Home NDC 55714-1537-1 Ear Care
Product NDC 55714-1537
Requested package NDC 55714-1537-1
11-digit product format 557141537
Labeler code 55714
Product ID 55714-1537_da717cf0-54b0-c4e2-e053-2995a90ac97c
Type HUMAN OTC DRUG
Nonproprietary name Echinacea, Hydrastis canadensis, Apis mellifica, Arsenicum album, Belladonna, Bryonia, Capsicum annuum, Causticum, Cinchona officinalis, Conium maculatum, Dulcamara, Ferrum phosphoricum, Hepar sulphuris calcareum, Kali sulphuricum, Lycopodium clavatum, Mercurius vivus, Mezereum, Phosphorus, Plantago major, Pulsatilla, Silicea, Verbascum thapsus, Tellurium metallicum, Influenzinum
Dosage form LIQUID
Route ORAL
Labeler Newton Laboratories, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2022-03-07
Substance ANEMONE PULSATILLA; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CAPSICUM; CAUSTICUM; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DAPHNE MEZEREUM BARK; ECHINACEA, UNSPECIFIED; FERROSOFERRIC PHOSPHATE; GOLDENSEAL; INFLUENZA A VIRUS; INFLUENZA B VIRUS; LYCOPODIUM CLAVATUM SPORE; MERCURY; PHOSPHORUS; PLANTAGO MAJOR; POTASSIUM SULFATE; SILICON DIOXIDE; SOLANUM DULCAMARA TOP; TELLURIUM; VERBASCUM THAPSUS
Active strength 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 15; 6; 30; 30; 15; 15; 15; 15; 15; 15; 15; 16; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]
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 · 2 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 2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55714-1537 55714-1537-1 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 55714-1537 55714-1537-1 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base Ear Care
Listing expiration 2026-12-31
Active Ingredients# Ingredient, Strength table Ingredient Strength INFLUENZA B VIRUS 15 [hp_X]/mL ECHINACEA, UNSPECIFIED 15 [hp_X]/mL FERROSOFERRIC PHOSPHATE 15 [hp_X]/mL APIS MELLIFERA 15 [hp_X]/mL ARSENIC TRIOXIDE 15 [hp_X]/mL ATROPA BELLADONNA 15 [hp_X]/mL BRYONIA ALBA ROOT 15 [hp_X]/mL CAPSICUM 15 [hp_X]/mL CAUSTICUM 15 [hp_X]/mL CINCHONA OFFICINALIS BARK 15 [hp_X]/mL CONIUM MACULATUM FLOWERING TOP 15 [hp_X]/mL SOLANUM DULCAMARA TOP 6 [hp_X]/mL POTASSIUM SULFATE 15 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE 6 [hp_X]/mL MERCURY 30 [hp_X]/mL DAPHNE MEZEREUM BARK 30 [hp_X]/mL PHOSPHORUS 15 [hp_X]/mL SILICON DIOXIDE 15 [hp_X]/mL PLANTAGO MAJOR 15 [hp_X]/mL ANEMONE PULSATILLA 15 [hp_X]/mL TELLURIUM 15 [hp_X]/mL VERBASCUM THAPSUS 15 [hp_X]/mL INFLUENZA A VIRUS 15 [hp_X]/mL CALCIUM SULFIDE 16 [hp_X]/mL GOLDENSEAL 15 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 2 · 25 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55714-1537-1 Ear Care 30 mL in 1 BOTTLE, GLASS LIQUID 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55714-1537 EAR CARE (ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM) LIQUID [NEWTON LABORATORIES, INC.] 1 Current NDC, Legacy NDC, 1 package rows 20220319_da717cf0-54af-c4e2-e053-2995a90ac97c.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 Ear Care ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM Newton Laboratories, Inc. da717cf0-54af-c4e2-e053-2995a90ac97c 2022-03-17 Warnings Exact identifier ndc (package): 55714-1537-1 ndc (product): 55714-1537 ndc11 (package): 55714153701
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55714-1537-1 55714153701 30 mL in 1 BOTTLE, GLASS (55714-1537-1) 30 ml 2022-03-07 0000-00-00 No No Current