Sperian Eyesaline Eyewash

Product NDC: 64809-101
11-digit product format: 648090101
Labeler code: 64809
Product ID: 64809-101_9ed6165e-5e85-4320-8dcb-5d6798a4283d
Type: HUMAN OTC DRUG
Nonproprietary name: Water
Dosage form: LIQUID
Route: OPHTHALMIC
Labeler: Sperian Eye & Face Protection Inc
Application: part349
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-09-07
Marketing end: 0000-00-00
Substance: WATER
Active strength: 100 mL/100mL
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64809-101		I	Inactivated by FDA	2026-10-05
excluded package	package	64809-101	64809-101-12	I	Inactivated by FDA	2026-10-05
excluded package	package	64809-101	64809-101-13	I	Inactivated by FDA	2026-10-05
excluded package	package	64809-101	64809-101-14	I	Inactivated by FDA	2026-10-05
excluded package	package	64809-101	64809-101-15	I	Inactivated by FDA	2026-10-05
excluded package	package	64809-101	64809-101-16	I	Inactivated by FDA	2026-10-05
excluded package	package	64809-101	64809-101-21	I	Inactivated by FDA	2026-10-05

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 3 · 154 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	64809-101-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64809-101-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64809-101-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64809-101-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64809-101-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64809-101-12	`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	64809-101-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64809-101-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64809-101-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64809-101-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64809-101-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64809-101-12	`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	64809-101-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64809-101-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64809-101-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64809-101-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64809-101-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64809-101-12	`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	64809-101-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64809-101-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64809-101-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64809-101-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64809-101-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64809-101-12	`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	64809-101-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64809-101-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64809-101-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64809-101-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64809-101-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64809-101-12	`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	64809-101-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64809-101-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64809-101-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64809-101-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64809-101-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64809-101-12	`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	64809-101-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64809-101-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64809-101-13	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64809-101-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64809-101-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64809-101-12	`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	64809-101-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64809-101-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64809-101-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64809-101-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64809-101-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64809-101-12	`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	64809-101-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64809-101-21	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64809-101-13	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
64809-101-12	Sperian Eyesaline Eyewash
64809-101-13	Sperian Eyesaline Eyewash
64809-101-14	Sperian Eyesaline Eyewash
64809-101-15	Sperian Eyesaline Eyewash
64809-101-16	Sperian Eyesaline Eyewash
64809-101-21	Sperian Eyesaline Eyewash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64809-101-12	Sperian Eyesaline Eyewash	30 mL in 1 BOTTLE, PLASTIC	LIQUID	30		2
64809-101-13	Sperian Eyesaline Eyewash	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118		2
64809-101-14	Sperian Eyesaline Eyewash	237 mL in 1 BOTTLE, PLASTIC	LIQUID	237		2
64809-101-15	Sperian Eyesaline Eyewash	473 mL in 1 BOTTLE, PLASTIC	LIQUID	473		2
64809-101-16	Sperian Eyesaline Eyewash	946 mL in 1 BOTTLE, PLASTIC	LIQUID	946		2
64809-101-16	Prinzing Eye Wash Station	1892 mL in 1 BOTTLE, PLASTIC	LIQUID	946 mL	99.8 mL in 100mL	2
64809-101-21	Sperian Eyesaline Eyewash	15 mL in 1 BOTTLE, PLASTIC	LIQUID	15		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
WATER	ACTIVE INGREDIENT	059QF0KO0R	PRINZING EYE WASH STATION () KIT [BRADY MEXICO, S. DE R.L. DE C.V.]	2
WATER	ACTIVE INGREDIENT	059QF0KO0R	SPERIAN EYESALINE EYEWASH (WATER) LIQUID [SPERIAN EYE & FACE PROTECTION INC]	2
WATER	ACTIVE MOIETY	059QF0KO0R	PRINZING EYE WASH STATION () KIT [BRADY MEXICO, S. DE R.L. DE C.V.]	2
WATER	ACTIVE MOIETY	059QF0KO0R	SPERIAN EYESALINE EYEWASH (WATER) LIQUID [SPERIAN EYE & FACE PROTECTION INC]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	PRINZING EYE WASH STATION () KIT [BRADY MEXICO, S. DE R.L. DE C.V.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	SPERIAN EYESALINE EYEWASH (WATER) LIQUID [SPERIAN EYE & FACE PROTECTION INC]	2
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	INACTIVE INGREDIENT	22ADO53M6F	PRINZING EYE WASH STATION () KIT [BRADY MEXICO, S. DE R.L. DE C.V.]	2
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	INACTIVE INGREDIENT	22ADO53M6F	SPERIAN EYESALINE EYEWASH (WATER) LIQUID [SPERIAN EYE & FACE PROTECTION INC]	2
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	INACTIVE INGREDIENT	593YOG76RN	PRINZING EYE WASH STATION () KIT [BRADY MEXICO, S. DE R.L. DE C.V.]	2
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	INACTIVE INGREDIENT	593YOG76RN	SPERIAN EYESALINE EYEWASH (WATER) LIQUID [SPERIAN EYE & FACE PROTECTION INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64809-101	PRINZING EYE WASH STATION () KIT [BRADY MEXICO, S. DE R.L. DE C.V.]	2	Legacy NDC	20140624_2742ce51-0e2e-41c9-86f8-66ab2fb23e41.zip
64809-101	SPERIAN EYESALINE EYEWASH (WATER) LIQUID [SPERIAN EYE & FACE PROTECTION INC]	2	Legacy NDC, 6 package rows	20110909_f3b2ad2c-cb37-422a-95a1-c49709f4fe01.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
059QF0KO0R	WATER	7732-18-5	WATER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1150126	water 99.8 % Ophthalmic Irrigation Solution	PSN	2742ce51-0e2e-41c9-86f8-66ab2fb23e41	2
1150126	water 99.8 % Ophthalmic Irrigation Solution	PSN	f3b2ad2c-cb37-422a-95a1-c49709f4fe01	2
1150126	water 998 MG/ML Ophthalmic Irrigation Solution	SCD	2742ce51-0e2e-41c9-86f8-66ab2fb23e41	2
1150126	water 998 MG/ML Ophthalmic Irrigation Solution	SCD	f3b2ad2c-cb37-422a-95a1-c49709f4fe01	2
1150126	water 99.8 % Ophthalmic Irrigation Solution	SY	2742ce51-0e2e-41c9-86f8-66ab2fb23e41	2
1150126	water 99.8 % Ophthalmic Irrigation Solution	SY	f3b2ad2c-cb37-422a-95a1-c49709f4fe01	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
64809-101-12	64809010112	30 mL in 1 BOTTLE, PLASTIC	30 ml	Historical
64809-101-13	64809010113	118 mL in 1 BOTTLE, PLASTIC	118 ml	Historical
64809-101-14	64809010114	237 mL in 1 BOTTLE, PLASTIC	237 ml	Historical
64809-101-15	64809010115	473 mL in 1 BOTTLE, PLASTIC	473 ml	Historical
64809-101-16	64809010116	946 mL in 1 BOTTLE, PLASTIC	946 ml	Historical
64809-101-21	64809010121	15 mL in 1 BOTTLE, PLASTIC	15 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prinzing Eyewash Station	BRADY MEXICO, S. DE R.L. DE C.V. \| Sperian Eye & Face Protection Inc	2014-06-24	MEDICAL DEVICE	2
Sperian Eyesaline Eyewash	Sperian Eye & Face Protection Inc \| Medex Cardio Pulmonary dba Smiths Medical	2011-09-07	HUMAN OTC DRUG LABEL	2