Leader Restorative Formula Lubricant Eye Drops

Product NDC: 70000-0013
11-digit product format: 700000013
Labeler code: 70000
Product ID: 70000-0013_4cccde20-131f-1e39-e063-6294a90ad00e
Type: HUMAN OTC DRUG
Nonproprietary name: propylene glycol
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Cardinal Health
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-04-30
Marketing end: 2027-09-30
Substance: PROPYLENE GLYCOL
Active strength: .6 g/100mL
NDC exclude flag: No
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70000-0013	70000-0013-2	D	Discontinued by firm		2026-10-21

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70000-0013	70000-0013-2	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70000-0013	70000-0013-2	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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: Leader Restorative Formula Lubricant Eye Drops

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROPYLENE GLYCOL	.6 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6DC9Q167V3	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1041798	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
87fef7e4-e5a8-4aad-94d2-f80f34826d97	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70000-0013-1	Leader Restorative Formula Lubricant Eye Drops	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15	7
70000-0013-1	Leader Restorative Formula Lubricant Eye Drops	1 in 1 BOX	SOLUTION/ DROPS	1	7
70000-0013-2	Leader Restorative Formula Lubricant Eye Drops	2 in 1 BOX	SOLUTION/ DROPS	2	7
70000-0013-2	Leader Restorative Formula Lubricant Eye Drops	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0013-1	ML - Milliliter	70000-0013	e5989887-f32e-4344-94f1-a13d2f786986	1	2021-06-02
70000-0013-2	ML - Milliliter	70000-0013	12082d80-c43d-4f18-96ff-e3932737c64b	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70000-0013	LEADER RESTORATIVE FORMULA LUBRICANT EYE DROPS (PROPYLENE GLYCOL) SOLUTION/ DROPS [CARDINAL HEALTH]	4	Current NDC, Legacy NDC, 4 package rows	20240104_87fef7e4-e5a8-4aad-94d2-f80f34826d97.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 23 of 25 · 486 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kroger Lubricant Eye	CARBOXYMETHYLCELLULOSE SODIUM	The Kroger Co.	046f4ebc-d8f9-4755-b6ba-790fe86f3128	2023-12-20	Warnings	Exact identifier application number: M018
Kroger Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Kroger Company	f7ad77fc-d890-25b9-e053-6394a90a2b12	2023-12-20	Warnings	Exact identifier application number: M018
TopCare Health Dry Eye Relief Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Topco Associates LLC	9c617e34-fc66-1a5b-e053-2995a90ace2c	2023-12-20	Warnings	Exact identifier application number: M018
Equaline Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	United Natural Foods, Inc.	f7602789-179a-edfc-e053-6294a90a0844	2023-12-20	Warnings	Exact identifier application number: M018
Topcare Health Ultra Itch Relief Astringent Eye Drops	TETRAHYDROZOLINE HCL, ZINC SULFATE	Topco Associates LLC	9c617e34-fc64-1a5b-e053-2995a90ace2c	2023-12-20	Warnings	Exact identifier application number: M018
Topcare Health Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Topco Associates LLC	9c614c0e-5862-682f-e053-2a95a90abc09	2023-12-20	Warnings	Exact identifier application number: M018
Topcare Health Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Topco Assoc LLC	9c6284f9-00bb-37b5-e053-2a95a90ae2ee	2023-12-20	Warnings	Exact identifier application number: M018
HEB Dry Eye Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	HEB	f80023cf-8e42-780a-e053-6294a90a66cd	2023-12-20	Warnings	Exact identifier application number: M018
TopCare Health Advanced Moisturizing Plus Redness Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Topco Associates LLC	9c6193a6-d822-1b27-e053-2995a90ab3cf	2023-12-20	Warnings	Exact identifier application number: M018
Topcare Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Topco Assoc LLC	9c6193a6-d824-1b27-e053-2995a90ab3cf	2023-12-20	Warnings	Exact identifier application number: M018
HEB Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	HEB	5d522e4d-d647-486f-a947-25c14b1417fa	2023-12-20	Warnings	Exact identifier application number: M018
HEB A.C. Eye Drops	TETRAHYDROZOLINE HCL, ZINC SULFATE	HEB Grocery Company., LP	f680a8c1-dc91-7a52-e053-2a95a90a571e	2023-12-20	Warnings	Exact identifier application number: M018
HEB Advanced Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	HEB Grocery Company, LP	f76281d6-3aea-349b-e053-6394a90afca2	2023-12-20	Warnings	Exact identifier application number: M018
Equaline Eye Drops A.C.	TETRAHYDROZOLINE HCL, ZINC SULFATE	United Natural Foods, Inc.	f5f894f0-1ab0-4cad-e053-2995a90a7cba	2023-12-20	Warnings	Exact identifier application number: M018
Cleareyes Redness Relief	NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN	Lil' Drug Store Products, Inc.	39e4ab2b-ae12-4339-b219-109cf0f7f06a	2023-12-15	Warnings	Exact identifier application number: M018
GenTeal Tears (Moderate)	DEXTRAN 70, GLYCERIN, HYPROMELLOSE	Alcon Laboratories, Inc.	a2992597-3490-6a5c-be45-2b6fa15e1547	2023-12-15	Warnings	Exact identifier application number: M018
SYSTANE HYDRATION PF PRESERVATIVE FREE	POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL	Alcon Laboratories, Inc.	db3a6c68-320b-46b0-83fa-6c29297a84a6	2023-12-15	Warnings	Exact identifier application number: M018
Systane	POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL	Alcon Research Ltd	14916d2c-a63d-491e-bd91-a61f300af38a	2023-12-15	Warnings	Exact identifier application number: M018
Systane	HYPROMELLOSE	Alcon Laboratories, Inc.	5f74b161-ae41-d0e2-6ed9-8deca55d2c0f	2023-12-15	Warnings	Exact identifier application number: M018
Systane Day and Night Value Pack	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL 0.3%	Alcon Laboratories, Inc.	df13ca6f-7ce1-455a-ae13-9bbc5e9d2e07	2023-12-15	Warnings	Exact identifier application number: M018

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6DC9Q167V3	PROPYLENE GLYCOL	57-55-6	PROPYLENE GLYCOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1041798	propylene glycol 0.6 % Ophthalmic Solution	PSN	87fef7e4-e5a8-4aad-94d2-f80f34826d97	7
1041798	propylene glycol 6 MG/ML Ophthalmic Solution	SCD	87fef7e4-e5a8-4aad-94d2-f80f34826d97	7
1041798	propylene glycol 0.6 % Ophthalmic Solution	SY	87fef7e4-e5a8-4aad-94d2-f80f34826d97	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70000-0013-1	70000001301	1 BOTTLE, DROPPER in 1 BOX (70000-0013-1) / 15 mL in 1 BOTTLE, DROPPER	2019-04-30	2027-09-30	No	No	Current
70000-0013-2	70000001302	2 BOTTLE, DROPPER in 1 BOX (70000-0013-2) > 15 mL in 1 BOTTLE, DROPPER	2019-04-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Leader Restorative Formula Lubricant Eye Drops (PLD)	Cardinal Health \| Daewoo Pharmaceutical Co., Ltd.	2026-03-12	HUMAN OTC DRUG LABEL	7