Home NDC 43689-0020 Earache Relief
Product NDC 43689-0020
11-digit product format 436890020
Labeler code 43689
Product ID 43689-0020_32934d7c-c3dc-4bfc-8b8c-ffbbc39768de
Type HUMAN OTC DRUG
Nonproprietary name Belladonna, Calcarea Carbonica, Chamomilla, Hepar Sulphuris Calcareum, Kali Bichromicum, Lycopodium Clavatum, Plantago Major, Pulsatilla (Vulgaris)
Dosage form TABLET
Route ORAL
Labeler The Magni Company
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2016-05-09
Substance ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA CHAMOMILLA WHOLE; CALCIUM SULFIDE; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; PLANTAGO MAJOR WHOLE; PULSATILLA VULGARIS WHOLE
Active strength 12; 12; 12; 12; 12; 12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 43689-0020-2 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 43689-0020-2 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 43689-0020-2 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 43689-0020-2 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 43689-0020-2 1332a3947898…d4bfe170f9cd…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 43689-0020-2 8dfbde2a14a4…c9ff85d89658…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Earache Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATROPA BELLADONNA 12 [hp_X]/1 OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X]/1 MATRICARIA CHAMOMILLA WHOLE 12 [hp_X]/1 CALCIUM SULFIDE 12 [hp_X]/1 POTASSIUM DICHROMATE 12 [hp_X]/1 LYCOPODIUM CLAVATUM SPORE 12 [hp_X]/1 PLANTAGO MAJOR WHOLE 12 [hp_X]/1 PULSATILLA VULGARIS WHOLE 12 [hp_X]/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 8 matching rows.
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 43689-0020-1 Earache Relief 90 in 1 BOTTLE TABLET 90 4 43689-0020-2 Earache Relief 1 in 1 PACKAGE TABLET 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43689-0020 EARACHE RELIEF (BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PLANTAGO MAJOR, PULSATILLA (VULGARIS)) TABLET [THE MAGNI COMPANY] 4 Current NDC, Legacy NDC, 2 package rows 20241107_3f62001a-27b5-43cb-8006-110943facf87.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Earache Relief BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PLANTAGO MAJOR, PULSATILLA (VULGARIS) The Magni Company 3f62001a-27b5-43cb-8006-110943facf87 2024-11-05 Warnings Exact identifier ndc (product): 43689-0020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43689-0020-1 43689002001 90 in 1 BOTTLE Historical 43689-0020-2 43689002002 1 BOTTLE in 1 PACKAGE (43689-0020-2) / 90 TABLET in 1 BOTTLE (43689-0020-1) 1 bottle 2016-08-24 0000-00-00 No No Current