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 25 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rugby Lubricating Drops	POLYVINYL ALCOHOL	A-S Medication Solutions	f2e26f85-4081-425b-9c81-ac2a079a5743	2023-11-10	Warnings	Exact identifier application number: M018
Saline	NASAL	GERI-CARE PHARMACEUTICAL CORP	d293cc13-4043-0d58-e053-2995a90a3fbc	2023-10-24	Warnings	Exact identifier application number: M018
Eyeganics Organic Tears	GLYCERIN	Eyeganics LLC	42470af7-a3ae-4e14-88e0-04cd92db4b37	2023-10-13	Warnings	Exact identifier application number: M018
Refresh Digital PF	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80	Allergan, Inc.	97e83e68-6374-4df4-93f6-d707fc32748d	2022-11-28	Warnings	Exact identifier application number: M018
Refresh Digital	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80	Allergan, Inc.	b2bd34d4-fab9-4f4b-9be2-5d30b55f5b81	2022-11-28	Warnings	Exact identifier application number: M018
REFRESH OPTIVE	CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN	Allergan, Inc.	7f8d88af-fd3b-4138-af61-f24c59ccebd7	2022-09-23	Warnings	Exact identifier application number: M018
REFRESH OPTIVE Advanced	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80	Allergan, Inc.	ebd0839e-2e1d-4e0e-986c-19f1f5c76358	2022-09-15	Warnings	Exact identifier application number: M018
REFRESH OPTIVE Advanced	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80	Allergan, Inc.	aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0	2022-09-01	Warnings	Exact identifier application number: M018
REFRESH TEARS	CARBOXYMETHYLCELLULOSE SODIUM	Allergan, Inc.	329d1fe0-4432-4565-b7b1-65666bd86526	2022-06-30	Warnings	Exact identifier application number: M018
REFRESH Optive Mega-3	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80	Allergan, Inc.	c5f2b3f2-2071-45bd-a010-67f848bc0233	2022-06-30	Warnings	Exact identifier application number: M018
REFRESH P.M.	MINERAL OIL, PETROLATUM	Allergan, Inc.	24365d64-cd94-41cc-a7e1-033102d98114	2022-06-30	Warnings	Exact identifier application number: M018
REFRESH PLUS	CARBOXYMETHYLCELLULOSE SODIUM	Allergan, Inc.	0f6a4b4b-cde6-4518-84b5-ce997f1154a7	2022-06-28	Warnings	Exact identifier application number: M018
CIRCLE K sterile eye drops	TETRAHYDROZOLINE HCL	Lil' Drug Store Products, Inc.	2c0e106c-16f6-ff4e-e063-6294a90a7dbb	2018-07-30	Warnings	Exact identifier application number: M018
Lil Drug Store Sterile Eye Drops Redness Reliever	TETRAHYDROZOLINE HCL	Lil' Drug Store Products, Inc.	2c0ea35c-ac52-1043-e063-6394a90a061c	2018-04-30	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