Artificial Tears

Product NDC: 55651-008
11-digit product format: 556510008
Labeler code: 55651
Product ID: 55651-008_4748d0f4-e97c-a0c1-e063-6394a90ac311
Type: HUMAN OTC DRUG
Nonproprietary name: polyvinyl alcohol, povidone
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: KC Pharmaceuticals, Inc.
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2003-11-25
Substance: POLYVINYL ALCOHOL, UNSPECIFIED; POVIDONE, UNSPECIFIED
Active strength: 5; 6 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Artificial Tears
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POVIDONE, UNSPECIFIED	6 mg/mL
POLYVINYL ALCOHOL, UNSPECIFIED	5 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
598050	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
eb6eb6c4-1609-407b-84e4-c7509811f3c0	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
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
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
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
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
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55651-008-01	Artificial Tears	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15		4
55651-008-01	Artificial Tears	1 in 1 CARTON	SOLUTION/ DROPS	1		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POLYVINYL ALCOHOL	ACTIVE INGREDIENT	532B59J990	ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]	1
POVIDONE	ACTIVE INGREDIENT	FZ989GH94E	ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]	1
POLYVINYL ALCOHOL	ACTIVE MOIETY	532B59J990	ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]	1
POVIDONE	ACTIVE MOIETY	FZ989GH94E	ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]	1
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]	1
POTASSIUM CHLORIDE	INACTIVE INGREDIENT	660YQ98I10	ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]	1
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]	1
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	INACTIVE INGREDIENT	22ADO53M6F	ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]	1
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	INACTIVE INGREDIENT	593YOG76RN	ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55651-008	ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20250101_eb6eb6c4-1609-407b-84e4-c7509811f3c0.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
532B59J990	POLYVINYL ALCOHOL, UNSPECIFIED	9002-89-5	POLYVINYL ALCOHOL, UNSPECIFIED
FZ989GH94E	POVIDONE, UNSPECIFIED	9003-39-8	POVIDONE, UNSPECIFIED

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
598050	polyvinyl alcohol 0.5 % / povidone 0.6 % Ophthalmic Solution	PSN	eb6eb6c4-1609-407b-84e4-c7509811f3c0	4
598050	polyvinyl alcohol 0.005 ML/ML / povidone 6 MG/ML Ophthalmic Solution	SCD	eb6eb6c4-1609-407b-84e4-c7509811f3c0	4
598050	polyvinyl alcohol 0.5 % / povidone 0.6 % Ophthalmic Solution	SY	eb6eb6c4-1609-407b-84e4-c7509811f3c0	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55651-008-01	55651000801	1 BOTTLE, DROPPER in 1 CARTON (55651-008-01) / 15 mL in 1 BOTTLE, DROPPER	2003-11-25	0000-00-00	No	No	Current