Xpect Buffered Eyewash Sterile Isotonic

Product NDC
42961-301
11-digit product format
429610301
Labeler code
42961
Product ID
42961-301_395f7efa-0850-45d5-ab11-37ecbfe4a73d
Type
HUMAN OTC DRUG
Nonproprietary name
Water
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Cintas Corporation
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-10-01
Marketing end
0000-00-00
Substance
WATER
Active strength
1 mL/mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42961-301DDiscontinued by firm2026-09-09
excluded packagepackage42961-30142961-301-20DDiscontinued by firm2026-09-09

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42961-301-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42961-301-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42961-301-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42961-301-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42961-301-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42961-301-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42961-301-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42961-301-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42961-301-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42961-301-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42961-301-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42961-301-20557ba5c1ecfa…9c80585c8c6e…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WaterACTIVE INGREDIENT059QF0KO0RXPECT BUFFERED EYEWASH STERILE ISOTONIC (WATER) SOLUTION [CINTAS]1
WaterACTIVE MOIETY059QF0KO0RXPECT BUFFERED EYEWASH STERILE ISOTONIC (WATER) SOLUTION [CINTAS]1
Benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7XPECT BUFFERED EYEWASH STERILE ISOTONIC (WATER) SOLUTION [CINTAS]1
Edetate disodiumINACTIVE INGREDIENT7FLD91C86KXPECT BUFFERED EYEWASH STERILE ISOTONIC (WATER) SOLUTION [CINTAS]1
Sodium chlorideINACTIVE INGREDIENT451W47IQ8XXPECT BUFFERED EYEWASH STERILE ISOTONIC (WATER) SOLUTION [CINTAS]1
Sodium phosphate, Dibasic, HeptahydrateINACTIVE INGREDIENT70WT22SF4BXPECT BUFFERED EYEWASH STERILE ISOTONIC (WATER) SOLUTION [CINTAS]1
Sodium phosphate, Monobasic, MonohydrateINACTIVE INGREDIENT593YOG76RNXPECT BUFFERED EYEWASH STERILE ISOTONIC (WATER) SOLUTION [CINTAS]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42961-301-20429610301204 BOTTLE, UNIT-DOSE in 1 BOX, UNIT-DOSE (42961-301-20) > 30 mL in 1 BOTTLE, UNIT-DOSE2011-10-010000-00-00NoNoCurrent