Leader Eye Drops Redness Relief

Product NDC: 70000-0010
11-digit product format: 700000010
Labeler code: 70000
Product ID: 70000-0010_5b11dcac-4699-9567-e063-6294a90aadf3
Type: HUMAN OTC DRUG
Nonproprietary name: Glycerin, Naphazoline hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Cardinal Health
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-04-30
Marketing end: 2027-11-30
Substance: GLYCERIN; NAPHAZOLINE HYDROCHLORIDE
Active strength: .25; .012 g/100mL; g/100mL
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
Current FDA listing: Yes

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 Eye Drops Redness Relief

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLYCERIN	.25 g/100mL
NAPHAZOLINE HYDROCHLORIDE	.012 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
PDC6A3C0OX	Internal UNII lookup
MZ1131787D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1046700	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
aee4bbe2-4f11-4c54-be8b-df48b3ba4f3a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e18001c8-33ae-5f66-9cdc-a39724bd4573	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70000-0010-1	Leader Eye Drops Redness Relief	1 in 1 CARTON	SOLUTION/ DROPS	1	5
70000-0010-1	Leader Eye Drops Redness Relief	15 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	15	5
70000-0010-2	Leader Eye Drops Redness Relief	15 mL in 1 BOTTLE, PLASTIC	SOLUTION/ DROPS	15	5
70000-0010-2	Leader Eye Drops Redness Relief	2 in 1 CARTON	SOLUTION/ DROPS	2	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0010-1	ML - Milliliter	70000-0010	a6ec9e55-719b-43a0-b8b9-249bd5df42f7	1	2020-01-03
70000-0010-2	ML - Milliliter	70000-0010	eec7eb83-d715-447f-921f-10e435fc9971	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70000-0010	LEADER EYE DROPS REDNESS RELIEF (GLYCERIN, NAPHAZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [CARDINAL HEALTH]	4	Current NDC, Legacy NDC, 4 package rows	20240103_aee4bbe2-4f11-4c54-be8b-df48b3ba4f3a.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 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Signature Care Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Better Living Brands LLC	5d7228ce-f108-4cc2-9aec-8b4548c3a155	2023-12-20	Warnings	Exact identifier application number: M018
Target Eye Drops Maximum Redness Relief Eye	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Target Corporation	1b26cd3b-4a05-4623-b320-01f22b3106ff	2023-12-20	Warnings	Exact identifier application number: M018
Kroger High Performance Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Kroger	d2aa8963-1922-02f3-e053-2a95a90a7d93	2023-12-20	Warnings	Exact identifier application number: M018
Kroger Eye Drops Seasonal Relief	TETRAHYDROZOLINE HCL, ZINC SULFATE	Kroger	f6829be4-e3b7-7ff2-e053-2995a90a80fc	2023-12-20	Warnings	Exact identifier application number: M018
Rite Aid Multi-Symptom Relief Eye Drops	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	Rite Aid Corporation	efa7d208-9d42-13c7-e053-2a95a90a11b3	2023-12-20	Warnings	Exact identifier application number: M018
Signature Care Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Better Living Brands LLC	ea358e01-f03e-454b-bae1-6c83da44c369	2023-12-20	Warnings	Exact identifier application number: M018
TopCare Health Original Eye Drops	TETRAHYDROZOLINE HCL	Topco Associates LLC	9c61a56a-c1a9-2846-e053-2995a90a755b	2023-12-20	Warnings	Exact identifier application number: M018
Signature Care Eye Drops A.C.	TETRAHYDROZOLINE HCL, ZINC SULFATE	Better Living Brands LLC	f685aca4-93d0-26d9-e053-2995a90a6e51	2023-12-20	Warnings	Exact identifier application number: M018
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PDC6A3C0OX	GLYCERIN	56-81-5	GLYCERIN
MZ1131787D	NAPHAZOLINE HYDROCHLORIDE	550-99-2	NAPHAZOLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1046700	glycerin 0.25 % / naphazoline HCl 0.012 % Ophthalmic Solution	PSN	aee4bbe2-4f11-4c54-be8b-df48b3ba4f3a	5
1046700	glycerin 2.5 MG/ML / naphazoline hydrochloride 0.12 MG/ML Ophthalmic Solution	SCD	aee4bbe2-4f11-4c54-be8b-df48b3ba4f3a	5
1046700	glycerin 0.25 % / naphazoline HCl 0.012 % Ophthalmic Solution	SY	aee4bbe2-4f11-4c54-be8b-df48b3ba4f3a	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70000-0010-1	70000001001	1 BOTTLE, PLASTIC in 1 CARTON (70000-0010-1) / 15 mL in 1 BOTTLE, PLASTIC	2019-04-30	2027-11-30	No	No	Current
70000-0010-2	70000001002	2 BOTTLE, PLASTIC in 1 CARTON (70000-0010-2) / 15 mL in 1 BOTTLE, PLASTIC	2019-04-30	2027-11-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Leader Eye Drops Redness Relief (PLD)	Cardinal Health \| KC Pharmaceuticals, Inc.	2026-09-09	HUMAN OTC DRUG LABEL	7