FreshKote Preservative Free Lubricant Eye Drops

Product NDC: 71776-001
11-digit product format: 717760001
Labeler code: 71776
Product ID: 71776-001_4ef5ad57-d826-8962-e063-6294a90a401a
Type: HUMAN OTC DRUG
Nonproprietary name: Povidone, Polyvinyl Alcohol
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Eyevance Pharmaceuticals
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-03-13
Substance: POVIDONE; POLYVINYL ALCOHOL, UNSPECIFIED
Active strength: 20; 27 g/1000mL; g/1000mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 27 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71776-001-03	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71776-001-10	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71776-001-03	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71776-001-10	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71776-001-03	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71776-001-10	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71776-001-03	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71776-001-10	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71776-001-03	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71776-001-10	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71776-001-03	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71776-001-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71776-001-03	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71776-001-10	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71776-001-03	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71776-001-10	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71776-001-03	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71776-001-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: FreshKote Preservative Free Lubricant Eye Drops
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POVIDONE	20 g/1000mL
POLYVINYL ALCOHOL, UNSPECIFIED	27 g/1000mL

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
630977	Internal RxNorm lookup
630981	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
f51c50c3-43ae-4169-9d2b-22b239461dd1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71776-001-03	2025-01-30	C162847	48780-1	2cef2736-9274-d83d-e063-dadaa90ab31f	FRESHKOTE ® Preservative Free LUBRICANT EYE DROPS
71776-001-10	2025-01-30	C162847	48780-1	2cef2736-9274-d83d-e063-dadaa90ab31f	FRESHKOTE ® Preservative Free LUBRICANT EYE DROPS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71776-001-03	FreshKote Preservative Free Lubricant Eye Drops	30 in 1 BOX	SOLUTION	30	6
71776-001-03	FreshKote Preservative Free Lubricant Eye Drops	0.3 mL in 1 VIAL, SINGLE-USE	SOLUTION	0.3	6
71776-001-10	FreshKote Preservative Free Lubricant Eye Drops	1 in 1 BOX	SOLUTION	1	6
71776-001-10	FreshKote Preservative Free Lubricant Eye Drops	10 mL in 1 BOTTLE, DROPPER	SOLUTION	10	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71776-001-10	ML - Milliliter	71776-001	6d98ddf3-682f-400e-8fa0-3944539a6a04	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71776-001	FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS (POVIDONE, POLYVINYL ALCOHOL) SOLUTION [EYEVANCE PHARMACEUTICALS]	5	Current NDC, Legacy NDC, 4 package rows	20231006_f51c50c3-43ae-4169-9d2b-22b239461dd1.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OASIS Tears Preservative-Free Lubricant Eye	GLYCERIN	OASIS Medical, Inc.	d9d71b1d-82a6-42e7-9ef2-2d041daef936	2024-12-23	Warnings	Exact identifier application number: M018
Ancient Secrets Breathe Again	SODIUM CHLORIDE	LOTUS BRANDS, INC.	c6d2bab0-d363-4c09-a71b-ae15db915b37	2024-12-18	Warnings	Exact identifier application number: M018
TheraTears Extra	CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	MEDTECH PRODUCTS INC	77f504c1-b8e0-4371-ac3e-9d453d84714b	2024-12-13	Warnings	Exact identifier application number: M018
TheraTears Extra	CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED	MEDTECH PRODUCTS INC	f1845041-9d8d-42a0-a2cb-68def7a5aac7	2024-12-13	Warnings	Exact identifier application number: M018
Fendall Pure Flow	PURIFIED WATER	Honeywell Safety Products USA, Inc.	afda6fc3-7615-b0be-e053-2995a90a6208	2024-12-10	Warnings	Exact identifier application number: M018
Systane Nighttime	MINERAL OIL AND WHITE PETROLATUM	Alcon Laboratories, Inc.	4689c59c-5721-3f91-6c85-e41501998fd0	2024-12-05	Warnings	Exact identifier application number: M018
GenTeal Tears NIGHT-TIME	MINERAL OIL, WHITE PETROLATUM	Alcon Laboratories, Inc.	9d5998a7-4f59-4293-87da-8419650a524d	2024-12-05	Warnings	Exact identifier application number: M018
Visine Red Eye Total Comfort and Tears Dry Eye Relief	TETRAHYDROZOLINE HCL, POLYETHYLENE GLYCOL 400, ZINC SULFATE	Kenvue Brands LLC	0bc0d6e7-9195-db6b-e063-6294a90aef04	2024-11-14	Warnings	Exact identifier application number: M018
Visine Red Eye Comfort	TETRAHYDROZOLINE HYDROCHLORIDE	Kenvue Brands LLC	d7abd7cb-e094-481f-bea5-a5983e2c9ef4	2024-11-13	Warnings	Exact identifier application number: M018
Visine Red Eye Hydrating Comfort Eye Drops	TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400	Kenvue Brands LLC	a9a90de6-3172-4d34-984b-f4442f880e3d	2024-11-13	Warnings	Exact identifier application number: M018
Visine Dry Eye Relief	POLYETHYLENE GLYCOL 400	Kenvue Brands LLC	2de7a41d-661d-495f-89b4-5690664a3a3d	2024-11-13	Warnings	Exact identifier application number: M018
Visine Dry Eye Relief Eye Drops	POLYETHYLENE GLYCOL 400	Kenvue Brands LLC	d9d3f000-3ce4-4ba2-a7fb-491b44eb3fa1	2024-11-13	Warnings	Exact identifier application number: M018
Visine Dry Eye Relief	POLYETHYLENE GLYCOL 400	Kenvue Brands LLC	a4c57620-778f-4434-9105-ead2f85c5884	2024-11-13	Warnings	Exact identifier application number: M018
Visine A.C. Itchy Eye Relief	TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE, UNSPECIFIED FORM	Kenvue Brands LLC	257b9666-0163-499b-9673-bf6f4d6899b1	2024-11-13	Warnings	Exact identifier application number: M018
Eyewash Station Additive Concentrate	CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL	Acme United Corporation	f19fbe28-b928-7c6e-e053-2995a90a43cb	2024-11-09	Warnings	Exact identifier application number: M018
RUGBY EYE WASH	WATER, PURIFIED	A-S Medication Solutions	0773e558-2f46-494c-888a-3bc517202b65	2024-11-08	Warnings	Exact identifier application number: M018
Clear Eyes Triple Relief	POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE	Prestige Brands Holdings, Inc.	1269a1a6-843d-4d08-bb3c-c1f3d2e7080d	2024-10-25	Warnings	Exact identifier application number: M018
Clear Eyes Cooling Redness Relief	GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE	Prestige Brands Holdings, Inc.	38d14e99-e4c8-431b-b106-578eeb38bf3c	2024-10-25	Warnings	Exact identifier application number: M018
EyS Eye Wash	WATER	Eyes-Plus LLC	1443f6bf-3a77-4a19-8585-0ec58efe042f	2024-10-15	Warnings	Exact identifier application number: M018
Eye Wash	WATER SOLUTION	Kroger Company	354402ad-581d-47e7-9fd3-933bef281ff4	2024-10-11	Warnings	Exact identifier application number: M018

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
532B59J990	POLYVINYL ALCOHOL, UNSPECIFIED	9002-89-5	POLYVINYL ALCOHOL, UNSPECIFIED

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
630981	FreshKote 2.7 % / 2 % Ophthalmic Solution	PSN	f51c50c3-43ae-4169-9d2b-22b239461dd1	6
630977	polyvinyl alcohol 2.7 % / povidone 2 % Ophthalmic Solution	PSN	f51c50c3-43ae-4169-9d2b-22b239461dd1	6
630981	polyvinyl alcohol 27 MG/ML / povidone 20 MG/ML Ophthalmic Solution [Freshkote]	SBD	f51c50c3-43ae-4169-9d2b-22b239461dd1	6
630977	polyvinyl alcohol 27 MG/ML / povidone 20 MG/ML Ophthalmic Solution	SCD	f51c50c3-43ae-4169-9d2b-22b239461dd1	6
630981	Freshkote (polyvinyl alcohol 1.8 % / polyvinyl alcohol 0.9 % / povidone 2 % ) Ophthalmic Solution	SY	f51c50c3-43ae-4169-9d2b-22b239461dd1	6
630981	Freshkote (polyvinyl alcohol 2.7 % / povidone 2 % ) Ophthalmic Solution	SY	f51c50c3-43ae-4169-9d2b-22b239461dd1	6
630977	polyvinyl alcohol 2.7 % / povidone 2 % Ophthalmic Solution	SY	f51c50c3-43ae-4169-9d2b-22b239461dd1	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71776-001-03	71776000103	30 VIAL, SINGLE-USE in 1 BOX (71776-001-03) / .3 mL in 1 VIAL, SINGLE-USE	2020-12-06	0000-00-00	No	No	Current
71776-001-10	71776000110	1 BOTTLE, DROPPER in 1 BOX (71776-001-10) / 10 mL in 1 BOTTLE, DROPPER	2019-03-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FRESHKOTE ® Preservative Free LUBRICANT EYE DROPS	Eyevance Pharmaceuticals \| ExcelVision	2026-04-08	HUMAN OTC DRUG LABEL	6