FDA.reportPublic FDA data

Ear Ringing

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-11-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:05:35

Label at a glance#

ProductEar Ringing
Active ingredientACONITUM NAPELLUS, BARIUM CARBONATE, BARIUM CHLORIDE DIHYDRATE, CAPSICUM, CAUSTICUM, DYSPHANIA AMBROSIOIDES, QUININE SULFATE, CINCHONA OFFICINALIS BARK, NITROGLYCERIN, GRAPHITE, GOLDENSEAL, POTASSIUM DICHROMATE, POTASSIUM CHLORIDE, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, PULSATILLA VULGARIS, SALICYLIC ACID, TOBACCO LEAF, ALLYLTHIOUREA, VIOLA ODORATA
Label structure8 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets by mouth (ages 6 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush or dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Htdrastis 6x, Aconitum nap. 10x, Baryta carb. 10x, Baryta mur. 10x, Capsicum 10x, Causticum 10x, Chenopodium anthelminticum 10x, Chininum sulphuricum 10x, Cinchona 10x, Glonoinum 10x, Graphites 10x, Hydrastis 10x, Kali bic. 10x, Kali mur.10x, Lycopodium 10x, Phosphorus 10x, Pulsatilla 10x, Salicylicum ac.10x, Tabacum 10x, Thiosinaminum 10x, Viola odorata 10x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net - Questions? 1.800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do no use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor.

If pregnant or breast-feeding, ask a doctor before use.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2427EAR RINGING (ACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATA) PELLET [NEWTON LABORATORIES, INC.]2Legacy NDC20201126_91adff14-2b9d-7b7d-e053-2a95a90a5e64.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-242755714-2427-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
ACONITUM NAPELLUSU0NQ8555JDACTIB
BARIUM CARBONATE6P669D8HQ8ACTIB
BARIUM CHLORIDE DIHYDRATEEL5GJ3U77EACTIB
CAPSICUM00UK7646FGACTIB
CAUSTICUMDD5FO1WKFUACTIB
DYSPHANIA AMBROSIOIDES4H5RSU087IACTIB
QUININE SULFATEKF7Z0E0Q2BACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
NITROGLYCERING59M7S0WS3ACTIB
GRAPHITE4QQN74LH4OACTIB
GOLDENSEALZW3Z11D0JVACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
POTASSIUM CHLORIDE660YQ98I10ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
PHOSPHORUS27YLU75U4WACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
SALICYLIC ACIDO414PZ4LPZACTIB
TOBACCO LEAF6YR2608RSUACTIB
ALLYLTHIOUREA706IDJ14B7ACTIB
VIOLA ODORATAAET12U8B74ACTIB

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3b17ffe0-3184-3e90-e063-6394a90aab5291adff14-2b9d-7b7d-e053-2a95a90a5e642025-07-29WarningsExact identifier
spl set id: 91adff14-2b9d-7b7d-e053-2a95a90a5e64

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.