Home NDC 53799-277-11 Earache Relief
Product NDC 53799-277
Requested package NDC 53799-277-11
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 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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53799-277 53799-277-11 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53799-277 53799-277-11 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53799-277 53799-277-11 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base Earache Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHAMOMILE 10 [hp_X]/10mL MERCURIUS SOLUBILIS 15 [hp_X]/10mL SULFUR 12 [hp_X]/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FGL3685T2X Internal UNII lookup 324Y4038G2 Internal UNII lookup 70FD1KFU70 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53799-277-11 Earache Relief 10 mL in 1 BOTTLE, GLASS SOLUTION 10 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53799-277 EARACHE RELIEF (CHAMOMILLA AND MERCURIUS SOLUBILIS AND SULPHUR) SOLUTION [SIMILASAN AG] 6 Current NDC, Legacy NDC, 1 package rows 20250227_b9749db9-a2e4-4460-8769-6150285a7413.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53799-277-11 53799027711 10 mL in 1 BOTTLE, GLASS (53799-277-11) 10 ml 2013-07-02 0000-00-00 No No Current