FDA.reportPublic FDA data

Childrens Allergy Eye Relief

Product NDC
53799-370
Requested package NDC
53799-370-11
11-digit product format
537990370
Labeler code
53799
Product ID
53799-370_b6369156-0ed5-4ea0-aa6c-90ff030c3879
Type
HUMAN OTC DRUG
Nonproprietary name
ANEMONE PATENS, APIS MELLIFERA, EUPHRASIA STRICTA and SCHOENOCAULON OFFICINALE SEED
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Similasan AG
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-10-02
Marketing end
0000-00-00
Substance
APIS MELLIFERA; EUPHRASIA STRICTA; PULSATILLA PATENS WHOLE; SCHOENOCAULON OFFICINALE SEED
Active strength
6 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage53799-37053799-370-11IInactivated by FDA2026-10-12

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
53799-370-112023-01-30C16284748780-1f386c649-b351-0266-e053-dadaa90a7c1aChildrens Allergy Eye Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53799-370-11Childrens Allergy Eye Relief1 in 1 CARTONSOLUTION/ DROPS11
53799-370-11Childrens Allergy Eye Relief10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53799-370CHILDRENS ALLERGY EYE RELIEF (ANEMONE PATENS, APIS MELLIFERA, EUPHRASIA STRICTA AND SCHOENOCAULON OFFICINALE SEED) SOLUTION/ DROPS [SIMILASAN AG]1Legacy NDC, 2 package rows20201003_2137bba3-0efa-4490-b745-096dcd1ce1b0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53799-370-11537990370111 BOTTLE, DROPPER in 1 CARTON (53799-370-11) > 10 mL in 1 BOTTLE, DROPPER2020-10-020000-00-00NoNoCurrent