20WarningsExact identifier
application number: M018
TopCare Health Original Eye DropsTETRAHYDROZOLINE HCLTopco Associates LLC9c61a56a-c1a9-2846-e053-2995a90a755b2023-12-20WarningsExact identifier
application number: M018
Signature Care Eye Drops A.C.TETRAHYDROZOLINE HCL, ZINC SULFATEBetter Living Brands LLCf685aca4-93d0-26d9-e053-2995a90a6e512023-12-20WarningsExact identifier
application number: M018
Kroger Lubricant EyeCARBOXYMETHYLCELLULOSE SODIUMThe Kroger Co.046f4ebc-d8f9-4755-b6ba-790fe86f31282023-12-20WarningsExact identifier
application number: M018
Kroger Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEKroger Companyf7ad77fc-d890-25b9-e053-6394a90a2b122023-12-20WarningsExact identifier
application number: M018
TopCare Health Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Topco Associates LLC9c617e34-fc66-1a5b-e053-2995a90ace2c2023-12-20WarningsExact identifier
application number: M018
Equaline Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEUnited Natural Foods, Inc.f7602789-179a-edfc-e053-6294a90a08442023-12-20WarningsExact identifier
application number: M018
Topcare Health Ultra Itch Relief Astringent Eye DropsTETRAHYDROZOLINE HCL, ZINC SULFATETopco Associates LLC9c617e34-fc64-1a5b-e053-2995a90ace2c2023-12-20WarningsExact identifier
application number: M018
Topcare Health Artificial TearsPOLYVINYL ALCOHOL, POVIDONETopco Associates LLC9c614c0e-5862-682f-e053-2a95a90abc092023-12-20WarningsExact identifier
application number: M018
Topcare Health Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTopco Assoc LLC9c6284f9-00bb-37b5-e053-2a95a90ae2ee2023-12-20WarningsExact identifier
application number: M018
HEB Dry Eye Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400HEBf80023cf-8e42-780a-e053-6294a90a66cd2023-12-20WarningsExact identifier
application number: M018
TopCare Health Advanced Moisturizing Plus Redness ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLTopco Associates LLC9c6193a6-d822-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
application number: M018
Topcare Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDETopco Assoc LLC9c6193a6-d824-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
application number: M018
HEB Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMHEB5d522e4d-d647-486f-a947-25c14b1417fa2023-12-20WarningsExact identifier
application number: M018
HEB A.C. Eye DropsTETRAHYDROZOLINE HCL, ZINC SULFATEHEB Grocery Company., LPf680a8c1-dc91-7a52-e053-2a95a90a571e2023-12-20WarningsExact 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