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
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 24 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HEB Advanced Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	HEB Grocery Company, LP	f76281d6-3aea-349b-e053-6394a90afca2	2023-12-20	Warnings	Exact identifier application number: M018
Equaline Eye Drops A.C.	TETRAHYDROZOLINE HCL, ZINC SULFATE	United Natural Foods, Inc.	f5f894f0-1ab0-4cad-e053-2995a90a7cba	2023-12-20	Warnings	Exact identifier application number: M018
Cleareyes Redness Relief	NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN	Lil' Drug Store Products, Inc.	39e4ab2b-ae12-4339-b219-109cf0f7f06a	2023-12-15	Warnings	Exact identifier application number: M018
GenTeal Tears (Moderate)	DEXTRAN 70, GLYCERIN, HYPROMELLOSE	Alcon Laboratories, Inc.	a2992597-3490-6a5c-be45-2b6fa15e1547	2023-12-15	Warnings	Exact identifier application number: M018
SYSTANE HYDRATION PF PRESERVATIVE FREE	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	db3a6c68-320b-46b0-83fa-6c29297a84a6	2023-12-15	Warnings	Exact identifier application number: M018
Systane	POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL	Alcon Research Ltd	14916d2c-a63d-491e-bd91-a61f300af38a	2023-12-15	Warnings	Exact identifier application number: M018
Systane	HYPROMELLOSE	Alcon Laboratories, Inc.	5f74b161-ae41-d0e2-6ed9-8deca55d2c0f	2023-12-15	Warnings	Exact identifier application number: M018
Systane Day and Night Value Pack	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL 0.3%	Alcon Laboratories, Inc.	df13ca6f-7ce1-455a-ae13-9bbc5e9d2e07	2023-12-15	Warnings	Exact identifier application number: M018
Systane Lubricant	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	15bc06ec-f3dc-3180-ca1a-106769a770ea	2023-12-15	Warnings	Exact identifier application number: M018
Systane ULTRA	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	a5c1c194-3db5-4f18-9cd1-97f7f84c3cff	2023-12-15	Warnings	Exact identifier application number: M018
Systane COMPLETE PF	PROPYLENE GLYCOL	Alcon Laboratories, Inc.	7eaa93ca-c843-4c89-921b-c76659410dce	2023-12-14	Warnings	Exact identifier application number: M018
BION TEARS	DEXTRAN, HYPROMELLOSE	Alcon Laboratories, Inc.	e48d82f0-2f18-e514-4caa-e397d6713b99	2023-12-14	Warnings	Exact identifier application number: M018
GenTeal Tears Severe	HYPROMELLOSE	Alcon Laboratories, Inc.	a57854fc-f3a2-4fbb-b718-cd06f87a721e	2023-12-14	Warnings	Exact identifier application number: M018
BION TEARS	DEXTRAN, HYPROMELLOSE	Alcon Laboratories, Inc.	538c2a89-efb5-4132-b678-5a78f23cb713	2023-12-14	Warnings	Exact identifier application number: M018
GenTeal Tears Gel Drops	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	84388a75-9d11-48ce-bf5a-88f0580d2d03	2023-12-14	Warnings	Exact identifier application number: M018
Alcon Tears Lubricant Eye Drops	HYPROMELLOSE 2910	Alcon Laboratories, Inc.	89302e2b-882b-48d5-8df7-be37859b48ba	2023-12-14	Warnings	Exact identifier application number: M018
GenTeal Tears Moderate Preservative Free	DEXTRAN 70, HYPROMELLOSE 2910	Alcon Laboratories, Inc.	37686e54-e64d-47c8-b082-b944a23cf6f1	2023-12-14	Warnings	Exact identifier application number: M018
Altachlore Sodium Chloride Hypertonicity	SODIUM CHLORIDE	Altaire Pharmaceuticals Inc.	dc0d94d8-4475-4956-8ded-bdb9496074e4	2023-12-09	Warnings	Exact identifier application number: M018
Altalube	MINERAL OIL AND PETROLATUM	Altaire Pharmaceuticals Inc.	eb65004c-c3a7-4079-bd75-f2857d30c68a	2023-12-09	Warnings	Exact identifier application number: M018
Good Neighbor Pharmacy Artifical Tears Lubricant Eye Drops	POLYVINYL ALCOHOL, POVIDONE	Proficient Rx LP	73e12596-6dd5-4cd2-83ed-992e1211b4b8	2023-12-01	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