FDA.reportPublic FDA data

Kids Earache Relief

Product NDC
53799-279
Requested package NDC
53799-279-11
11-digit product format
537990279
Labeler code
53799
Product ID
53799-279_17164dc7-5682-4275-9b5a-a3c00cbac91b
Type
HUMAN OTC DRUG
Nonproprietary name
Matricaria recutita, Mercurius Solubilis, Anemone patens and Sulphur
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
Similasan AG
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-07-20
Marketing end
0000-00-00
Substance
MATRICARIA CHAMOMILLA; MERCURIUS SOLUBILIS; PULSATILLA PATENS WHOLE; SULFUR
Active strength
10 [hp_X]/10mL; [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 packagepackage53799-27953799-279-11IInactivated 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
53799-279-112025-01-30C16284748780-12cef2736-8362-d83d-e063-dadaa90ab31fKids Earache Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53799-279-11Kids Earache Relief10 mL in 1 BOTTLE, DROPPERSOLUTION103
53799-279-11Kids Earache Relief1 in 1 BOXSOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53799-279KIDS EARACHE RELIEF (MATRICARIA RECUTITA, MERCURIUS SOLUBILIS, ANEMONE PATENS AND SULPHUR) SOLUTION [SIMILASAN AG]3Legacy NDC, 2 package rows20230106_8964865b-b9bb-4591-bd22-635ec0e2b13c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53799-279-11537990279111 BOTTLE, DROPPER in 1 BOX (53799-279-11) > 10 mL in 1 BOTTLE, DROPPER2018-07-200000-00-00NoNoCurrent