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: POLYVINYL ALCOHOL; POVIDONE, UNSPECIFIED
Active strength: 14; 6 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POVIDONE, UNSPECIFIED	6 mg/mL
POLYVINYL ALCOHOL	14 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FZ989GH94E	Internal UNII lookup
532B59J990	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
c13c5f91-50df-471c-a7c9-1747a2ac1250	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
64108-212-12	2021-03-02	c13c5f91-50df-471c-a7c9-1747a2ac1250
64108-212-12	2021-03-02	c13c5f91-50df-471c-a7c9-1747a2ac1250
64108-212-13	2021-03-02	c13c5f91-50df-471c-a7c9-1747a2ac1250
64108-212-13	2021-03-02	c13c5f91-50df-471c-a7c9-1747a2ac1250
64108-212-65	2021-03-02	c13c5f91-50df-471c-a7c9-1747a2ac1250
64108-212-65	2021-03-02	c13c5f91-50df-471c-a7c9-1747a2ac1250
64108-212-12	2021-01-29	c13c5f91-50df-471c-a7c9-1747a2ac1250
64108-212-12	2021-01-29	c13c5f91-50df-471c-a7c9-1747a2ac1250
64108-212-13	2021-01-29	c13c5f91-50df-471c-a7c9-1747a2ac1250
64108-212-13	2021-01-29	c13c5f91-50df-471c-a7c9-1747a2ac1250
64108-212-65	2021-01-29	c13c5f91-50df-471c-a7c9-1747a2ac1250
64108-212-65	2021-01-29	c13c5f91-50df-471c-a7c9-1747a2ac1250

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64108-212-10	MINIDROPS	0.5 mL in 1 VIAL, SINGLE-USE	LIQUID	0.5	9
64108-212-12	MINIDROPS	30 in 1 BOX	LIQUID	30	9
64108-212-13	MINIDROPS	5 in 1 BOX	LIQUID	5	9
64108-212-65	MINIDROPS	65 in 1 BOX	LIQUID	65	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64108-212-12	EA - Each	64108-212	02c2830e-4730-414a-956e-31121c823bca	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POLYVINYL ALCOHOL	ACTIVE INGREDIENT	532B59J990	MINIDROPS (LUBRICANT EYE DROPS) LIQUID [OPTICS LABORATORY, INC]	2
POVIDONE K30	ACTIVE INGREDIENT	U725QWY32X	MINIDROPS (LUBRICANT EYE DROPS) LIQUID [OPTICS LABORATORY, INC]	2
POLYVINYL ALCOHOL	ACTIVE MOIETY	532B59J990	MINIDROPS (LUBRICANT EYE DROPS) LIQUID [OPTICS LABORATORY, INC]	2
POVIDONE K30	ACTIVE MOIETY	U725QWY32X	MINIDROPS (LUBRICANT EYE DROPS) LIQUID [OPTICS LABORATORY, INC]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	MINIDROPS (LUBRICANT EYE DROPS) LIQUID [OPTICS LABORATORY, INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	MINIDROPS (LUBRICANT EYE DROPS) LIQUID [OPTICS LABORATORY, INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64108-212	MINIDROPS (LUBRICANT EYE DROPS) LIQUID [OPTICS LABORATORY, INC]	7	Current NDC, Legacy NDC, 4 package rows	20241218_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 1 of 26 · 509 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TheraTears	CARBOXYMETHYLCELLULOSE SODIUM	MEDTECH PRODUCTS INC	17a01236-130f-495b-9f8d-92b6a23b2dc5	2026-09-09	Warnings	Exact identifier application number: M018
Leader Eye Drops Redness Relief	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Cardinal Health	aee4bbe2-4f11-4c54-be8b-df48b3ba4f3a	2026-09-09	Warnings	Exact identifier application number: M018
Leader Artificial Tears 15 mL	POLYVINYL ALCOHOL, POVIDONE	Cardinal Health	8cccc589-3a8e-baad-e053-2a95a90ab8c7	2026-09-09	Warnings	Exact identifier application number: M018
Clear Eyes Nighttime	GLYCERIN	Prestige Brands Holdings, Inc.	af75e2f7-81dd-43e0-a390-b52bbfbebf62	2026-09-08	Warnings	Exact identifier application number: M018
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS	POVIDONE, POLYVINYL ALCOHOL SOLUTION	Harrow Eye, LLC	049e9cc9-0663-53bc-e063-6294a90a2c4f	2026-09-04	Warnings	Exact identifier application number: M018
Dr.Harry EYES PROTECTION	POLYETHYLENE GLYCOL 400 1% EYES PROTECTION	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5a9fe033-89d3-da62-e063-6294a90a4503	2026-09-03	Warnings	Exact identifier application number: M018
REFRESH LIQUIGEL	CARBOXYMETHYLCELLULOSE SODIUM	Allergan, Inc.	4b8b2f6a-4b89-446c-9e5b-9b83c453a01d	2026-08-28	Warnings	Exact identifier application number: M018
Rohto Optic Glow	NAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOL	The Mentholatum Company	df9c5f7c-96e6-4b2b-b8cb-21a6a3342dff	2026-08-20	Warnings	Exact identifier application number: M018
Rohto All-In-One	HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE	The Mentholatum Company	43e690e4-b381-46e3-838c-33aef5bdadde	2026-08-20	Warnings	Exact identifier application number: M018
Rohto Max Strength	NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80	The Mentholatum Company	e4b49550-1ca3-4bd7-854d-409b53fa5e26	2026-08-20	Warnings	Exact identifier application number: M018
Sodium Chloride	SODIUM CHLORIDE	YYBA CORP	597f3347-647c-3545-e063-6294a90abab2	2026-08-20	Warnings	Exact identifier application number: M018
Mineral Oil/White Petrolatum	MINERAL OIL/WHITE PETROLATUM	YYBA CORP	5967ef02-6770-bfd7-e063-6294a90a7904	2026-08-19	Warnings	Exact identifier application number: M018
Rohto Preservative Free Dry Aid	POVIDONE, PROPYLENE GLYCOL	The Mentholatum Company	f4b1974c-2412-45f6-b79d-88b8a0bcb608	2026-08-18	Warnings	Exact identifier application number: M018
Rohto Dry-Aid	POVIDONE, PROPYLENE GLYCOL	The Mentholatum Company	8ea5c6c9-48f4-406a-a2cb-9280c546d87d	2026-08-18	Warnings	Exact identifier application number: M018
Leader Dry Eye Relief Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	CARDINAL HEALTH 110, LLC. DBA LEADER	2ded4bda-b3c3-4521-8701-5c8446fd148b	2026-08-17	Warnings	Exact identifier application number: M018
Mineral Oil/White Petrolatum	MINERAL OIL/WHITE PETROLATUM	YYBA CORP	5905b300-6f1f-a61f-e063-6394a90a1123	2026-08-14	Warnings	Exact identifier application number: M018
SYSTANE HYDRATION PF PRESERVATIVE FREE	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	8936f66f-10fe-44ab-a26e-dd8b05dfa997	2026-08-10	Warnings	Exact identifier application number: M018
Dr. Shitong Photon Energy Eye Care Liquid	TETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUID	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	58ace434-55ef-17ef-e063-6294a90aa878	2026-08-10	Warnings	Exact identifier application number: M018
Systane Pro PF	PROPYLENE GLYCOL	Alcon Laboratories, Inc.	23b3515f-fbe5-4398-b2df-8b2eccdd01e2	2026-08-10	Warnings	Exact identifier application number: M018
Leader Lubricant Eye Drops 30ct	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	CARDINAL HEALTH 110, LLC. DBA LEADER	8df69f2c-40c4-245c-e053-2a95a90a5406	2026-08-05	Warnings	Exact identifier application number: M018

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FZ989GH94E	POVIDONE, UNSPECIFIED	9003-39-8	POVIDONE, UNSPECIFIED

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1046287	MiniDrops 1.4 % / 0.6 % Ophthalmic Solution	PSN	c13c5f91-50df-471c-a7c9-1747a2ac1250	9
359969	polyvinyl alcohol 1.4 % / povidone 0.6 % Ophthalmic Solution	PSN	c13c5f91-50df-471c-a7c9-1747a2ac1250	9
1046287	polyvinyl alcohol 0.014 ML/ML / povidone 6 MG/ML Ophthalmic Solution [MiniDrops]	SBD	c13c5f91-50df-471c-a7c9-1747a2ac1250	9
359969	polyvinyl alcohol 0.014 ML/ML / povidone 6 MG/ML Ophthalmic Solution	SCD	c13c5f91-50df-471c-a7c9-1747a2ac1250	9
1046287	MiniDrops (polyvinyl alcohol 1.4 % / povidone 0.6 % ) Ophthalmic Solution	SY	c13c5f91-50df-471c-a7c9-1747a2ac1250	9
359969	polyvinyl alcohol 1.4 % / povidone 0.6 % Ophthalmic Solution	SY	c13c5f91-50df-471c-a7c9-1747a2ac1250	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64108-212-10	64108021210	.5 mL in 1 VIAL, SINGLE-USE (64108-212-10)	1991-04-01		No	No	Current
64108-212-12	64108021212	30 VIAL, SINGLE-USE in 1 BOX (64108-212-12) / .5 mL in 1 VIAL, SINGLE-USE (64108-212-10)	1991-04-01	0000-00-00	No	No	Current
64108-212-13	64108021213	5 VIAL, SINGLE-USE in 1 BOX (64108-212-13) / .5 mL in 1 VIAL, SINGLE-USE (64108-212-10)	1991-04-01	0000-00-00	No	No	Current
64108-212-65	64108021265	65 VIAL, SINGLE-USE in 1 BOX (64108-212-65) / .5 mL in 1 VIAL, SINGLE-USE (64108-212-10)	1991-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lubricant eye drops - Optics Laboratory, Inc \| Taiwan Biotech	Optics Laboratory, Inc \| Taiwan Biotech	2026-02-03	HUMAN OTC DRUG LABEL	9