FDA.reportPublic FDA data

Childrens Earache Relief

Product NDC
59262-274
Requested package NDC
59262-274-11
11-digit product format
592620274
Labeler code
59262
Product ID
59262-274_7b31b0e7-ff51-4b0f-8ee0-aa78e6d676d0
Type
HUMAN OTC DRUG
Nonproprietary name
Chamomilla 10X, Mercurius solubilis 15X, Pulsatilla 12X, Sulphur 12X
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
Similasan Corporation
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2007-01-01
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 packagepackage59262-27459262-274-11IInactivated 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 · 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
59262-274-112023-01-30C16284748780-1ba0f9c33-2f3a-a910-e053-dadaa90a0b85Childrens Earache Relief
59262-274-112021-04-20C16284748780-1ba0f9c33-2f3a-a910-e053-dadaa90a0b85Childrens Earache Relief
59262-274-112021-01-29C16284748780-1ba0f9c33-2f3a-a910-e053-dadaa90a0b85Childrens Earache Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59262-274-11Childrens Earache Relief10 mL in 1 BOTTLE, DROPPERSOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59262-274-11ML - Milliliter59262-2742b944d47-b384-4846-8375-0dc56fef153112015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHAMOMILEACTIVE INGREDIENTFGL3685T2XCHILDRENS EARACHE RELIEF (CHAMOMILLA 10X, MERCURIUS SOLUBILIS 15X, PULSATILLA 12X, SULPHUR 12X) SOLUTION [SIMILASAN CORPORATION]1
MERCURIUS SOLUBILISACTIVE INGREDIENT324Y4038G2CHILDRENS EARACHE RELIEF (CHAMOMILLA 10X, MERCURIUS SOLUBILIS 15X, PULSATILLA 12X, SULPHUR 12X) SOLUTION [SIMILASAN CORPORATION]1
PULSATILLA PATENSACTIVE INGREDIENT4M1169RWJDCHILDRENS EARACHE RELIEF (CHAMOMILLA 10X, MERCURIUS SOLUBILIS 15X, PULSATILLA 12X, SULPHUR 12X) SOLUTION [SIMILASAN CORPORATION]1
SULFURACTIVE INGREDIENT70FD1KFU70CHILDRENS EARACHE RELIEF (CHAMOMILLA 10X, MERCURIUS SOLUBILIS 15X, PULSATILLA 12X, SULPHUR 12X) SOLUTION [SIMILASAN CORPORATION]1
CHAMOMILEACTIVE MOIETYFGL3685T2XCHILDRENS EARACHE RELIEF (CHAMOMILLA 10X, MERCURIUS SOLUBILIS 15X, PULSATILLA 12X, SULPHUR 12X) SOLUTION [SIMILASAN CORPORATION]1
MERCURIUS SOLUBILISACTIVE MOIETY324Y4038G2CHILDRENS EARACHE RELIEF (CHAMOMILLA 10X, MERCURIUS SOLUBILIS 15X, PULSATILLA 12X, SULPHUR 12X) SOLUTION [SIMILASAN CORPORATION]1
PULSATILLA PATENSACTIVE MOIETY4M1169RWJDCHILDRENS EARACHE RELIEF (CHAMOMILLA 10X, MERCURIUS SOLUBILIS 15X, PULSATILLA 12X, SULPHUR 12X) SOLUTION [SIMILASAN CORPORATION]1
SULFURACTIVE MOIETY70FD1KFU70CHILDRENS EARACHE RELIEF (CHAMOMILLA 10X, MERCURIUS SOLUBILIS 15X, PULSATILLA 12X, SULPHUR 12X) SOLUTION [SIMILASAN CORPORATION]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS EARACHE RELIEF (CHAMOMILLA 10X, MERCURIUS SOLUBILIS 15X, PULSATILLA 12X, SULPHUR 12X) SOLUTION [SIMILASAN CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59262-274CHILDRENS EARACHE RELIEF (CHAMOMILLA 10X, MERCURIUS SOLUBILIS 15X, PULSATILLA 12X, SULPHUR 12X) SOLUTION [SIMILASAN CORPORATION]3Legacy NDC, 1 package rows20210421_47258c11-ddd8-4ce1-83a4-6fb5295c73aa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59262-274-115926202741110 mL in 1 BOTTLE, DROPPER (59262-274-11) 10 ml2007-01-010000-00-00NoNoCurrent