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 6 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Optase	GLYCERIN	Scope Health Inc	d81c1a4f-87b0-ee8c-e053-2995a90af9e5	2026-01-30	Warnings	Exact identifier application number: M018
Optase	GLYCERIN	Scope Health Inc	f452a2c4-c869-7bf5-e053-2995a90ac1a0	2026-01-30	Warnings	Exact identifier application number: M018
Regener-Eyes Ophthalmic Solution LITE XL	GLYCERIN OPHTHALMIC SOLUTION	M & M PRODUCTS, L.L.C.	47ab9609-4291-30b2-e063-6394a90a421e	2026-01-29	Warnings	Exact identifier application number: M018
Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XL	GLYCERIN OPHTHALMIC SOLUTION	M & M PRODUCTS, L.L.C.	48d6dc98-66e8-b499-e063-6394a90ae935	2026-01-29	Warnings	Exact identifier application number: M018
Optase	GLYCERIN	Scope Health Inc	86c14327-ffc7-806e-e053-2991aa0aaf92	2026-01-29	Warnings	Exact identifier application number: M018
Regener-Eyes Ophthalmic Solution PROFESSIONAL	GLYCERIN OPHTHALMIC SOLUTION	M & M PRODUCTS, LLC	49771efa-6682-51d0-e063-6294a90a18a5	2026-01-28	Warnings	Exact identifier application number: M018
Regener-Eyes Ophthalmic Solution LITE	GLYCERIN OPHTHALMIC SOLUTION	M & M PRODUCTS, LLC	497763ee-dc70-bb48-e063-6294a90afb3d	2026-01-28	Warnings	Exact identifier application number: M018
Aurovisc Lubricant HYPROMELLOSE 2208 (15000 MPA.S) Gel/Drops	HYPROMELLOSE OPHTHALMIC SOLUTION 2% W/V	Aurolab	f27a6799-e2f1-ee8d-e053-2a95a90aead1	2026-01-27	Warnings	Exact identifier application number: M018
Carboxymethylcellulose Sodium Eye Drops 0.5%	CARBOXYMETHYLCELLULOSE SODIUM EYE DROPS 0.5%	Aurolab	e8b4df3b-3d81-b3ca-e053-2a95a90af2ec	2026-01-27	Warnings	Exact identifier application number: M018
Aurovisc OE	HYPROMELLOSE OPHTHALMIC SOLUTION 2% W/V	Aurolab	3142c6df-77ac-ec41-e063-6294a90aee47	2026-01-27	Warnings	Exact identifier application number: M018
AURO-CMC	CARBOXYMETHYLCELLULOSE EYE DROPS 0.5%	Aurolab	e90b397f-fe64-8674-e053-2995a90a223f	2026-01-27	Warnings	Exact identifier application number: M018
Optase Allegro	HYDROXYETHYL CELLULOSE	Scope Health Inc	f7999928-f5c1-98d6-e053-6294a90a57db	2026-01-27	Warnings	Exact identifier application number: M018
Family Care Single Use Lubricant Eye Drop 0.4mL 5ct	CARBOXYMETHYLCELLULOSE SODIUM	United Exchange Corp	48879feb-b5ae-a9e6-e063-6394a90a03b2	2026-01-16	Warnings	Exact identifier application number: M018
Family Care Single Use Lubricant Eye Drop 0.4mL 30ct	CARBOXYMETHYL CELLULOSE 0.5%	United Exchange Corp	488b3363-8d06-7dcc-e063-6294a90ab44c	2026-01-16	Warnings	Exact identifier application number: M018
retaine PM	MINERAL OIL, WHITE PETROLATUM	OCuSOFT LLC	ac75e5c9-94ae-698d-40da-dffe4458a098	2026-01-15	Warnings	Exact identifier application number: M018
Sodium Chloride Hypertonicity	SODIUM CHLORIDE	CVS Pharmacy	9245d842-7f78-42d8-83ba-8eb9ec8dbc0d	2026-01-15	Warnings	Exact identifier application number: M018
Sodium Chloride Hypertonicity	SODIUM CHLORIDE	CVS PHARMACY	d5cc6cd1-ddf8-4f5b-a021-204cdda0db94	2026-01-15	Warnings	Exact identifier application number: M018
retaine MGD	MINERAL OIL	OCuSOFT LLC	06f57d46-96c7-4093-84aa-874ff4b2131d	2026-01-15	Warnings	Exact identifier application number: M018
Walgreens Sterile Soothing Eye Wash	PURIFIED WATER	Walgreens	a62e3294-abd6-48dc-81b1-62a809bdc968	2026-01-14	Warnings	Exact identifier application number: M018
Vis Guard Lubricant EyeOintment PM	MINERAL OIL, WHITE PETROLATUM OINTMENT	Ulai Health LLC	1040a92b-d342-a9fd-e063-6294a90a45ef	2026-01-13	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