Artificial Tears

Product NDC: 68071-4555
11-digit product format: 680714555
Labeler code: 68071
Product ID: 68071-4555_46050426-880b-d28c-e063-6294a90acc56
Type: HUMAN OTC DRUG
Nonproprietary name: Glycerin
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: NuCare Pharmaceuticals,Inc.
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-06-01
Substance: GLYCERIN; HYPROMELLOSES; POLYETHYLENE GLYCOL 400
Active strength: .002; .002; .01 mg/mg; mg/mg; mg/mg
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-4555-5	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-4555-5	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-4555-5	`1332a3947898…`	`d4bfe170f9cd…`

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
GLYCERIN	.002 mg/mg
HYPROMELLOSES	.002 mg/mg
POLYETHYLENE GLYCOL 400	.01 mg/mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
PDC6A3C0OX	Internal UNII lookup
3NXW29V3WO	Internal UNII lookup
B697894SGQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
259581	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
97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d	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
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
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
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
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
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
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#

Effective, Related label table
Effective	Related label
2024-06-11	GC Artificial Tears 181
2023-01-30	GC Artificial Tears 181
2021-02-19	GC Artificial Tears 181
2021-01-29	GC Artificial Tears 181

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-4555-5	Artificial Tears	15 mg in 1 BOTTLE	SOLUTION/ DROPS	15		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4555	ARTIFICIAL TEARS (GLYCERIN) SOLUTION/ DROPS [NUCARE PHARMACEUTICALS,INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240613_97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d.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 9 of 25 · 499 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Family Wellness Original Redness Relief Eye Drops	TETRAHYDROZOLINE HCL	Family Dollar Services, Inc.	fabf540a-8d5c-bb1c-e053-6394a90a75c2	2025-12-30	Warnings	Exact identifier application number: M018
Family Wellness Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Family Dollar Services, Inc.	facd329b-1923-61df-e053-6294a90ab738	2025-12-30	Warnings	Exact identifier application number: M018
Medics Choice Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	K.C. Pharmaceuticals, Inc.	9ddfc275-602f-413b-e053-2995a90a11cb	2025-12-30	Warnings	Exact identifier application number: M018
Medics Choice Eye Drops Seasonal Relief	TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE	KC Pharmaceuticals, Inc.	92bd8cb4-90ad-4a47-afa4-30d1fa658d62	2025-12-30	Warnings	Exact identifier application number: M018
DG Health Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Dolgencorp LLC	9c62f8a3-7cf5-40f9-e053-2a95a90afd86	2025-12-30	Warnings	Exact identifier application number: M018
Medics Choice Eye Drops Original Redness Reliever	TETRAHYDROZOLINE HYDROCHLORIDE	KC Pharmaceuticals, Inc.	e42cb1bf-b985-4a1b-9a9b-ac27c2a5d7be	2025-12-30	Warnings	Exact identifier application number: M018
Medics Choice Eye Drops Maximum Redness Relief	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	K.C. Pharmaceuticals, Inc.	f7131707-47af-d70a-e053-6394a90a418f	2025-12-30	Warnings	Exact identifier application number: M018
DG Original Eye Drops	TETRAHYDROZOLINE HCL	Dolgencorp LLC	9cb2123c-3ed4-ce8f-e053-2995a90a0ab8	2025-12-30	Warnings	Exact identifier application number: M018
Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	KC Pharmaceuticals, Inc.	eb6eb6c4-1609-407b-84e4-c7509811f3c0	2025-12-30	Warnings	Exact identifier application number: M018
Medics Choice Eye Drops Advanced	TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE	KC Pharmaceuticals, Inc.	ab906fd8-265c-4359-a920-d626366e245c	2025-12-30	Warnings	Exact identifier application number: M018
Medics Choice Fresh and Soothe Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	KC Pharmaceuticals, Inc.	1f65b91a-4eac-65c2-e063-6394a90a0295	2025-12-30	Warnings	Exact identifier application number: M018
DG Health Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400	Dolgencorp LLC	9cb20c3b-bf6d-8c7c-e053-2995a90aa485	2025-12-30	Warnings	Exact identifier application number: M018
DG Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Dolgencorp LLC	9cb27899-6c36-3c37-e053-2995a90a1d43	2025-12-30	Warnings	Exact identifier application number: M018
Publix Artificial Tears Eye Drops	POLYVINYL ALCOHOL, POVIDONE	Publix Super Markets, Inc.	f5d1394b-0fe8-c372-e053-2a95a90a1f78	2025-12-30	Warnings	Exact identifier application number: M018
Best Choice Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Best Choice	f5ba63f3-7966-81fe-e053-2995a90a342c	2025-12-30	Warnings	Exact identifier application number: M018
DG Maximum Strength Redness Relief	GLYCERIN, NAPHAZOLINE HCL	Dolgencorp, Inc	9cb261ed-b708-1189-e053-2a95a90a547d	2025-12-30	Warnings	Exact identifier application number: M018
Publix Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Publix Super Markets, Inc.	f7b0c3d6-0324-46c3-e053-6394a90a8241	2025-12-30	Warnings	Exact identifier application number: M018
Publix Moisturizing Relief Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Publix Super Markets, Inc.	9b391400-c53b-7c7b-e053-2995a90a2731	2025-12-30	Warnings	Exact identifier application number: M018
Publix High Performance Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Publix Super Markets, Inc.	9b402aa8-87cb-3928-e053-2995a90afa3c	2025-12-30	Warnings	Exact identifier application number: M018
Kroger Eye Drops Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	The Kroger Company	f76f08c5-0111-8bc5-e053-6294a90a16ee	2025-12-30	Warnings	Exact identifier application number: M018

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PDC6A3C0OX	GLYCERIN	56-81-5	GLYCERIN
B697894SGQ	POLYETHYLENE GLYCOL 400	25322-68-3	POLYETHYLENE GLYCOL 400

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
259581	glycerin 0.2 % / hypromellose 0.2 % / polyethylene glycol 400 1 % Ophthalmic Solution	PSN	97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d	4
259581	glycerin 2 MG/ML / hypromellose 2 MG/ML / polyethylene glycol 400 10 MG/ML Ophthalmic Solution	SCD	97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d	4
259581	glycerin 0.2 % / hypromellose 0.2 % / PEG 400 1 % Ophthalmic Solution	SY	97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4555-5	68071455505	15 mg in 1 BOTTLE (68071-4555-5)	15 mg	2019-11-18	0000-00-00	No	No	Current