Artificial Tears

Product NDC: 41520-865
11-digit product format: 415200865
Labeler code: 41520
Product ID: 41520-865_9602d650-fc3f-0931-e053-2995a90a8058
Type: HUMAN OTC DRUG
Nonproprietary name: glycerin, hypromellose, polyethylene glycol 400
Dosage form: LIQUID
Route: OPHTHALMIC
Labeler: American Sales Company
Application: part349
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-09-06
Marketing end: 0000-00-00
Substance: GLYCERIN; POLYETHYLENE GLYCOL 400; HYPROMELLOSES
Active strength: 2 mg/mL; mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	41520-865		I	Inactivated by FDA		2026-09-14
excluded package	package	41520-865	41520-865-05	I	Inactivated by FDA		2026-09-14

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 · 36 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	41520-865-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	41520-865-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	41520-865-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	41520-865-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	41520-865-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	41520-865-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	41520-865-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	41520-865-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	41520-865-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	41520-865-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	41520-865-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	41520-865-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
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	41520-865-05	`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	41520-865-05	`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	41520-865-05	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	41520-865-05	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	41520-865-05	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	41520-865-05	`bd6a592717d7…`	`303034d00443…`

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
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
597b1cfd-7b31-5048-62be-ca5cd740da2f	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
41520-865-05	2022-01-28	C162847	48780-1	d6a99b39-6aff-a426-e053-dadaa90af4c2	CareOne Artificial Tears

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41520-865-05	Artificial Tears	15 mL in 1 BOTTLE	LIQUID	15		4
41520-865-05	Artificial Tears	1 in 1 BOX	LIQUID	1		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLYCERIN	ACTIVE INGREDIENT	PDC6A3C0OX	ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]	2
HYPROMELLOSES	ACTIVE INGREDIENT	3NXW29V3WO	ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]	2
POLYETHYLENE GLYCOL 400	ACTIVE INGREDIENT	B697894SGQ	ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]	2
GLYCERIN	ACTIVE MOIETY	PDC6A3C0OX	ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]	2
HYPROMELLOSES	ACTIVE MOIETY	3NXW29V3WO	ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]	2
POLYETHYLENE GLYCOL 400	ACTIVE MOIETY	B697894SGQ	ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]	2
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]	2
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]	2
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]	2
GLYCINE	INACTIVE INGREDIENT	TE7660XO1C	ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]	2
MAGNESIUM CHLORIDE	INACTIVE INGREDIENT	02F3473H9O	ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]	2
POTASSIUM CHLORIDE	INACTIVE INGREDIENT	660YQ98I10	ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]	2
SODIUM BORATE	INACTIVE INGREDIENT	91MBZ8H3QO	ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]	2
SODIUM LACTATE	INACTIVE INGREDIENT	TU7HW0W0QT	ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-865	ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]	4	Legacy NDC, 2 package rows	20191029_4c62432b-bd6d-46ac-a5fb-8dadfda04846.zip

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	4c62432b-bd6d-46ac-a5fb-8dadfda04846	4
259581	glycerin 2 MG/ML / hypromellose 2 MG/ML / polyethylene glycol 400 10 MG/ML Ophthalmic Solution	SCD	4c62432b-bd6d-46ac-a5fb-8dadfda04846	4
259581	glycerin 0.2 % / hypromellose 0.2 % / PEG 400 1 % Ophthalmic Solution	SY	4c62432b-bd6d-46ac-a5fb-8dadfda04846	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41520-865-05	41520086505	1 BOTTLE in 1 BOX (41520-865-05) > 15 mL in 1 BOTTLE	1 bottle	2010-09-10	0000-00-00	No	No	Current