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 12 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quality Choice Lubricant Eye Drops Long Lasting	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Chain Drug Marketing Assoc., Inc.	0cd91c45-88a2-f88c-e063-6294a90ad127	2025-12-30	Warnings	Exact identifier application number: M018
Quality Choice Eye Wash	WATER	Chain Drug Marketing Assoc., Inc.	1fb8a109-351b-7039-e063-6394a90a7311	2025-12-30	Warnings	Exact identifier application number: M018
Rite Aid Eye Wash	PURIFIED WATER	Rite Aid	28a18e04-d735-a511-e063-6394a90af6bb	2025-12-30	Warnings	Exact identifier application number: M018
Preferred Plus Pharmacy Redness Relief Eye Drops	TETRAHYDROZOLINE HCL	Kinray	9ffd67c4-b5c1-d587-e053-2a95a90ae3d0	2025-12-30	Warnings	Exact identifier application number: M018
Leader Lubricant Eye Drops Soothing Relief	CARBOXYMETHYLCELLULOSE SODIUM	LEADER/Cardinal Health 110, Inc.	218629d4-2704-a503-e063-6294a90a3953	2025-12-30	Warnings	Exact identifier application number: M018
Foster and Thrive Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Strategic Sourcing Services LLC	fb85ebc0-1570-972b-e053-6294a90a3dc4	2025-12-30	Warnings	Exact identifier application number: M018
Archies Dry Eye Relief	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Archie's Remedies	07da099b-6b7f-984d-e063-6294a90a12ac	2025-12-30	Warnings	Exact identifier application number: M018
Equate Optimal Hydration Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN	Walmart, Inc.	151b9723-5d5e-ac2b-e063-6294a90af073	2025-12-30	Warnings	Exact identifier application number: M018
Equate Nighttime Relief Lubricant	LIGHT MINERAL OIL, WHITE PETROLATUM	Walmart Inc.	152171db-2f2a-9d36-e063-6394a90a7225	2025-12-30	Warnings	Exact identifier application number: M018
Equate Moisturizing Comfort Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Walmart Inc.	152028bd-0429-720a-e063-6294a90a1465	2025-12-30	Warnings	Exact identifier application number: M018
Equaline Multi-Symptom Eye Drops	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	United Natural Foods, Inc.	fe467606-6d66-b695-e053-6294a90aab5d	2025-12-30	Warnings	Exact identifier application number: M018
OCUFRESH	WATER	Optics Laboratory Inc.	b8e477a9-66b9-496b-92fb-3d4bbd7b36b5	2025-12-29	Warnings	Exact identifier application number: M018
Kollourion Eyesalve Eyewash	PURIFIED WATER 98.3%	Miracle Eye Pharmaceuticals	b56d2ab9-169b-b490-e053-2a95a90a80b3	2025-12-28	Warnings	Exact identifier application number: M018
Equate Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN	Hanlim	46851e7c-8910-6456-e063-6394a90abafb	2025-12-22	Warnings	Exact identifier application number: M018
Equate Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Hanlim	46854996-a0b9-46b4-e063-6294a90aa433	2025-12-22	Warnings	Exact identifier application number: M018
Equate Nighttime Relief Lubricant	LIGHT MINERAL OIL, WHITE PETROLATUM	Hanlim Pharm Co. LTD	468559a0-9586-9982-e063-6394a90af466	2025-12-22	Warnings	Exact identifier application number: M018
Redness and Dry Eye Relief	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	KC Pharmaceuticals, Inc	4682f68d-6bdd-d860-e063-6394a90a2b52	2025-12-21	Warnings	Exact identifier application number: M018
Original Redness Reliever	TETRAHYDROLIZINE HCL	KC Pharmaceuticals	4683b850-b0fc-5093-e063-6294a90aef44	2025-12-21	Warnings	Exact identifier application number: M018
Equate Nighttime Relief Lubricant	LIGHT MINERAL OIL, WHITE PETROLATUM	Walmart	4449a55b-2cd4-0cb9-e063-6294a90aafbc	2025-12-20	Warnings	Exact identifier application number: M018
Equate Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Walmart	44494842-e38d-617c-e063-6294a90afaf8	2025-12-20	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