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 4 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SODIUM CHLORIDE 1 GRAM	SODIUM CHLORIDE	Gendose Pharmaceuticals, LLC	ce988ae5-61c6-4324-90e1-a94c8a54d0d0	2026-04-13	Warnings	Exact identifier application number: M018
Artificial Tears Lubricant Eye Drops	GLYCERIN, PROPYLENE GLYCOL	CVS Pharmacy	28297fee-8185-4869-8f39-5bfbf8bf8bfd	2026-04-13	Warnings	Exact identifier application number: M018
blink boost	GLYCERIN	Bausch & Lomb Incorporated	e765c224-1718-488f-99b2-976eb60c1d63	2026-04-13	Warnings	Exact identifier application number: M018
Retaine Ultra PF	POLYETHYLENE GLYCOL	OCuSOFT LLC	a5aaaf06-772d-44d3-8601-f978ddc48ad7	2026-04-13	Warnings	Exact identifier application number: M018
Exovisse Preservative-Free Artificial Tears	LUBRICANT EYE GEL DROPS	YD BIO USA, INC.	4f20191a-9124-2525-e063-6294a90a8428	2026-04-10	Warnings	Exact identifier application number: M018
WE FRESH Lubricating Eye Drops	GLYCERIN	Oculus Surgical, Inc.	4f253b5d-001b-091e-e063-6394a90a9d39	2026-04-09	Warnings	Exact identifier application number: M018
FreshKote Preservative Free Lubricant Eye Drops	POVIDONE, POLYVINYL ALCOHOL	Eyevance Pharmaceuticals	f51c50c3-43ae-4169-9d2b-22b239461dd1	2026-04-08	Warnings	Exact identifier application number: M018
Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye	SODIUM CHLORIDE	Walgreen Company	bda3b9db-5fc4-408c-a5ae-d1eeb3ee308d	2026-04-06	Warnings	Exact identifier application number: M018
LensMate Preservative-Free Artificial Tears	LUBRICANT EYE DROPS	YD BIO USA, INC.	4ebacb2b-9b2d-6bc1-e063-6294a90a3426	2026-04-05	Warnings	Exact identifier application number: M018
Exovisse Preservative-Free Artificial Tears	LUBRICANT EYE GEL DROPS	YD BIO USA, INC.	4ebc154b-128b-9dde-e063-6294a90ae00e	2026-04-05	Warnings	Exact identifier application number: M018
Sodium Chloride Ophthalmic 5 Percent Hypertonicity Eye	SODIUM CHLORIDE	Hanlim	4ee80e16-1bb1-8238-e063-6294a90aa719	2026-04-04	Warnings	Exact identifier application number: M018
Redness Relief	GLYCERIN, NAPHAZOLINE HCL	Pharmadel LLC	4c113bb9-814f-d92d-e063-6294a90a8302	2026-03-30	Warnings	Exact identifier application number: M018
Moisture Oyster	GLYCERIN	Moisture Oyster Inc	4e45317a-437f-4d88-e063-6294a90a98d0	2026-03-30	Warnings	Exact identifier application number: M018
Crocodile Tears Lubricant Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Crocodile Tears LLC	4df29336-ea0c-0484-e063-6294a90a685a	2026-03-26	Warnings	Exact identifier application number: M018
Artificial Tears Lubricant Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	KC Pharmaceuticals, Inc	4de5c844-85ca-ff9f-e063-6394a90ac12c	2026-03-25	Warnings	Exact identifier application number: M018
NOVEHA NIGHTTIME	WHITE PETROLATUM	Bullet Point LLC	4da24578-e98b-8ce1-e063-6294a90a8bf6	2026-03-24	Warnings	Exact identifier application number: M018
BLINK TRIPLE CARE	POLYETHYLENE GLYCOL 400	Bausch & Lomb Incorporated	a2b34eb0-001b-4f42-a8cc-c2a0150fafcc	2026-03-20	Warnings	Exact identifier application number: M018
SODIUM CHLORIDE HYPERTONICITY	SODIUM CHLORIDE	YYBA CORP	439653b9-99b8-4799-8d67-4a2ada9c6783	2026-03-20	Warnings	Exact identifier application number: M018
Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 Percent	SODIUM CHLORIDE	Altaire Pharmaceuticals Inc.	e13fd053-9420-490c-a43e-e14b0930cb4e	2026-03-18	Warnings	Exact identifier application number: M018
Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	KC Pharmaceuticals, Inc.	4d1d9b3a-ac5f-db27-e063-6294a90afc3f	2026-03-16	Warnings	Exact identifier application number: M018

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