FDA.reportPublic FDA data

Swimmers Ear Relief

Product NDC
59262-278
Requested package NDC
59262-278-11
11-digit product format
592620278
Labeler code
59262
Product ID
59262-278_9f99bd78-dea0-435f-aab3-06fe239195c9
Type
HUMAN OTC DRUG
Nonproprietary name
ANEMONE PULSATILLA, GRAPHITE and SULFUR
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
Similasan Corporation
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-12-15
Marketing end
0000-00-00
Substance
ANEMONE PULSATILLA; GRAPHITE; SULFUR
Active strength
12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
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 packagepackage59262-27859262-278-11IInactivated 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
59262-278-112025-01-30C16284748780-12cef2736-7e3a-d83d-e063-dadaa90ab31fSwimmers Ear Relief
59262-278-112025-01-30C16284748780-12cef2736-7e3a-d83d-e063-dadaa90ab31fSwimmers Ear Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59262-278-11Swimmers Ear Relief1 in 1 CARTONLIQUID12
59262-278-11Swimmers Ear Relief10 mL in 1 BOTTLE, DROPPERLIQUID102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59262-278SWIMMERS EAR RELIEF (ANEMONE PULSATILLA, GRAPHITE AND SULFUR) LIQUID [SIMILASAN CORPORATION]2Legacy NDC, 2 package rows20230106_df706641-4831-4dd9-b4cb-69c6edcc5863.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59262-278-11592620278111 BOTTLE, DROPPER in 1 CARTON (59262-278-11) > 10 mL in 1 BOTTLE, DROPPER2020-12-150000-00-00NoNoCurrent