FDA.reportPublic FDA data

Childrens Earache Relief

Product NDC
53799-276
Requested package NDC
53799-276-11
11-digit product format
537990276
Labeler code
53799
Product ID
53799-276_5e1efbd7-706a-4393-95bc-3a122f1241ca
Type
HUMAN OTC DRUG
Nonproprietary name
CHAMOMILE, MERCURIUS SOLUBILIS, PULSATILLA PATENS WHOLE and SULFUR
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
Similasan AG
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-04-22
Marketing end
0000-00-00
Substance
CHAMOMILE; 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
2022-12-31
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 packagepackage53799-27653799-276-11IInactivated by FDA2026-10-16

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
53799-276-112023-01-30C16284748780-1f386c649-a118-0266-e053-dadaa90a7c1aChildrens Earache Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53799-276-11Childrens Earache Relief10 mL in 1 BOTTLE, DROPPERSOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53799-276CHILDRENS EARACHE RELIEF (CHAMOMILE, MERCURIUS SOLUBILIS, PULSATILLA PATENS WHOLE AND SULFUR) SOLUTION [SIMILASAN AG]1Legacy NDC, 1 package rows20210422_d6581b42-45d2-4b25-a902-85e952d08b49.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53799-276-115379902761110 mL in 1 BOTTLE, DROPPER (53799-276-11) 10 ml2021-04-220000-00-00NoNoCurrent