Home NDC 53799-500-11 Kids Allergy Eye Relief
Product NDC 53799-500
Requested package NDC 53799-500-11
11-digit product format 537990500
Labeler code 53799
Product ID 53799-500_1f82aafc-a51d-43f3-b456-a2e022c75fa2
Type HUMAN OTC DRUG
Nonproprietary name Apis and Euphrasia and Pulsatilla and Sabadilla
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Similasan AG
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2020-09-28
Marketing end 0000-00-00
Substance APIS MELLIFERA; EUPHRASIA STRICTA; PULSATILLA VULGARIS; SCHOENOCAULON OFFICINALE SEED
Active strength 6 [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL; [hp_X]/.45mL
Pharmacologic classes Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]
NDC exclude flag No
Listing certified through 2024-12-31
Current FDA listing Historical FDA.report record 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 date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53799-500-11 Kids Allergy Eye Relief 10 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 10 3 53799-500-11 Kids Allergy Eye Relief 1 in 1 BOX SOLUTION/ DROPS 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53799-500 KIDS ALLERGY EYE RELIEF (APIS AND EUPHRASIA AND PULSATILLA AND SABADILLA) SOLUTION/ DROPS [SIMILASAN AG] 3 Legacy NDC, 2 package rows 20230106_8a34c5d8-bda9-4fc1-967d-1117d9ecf80b.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 53799-500-11 53799050011 1 BOTTLE, DROPPER in 1 BOX (53799-500-11) > 10 mL in 1 BOTTLE, DROPPER 2020-09-28 0000-00-00 No No Current