Eyewash Station Additive Concentrate

Product NDC
78641-785
11-digit product format
786410785
Labeler code
78641
Product ID
78641-785_56b96cad-c6d1-3ad9-e063-6394a90ab92a
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorhexidine gluconate and Propylene Glycol
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
Global Equipment Company
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-05
Substance
CHLORHEXIDINE GLUCONATE; PROPYLENE GLYCOL
Active strength
145.6; 280 kg/2800L; kg/2800L
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78641-785-63IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78641-785-63IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78641-785-63IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage78641-785-63IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage78641-785-63UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage78641-785-63UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage78641-785-63UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
Eyewash Station Additive Concentrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE145.6 kg/2800L
PROPYLENE GLYCOL280 kg/2800L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MOR84MUD8EInternal UNII lookup
6DC9Q167V3Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bc93a1e8-aa3c-6735-e053-2995a90ad6e8Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78641-785-632025-01-30C16284748780-12cef2736-85cf-d83d-e063-dadaa90ab31fEYEWASH STATION ADDITIVE CONCENTRATE

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OptaseGLYCERINScope Health Incd81c1a4f-87b0-ee8c-e053-2995a90af9e52026-01-30WarningsExact identifier
application number: M018
OptaseGLYCERINScope Health Incf452a2c4-c869-7bf5-e053-2995a90ac1a02026-01-30WarningsExact identifier
application number: M018
Regener-Eyes Ophthalmic Solution LITE XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.47ab9609-4291-30b2-e063-6394a90a421e2026-01-29WarningsExact identifier
application number: M018
Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.48d6dc98-66e8-b499-e063-6394a90ae9352026-01-29WarningsExact identifier
application number: M018
OptaseGLYCERINScope Health Inc86c14327-ffc7-806e-e053-2991aa0aaf922026-01-29WarningsExact identifier
application number: M018
Regener-Eyes Ophthalmic Solution PROFESSIONALGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC49771efa-6682-51d0-e063-6294a90a18a52026-01-28WarningsExact identifier
application number: M018
Regener-Eyes Ophthalmic Solution LITEGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC497763ee-dc70-bb48-e063-6294a90afb3d2026-01-28WarningsExact identifier
application number: M018
Aurovisc Lubricant HYPROMELLOSE 2208 (15000 MPA.S) Gel/DropsHYPROMELLOSE OPHTHALMIC SOLUTION 2% W/VAurolabf27a6799-e2f1-ee8d-e053-2a95a90aead12026-01-27WarningsExact identifier
application number: M018
Carboxymethylcellulose Sodium Eye Drops 0.5%CARBOXYMETHYLCELLULOSE SODIUM EYE DROPS 0.5%Aurolabe8b4df3b-3d81-b3ca-e053-2a95a90af2ec2026-01-27WarningsExact identifier
application number: M018
Aurovisc OEHYPROMELLOSE OPHTHALMIC SOLUTION 2% W/VAurolab3142c6df-77ac-ec41-e063-6294a90aee472026-01-27WarningsExact identifier
application number: M018
AURO-CMCCARBOXYMETHYLCELLULOSE EYE DROPS 0.5%Aurolabe90b397f-fe64-8674-e053-2995a90a223f2026-01-27WarningsExact identifier
application number: M018
Optase AllegroHYDROXYETHYL CELLULOSEScope Health Incf7999928-f5c1-98d6-e053-6294a90a57db2026-01-27WarningsExact identifier
application number: M018
Family Care Single Use Lubricant Eye Drop 0.4mL 5ctCARBOXYMETHYLCELLULOSE SODIUMUnited Exchange Corp48879feb-b5ae-a9e6-e063-6394a90a03b22026-01-16WarningsExact identifier
application number: M018
Family Care Single Use Lubricant Eye Drop 0.4mL 30ctCARBOXYMETHYL CELLULOSE 0.5%United Exchange Corp488b3363-8d06-7dcc-e063-6294a90ab44c2026-01-16WarningsExact identifier
application number: M018
retaine PMMINERAL OIL, WHITE PETROLATUMOCuSOFT LLCac75e5c9-94ae-698d-40da-dffe4458a0982026-01-15WarningsExact identifier
application number: M018
Sodium Chloride HypertonicitySODIUM CHLORIDECVS Pharmacy9245d842-7f78-42d8-83ba-8eb9ec8dbc0d2026-01-15WarningsExact identifier
application number: M018
Sodium Chloride HypertonicitySODIUM CHLORIDECVS PHARMACYd5cc6cd1-ddf8-4f5b-a021-204cdda0db942026-01-15WarningsExact identifier
application number: M018
retaine MGDMINERAL OILOCuSOFT LLC06f57d46-96c7-4093-84aa-874ff4b2131d2026-01-15WarningsExact identifier
application number: M018
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
application number: M018
Vis Guard Lubricant EyeOintment PMMINERAL OIL, WHITE PETROLATUM OINTMENTUlai Health LLC1040a92b-d342-a9fd-e063-6294a90a45ef2026-01-13WarningsExact identifier
application number: M018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
78641-785-6378641078563.236 L in 1 BOTTLE, PLASTIC (78641-785-63) 2021-03-050000-00-00NoNoCurrent
78641-785-6778641078567.236 L in 1 BOTTLE, PLASTIC (78641-785-67) 2021-03-050000-00-00NoNoCurrent
78641-785-6878641078568.236 L in 1 BOTTLE, PLASTIC (78641-785-68) 2021-03-050000-00-00NoNoCurrent