FDA.reportPublic FDA data

Dry Eye Relief Trial Size 15x

Product NDC
53799-376
Requested package NDC
53799-376-13
11-digit product format
537990376
Labeler code
53799
Product ID
53799-376_a83108d4-24e4-490f-8f88-e30e854f7b57
Type
HUMAN OTC DRUG
Nonproprietary name
Belladonna, Euphrasia officinalis, Mercurius sublimatus,
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Similasan AG
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-07-08
Marketing end
0000-00-00
Substance
ATROPA BELLADONNA; EUPHRASIA STRICTA; MERCURIC CHLORIDE
Active strength
6 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL
NDC exclude flag
No
Listing certified through
2024-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53799-37653799-376-13IInactivated by FDA2026-10-05

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 1 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53799-376-132025-01-30C16284748780-12cef2736-5e46-d83d-e063-dadaa90ab31fDry Eye Relief Trial Size 15x

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53799-376-13Dry Eye Relief Trial Size 15x.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53799-376DRY EYE RELIEF TRIAL SIZE 15X (BELLADONNA, EUPHRASIA OFFICINALIS, MERCURIUS SUBLIMATUS,) SOLUTION/ DROPS [SIMILASAN AG]2Legacy NDC, 1 package rows20230106_26e39619-634c-42d2-92da-44e49df85f05.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53799-376-1353799037613.4 mL in 1 VIAL, SINGLE-USE (53799-376-13) 2021-07-080000-00-00NoNoCurrent