Eye Lubricant

Product NDC: 67510-0663
11-digit product format: 675100663
Labeler code: 67510
Product ID: 67510-0663_d450c339-baf6-0434-e053-2995a90a2717
Type: HUMAN OTC DRUG
Nonproprietary name: polyethylene gloycol, propylene glycol
Dosage form: LIQUID
Route: OPHTHALMIC
Labeler: Kareway Product, Inc.
Application: part349
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-10-01
Marketing end: 0000-00-00
Substance: POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
Active strength: 4 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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	67510-0663		I	Inactivated by FDA		2026-10-16
excluded package	package	67510-0663	67510-0663-1	I	Inactivated by FDA		2026-10-16

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 · 47 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	67510-0663-1	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	67510-0663-1	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	67510-0663-1	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	67510-0663-1	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	67510-0663-1	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	67510-0663-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67510-0663-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67510-0663-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67510-0663-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67510-0663-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67510-0663-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67510-0663-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67510-0663-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67510-0663-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67510-0663-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67510-0663-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	67510-0663-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	67510-0663-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	67510-0663-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	67510-0663-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	67510-0663-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	67510-0663-5	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	67510-0663-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	67510-0663-3	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
67510-0663-3	2020-04-30	9d75b9cf-e342-f424-e053-dadaa90a57ce	Pure-Aid Lubricant Eye Drops Ultra
67510-0663-5	2020-04-30	9d75b9cf-e342-f424-e053-dadaa90a57ce	Pure-Aid Lubricant Eye Drops Ultra
67510-0663-1	2020-01-31	9d75b9d0-97fc-f424-e053-dadaa90a57ce	Drug Facts
67510-0663-3	2020-01-31	9d75b9cf-e342-f424-e053-dadaa90a57ce	Pure-Aid Lubricant Eye Drops Ultra
67510-0663-5	2020-01-31	9d75b9cf-e342-f424-e053-dadaa90a57ce	Pure-Aid Lubricant Eye Drops Ultra

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POLYETHYLENE GLYCOL 400	ACTIVE INGREDIENT	B697894SGQ	EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]	2
POLYETHYLENE GLYCOL 400	ACTIVE INGREDIENT	B697894SGQ	EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]	2
PROPYLENE GLYCOL	ACTIVE INGREDIENT	6DC9Q167V3	EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]	2
PROPYLENE GLYCOL	ACTIVE INGREDIENT	6DC9Q167V3	EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]	2
POLYETHYLENE GLYCOL 400	ACTIVE MOIETY	B697894SGQ	EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]	2
POLYETHYLENE GLYCOLS	ACTIVE MOIETY	3WJQ0SDW1A	EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]	2
PROPYLENE GLYCOL	ACTIVE MOIETY	6DC9Q167V3	EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]	2
PROPYLENE GLYCOL	ACTIVE MOIETY	6DC9Q167V3	EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]	2
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]	2
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]	2
POTASSIUM CHLORIDE	INACTIVE INGREDIENT	660YQ98I10	EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]	2
POTASSIUM CHLORIDE	INACTIVE INGREDIENT	660YQ98I10	EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	EYE LUBRICANT (POLYETHYLENE GLOYCOL, PROPYLENE GLYCOL) LIQUID [KAREWAY PRODUCT, INC.]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
B697894SGQ	POLYETHYLENE GLYCOL 400	25322-68-3	POLYETHYLENE GLYCOL 400
6DC9Q167V3	PROPYLENE GLYCOL	57-55-6	PROPYLENE GLYCOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67510-0663-5	67510066305	1 BOTTLE in 1 BOX (67510-0663-5) > 15 mL in 1 BOTTLE	1 bottle	2012-10-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pure-Aid Lubricant Eye Drops Ultra	Kareway Product, Inc.	2023-01-27	HUMAN OTC DRUG LABEL	5
Drug Facts	Kareway Product, Inc.	2012-06-21	HUMAN OTC DRUG LABEL	2