Childrens Earache Relief

Product NDC
59262-274
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59262-274IInactivated by FDA2026-10-05
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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59262-274-11d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59262-274-11f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59262-274-112ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59262-274-11a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59262-274-11cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59262-274-11cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59262-274-11302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59262-274-11ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59262-274-110efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59262-274-11ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59262-274-11367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59262-274-11557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage59262-274-118af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage59262-274-11834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage59262-274-111332a3947898…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