Earache Relief

Product NDC
53799-277
11-digit product format
537990277
Labeler code
53799
Product ID
53799-277_7b40fe63-4595-4977-8a66-853b0598e58d
Type
HUMAN OTC DRUG
Nonproprietary name
Chamomilla and Mercurius Solubilis and Sulphur
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
Similasan AG
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-07-02
Substance
CHAMOMILE; MERCURIUS SOLUBILIS; SULFUR
Active strength
10; 15; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Earache Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHAMOMILE10 [hp_X]/10mL
MERCURIUS SOLUBILIS15 [hp_X]/10mL
SULFUR12 [hp_X]/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFGL3685T2X, 324Y4038G2, 70FD1KFU70

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53799-277-112025-02-25C16284748780-12cef2736-9c27-d83d-e063-dadaa90ab31fEarache Relief
53799-277-112025-01-30C16284748780-12cef2736-9c27-d83d-e063-dadaa90ab31fEarache Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53799-277-11Earache Relief10 mL in 1 BOTTLE, GLASSSOLUTION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53799-277EARACHE RELIEF (CHAMOMILLA AND MERCURIUS SOLUBILIS AND SULPHUR) SOLUTION [SIMILASAN AG]6Current NDC, Legacy NDC, 1 package rows20250227_b9749db9-a2e4-4460-8769-6150285a7413.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53799-277-115379902771110 mL in 1 BOTTLE, GLASS (53799-277-11) 10 ml2013-07-020000-00-00NoNoCurrent