Pure Eyes Sterile Eyes

Product NDC: 20146-7000
11-digit product format: 201467000
Labeler code: 20146
Product ID: 20146-7000_103fe3bc-124a-4ce6-a1b1-fa96935d0fd9
Type: HUMAN OTC DRUG
Nonproprietary name: Naphazoline Hydrochloride and Glycerin
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: SAMSON PHARMACEUTICAL
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-01-01
Substance: NAPHAZOLINE HYDROCHLORIDE; GLYCERIN
Active strength: .1; 2.5 mg/mL; mg/mL
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: 2027-12-31
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 · 30 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	20146-7000-1	`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	20146-7000-1	`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	20146-7000-1	`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	20146-7000-1	`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	20146-7000-1	`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	20146-7000-1	`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	20146-7000-1	`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	20146-7000-1	`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	20146-7000-1	`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	20146-7000-1	`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	20146-7000-1	`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	20146-7000-1	`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	20146-7000-1	`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	20146-7000-1	`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	20146-7000-1	`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: Pure Eyes Sterile Eyes
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPHAZOLINE HYDROCHLORIDE	.1 mg/mL
GLYCERIN	2.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MZ1131787D	Internal UNII lookup
PDC6A3C0OX	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
c0234e82-211f-4731-ac48-12db13b16e8a	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-01-30	Pure Eyes ® Sterile Eyes
2022-01-31	Pure Eyes ® Sterile Eyes
2022-01-28	Pure Eyes ® Sterile Eyes
2020-02-12	Pure Eyes ® Sterile Eyes
2020-01-31	Pure Eyes ® Sterile Eyes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
20146-7000-1	Pure Eyes Sterile Eyes	7 mL in 1 BOTTLE	SOLUTION/ DROPS	7		5
20146-7000-1	Pure Eyes Sterile Eyes	1 in 1 BLISTER PACK	SOLUTION/ DROPS	1		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Glycerin	ACTIVE INGREDIENT	PDC6A3C0OX	PURE EYES STERILE EYES (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [SAMSON PHARMACEUTICAL]	1
Naphazoline Hydrochloride	ACTIVE INGREDIENT	MZ1131787D	PURE EYES STERILE EYES (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [SAMSON PHARMACEUTICAL]	1
Glycerin	ACTIVE MOIETY	PDC6A3C0OX	PURE EYES STERILE EYES (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [SAMSON PHARMACEUTICAL]	1
Naphazoline	ACTIVE MOIETY	H231GF11BV	PURE EYES STERILE EYES (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [SAMSON PHARMACEUTICAL]	1
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	PURE EYES STERILE EYES (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [SAMSON PHARMACEUTICAL]	1
boric acid	INACTIVE INGREDIENT	R57ZHV85D4	PURE EYES STERILE EYES (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [SAMSON PHARMACEUTICAL]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	PURE EYES STERILE EYES (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [SAMSON PHARMACEUTICAL]	1
sodium borate	INACTIVE INGREDIENT	91MBZ8H3QO	PURE EYES STERILE EYES (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [SAMSON PHARMACEUTICAL]	1
water	INACTIVE INGREDIENT	059QF0KO0R	PURE EYES STERILE EYES (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [SAMSON PHARMACEUTICAL]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
20146-7000	PURE EYES STERILE EYES (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) SOLUTION/ DROPS [SAMSON PHARMACEUTICAL]	3	Current NDC, Legacy NDC, 2 package rows	20220201_c0234e82-211f-4731-ac48-12db13b16e8a.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 3 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Visine Red Eye Total Comfort Multi-Symptom	TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORM	Kenvue Brands LLC	5747edef-7a87-41d7-9594-6c78508b9ba2	2026-06-11	Warnings	Exact identifier application number: M018
Nano Eye Drop Serum	WATER. SORBITOL.1.2-HEXANEDIOL GLYCERIN HYALURONATESODIUM.	Shenzhen Yiyang Zhiting Technology Co., Ltd	539567d6-488a-9b01-e063-6394a90abece	2026-06-06	Warnings	Exact identifier application number: M018
REFRESH CELLUVISC	CARBOXYMETHYLCELLULOSE SODIUM	Allergan, Inc.	b32ed9e8-d091-4f16-b416-5a62cdfee49a	2026-06-05	Warnings	Exact identifier application number: M018
VitaPhyte Redness Reliever Lubricant Eye Drops	REDNESS RELIEVER LUBRICANT EYE DROPS	Guangzhou Liyan Cosmetics Technology Co., Ltd.	53d4e9b0-c9a0-797a-e063-6294a90ad0cf	2026-06-04	Warnings	Exact identifier application number: M018
Rohto Digi-Eye	HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE	The Mentholatum Company	5d6f37b9-b568-4cb6-92de-eb40779f3f8c	2026-06-03	Warnings	Exact identifier application number: M018
Visine Red Eye Hydrating Comfort Eye Drops	TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400	Savings Distributors LLC	558178eb-1eec-af0f-e063-6394a90afad9	2026-06-01	Warnings	Exact identifier application number: M018
C-More Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN	PROFOUND NUTRITION LIMITED	78f04ecb-da5e-468c-81fe-70f7c26b76c2	2026-06-01	Warnings	Exact identifier application number: M018
Peep Club	GLYCERIN	Peep Club Eyecare Corp.	513d1988-2827-28d8-e063-6294a90a8d1f	2026-05-28	Warnings	Exact identifier application number: M018
Blink Triple Care Preservative Free	POLYETHYLENE GLYCOL 400	Bausch & Lomb Incorporated	65e67990-78b7-4ce9-963b-6bed3a6bed07	2026-05-27	Warnings	Exact identifier application number: M018
Ripple	GLYCERIN, POVIDONE	CorneaCare Inc	3b5ba197-d501-681e-e063-6294a90aefb5	2026-05-24	Warnings	Exact identifier application number: M018
REFRESH LACRI-LUBE	MINERAL OIL, PETROLATUM	Allergan, Inc.	d232a44b-516d-4cdf-a4e7-c3a9a50dc7af	2026-05-15	Warnings	Exact identifier application number: M018
blink tears	POLYETHYLENE GLYCOL 400	Bausch & Lomb Incorporated	f1d07347-086f-43b2-aa5f-910764fc666e	2026-05-13	Warnings	Exact identifier application number: M018
Systane Pro PF	PROPYLENE GLYCOL	Alcon Laboratories, Inc.	a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f1	2026-05-12	Warnings	Exact identifier application number: M018
Sodium Hyaluronate Eye Drops	SODIUM HYALURONATE	Guangzhou Hechuang Commercial Service Co.,Ltd.	5187d136-15c6-517b-e063-6294a90a811d	2026-05-11	Warnings	Exact identifier application number: M018
Splash Tears	HYPROMELLOSE	LABORATORIOS SOPHIA, S.A. DE C.V.	a58a8478-9cc5-aa39-e053-2995a90a347d	2026-05-08	Warnings	Exact identifier application number: M018
iVIZIA Lubricant Eye Gel	POVIDONE	Thea Pharma Inc.	1f06ca1a-5270-9a82-e063-6294a90aed64	2026-04-29	Warnings	Exact identifier application number: M018
GoodSense Eye Drops Advanced Relief Moisturizer	DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Preferred PHarmaceuticals Inc.	011473a8-26d5-4661-b3c0-745f9b6aa1d8	2026-04-29	Warnings	Exact identifier application number: M018
REFRESH TEARS PF	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN	Allergan, Inc.	9e1cba7b-84ed-47f3-b19a-121992834350	2026-04-24	Warnings	Exact identifier application number: M018
Sodium Chloride	SODIUM CHLORIDE	Method Pharmaceuticals, LLC	4b08859e-65bd-8255-e063-6394a90af614	2026-04-23	Warnings	Exact identifier application number: M018
Pure Eyes Sterile Eyes	NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN	SAMSON PHARMACEUTICAL	c0234e82-211f-4731-ac48-12db13b16e8a	2026-04-21	Warnings	Exact identifier application number: M018 ndc (product): 20146-7000

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

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	c0234e82-211f-4731-ac48-12db13b16e8a	5
1046700	glycerin 2.5 MG/ML / naphazoline hydrochloride 0.12 MG/ML Ophthalmic Solution	SCD	c0234e82-211f-4731-ac48-12db13b16e8a	5
1046700	glycerin 0.25 % / naphazoline HCl 0.012 % Ophthalmic Solution	SY	c0234e82-211f-4731-ac48-12db13b16e8a	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
20146-7000-1	20146700001	1 BOTTLE in 1 BLISTER PACK (20146-7000-1) / 7 mL in 1 BOTTLE	1 bottle	2015-01-01	0000-00-00	No	No	Current