FDA.reportPublic FDA data

Tinnitus

Manufacturer
Newton Laboratories, Inc.
Effective date
2024-01-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:25:58

Label at a glance#

ProductTinnitus
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, ANEMONE PULSATILLA, SALICYLIC ACID, TOBACCO LEAF, ALLYLTHIOUREA, VIOLA ODORATA, PHOSPHORUS
Label structure10 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 drops by mouth (ages 6 to 11, give 3 drops) as needed or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Hydrastis canadensis 11x, Aconitum napellus 20x, Baryta carbonica 20x, Baryta muriatica 20x, Capsicum annuum 20x, Causticum 20x, Chenopodium anthelminticum 20x, Chininum sulphuricum 20x, Cinchona officinalis 20x, Glonoinum 20x, Graphites 20x, Hydrastis canadensis 20x, Kali bichromicum 20x, Kali muriaticum 20x, Lycopodium clavatum 20x, Phosphorus 20x, Pulsatilla 20x, Salicylicum acidum 20x, Tabacum 20x, Thiosinaminum 20x, Viola odorata 20x.

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net -Questions? 800.448.7256

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

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

WARNINGS: Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4857-1Tinnitus30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4857TINNITUS (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) LIQUID [NEWTON LABORATORIES, INC.]1Current NDC, 1 package rows20240202_10462aaa-96d4-4ba3-e063-6294a90a7915.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-485755714-4857-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
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
ANEMONE PULSATILLAI76KB35JEVACTIB
SALICYLIC ACIDO414PZ4LPZACTIB
TOBACCO LEAF6YR2608RSUACTIB
ALLYLTHIOUREA706IDJ14B7ACTIB
VIOLA ODORATAAET12U8B74ACTIB
WATER059QF0KO0RIACT
PHOSPHORUS27YLU75U4WACTIB

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
TinnitusACONITUM 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 ODORATANewton Laboratories, Inc.10462aaa-96d4-4ba3-e063-6294a90a79152024-01-31WarningsExact identifier
ndc (package): 55714-4857-1
ndc (product): 55714-4857
ndc11 (package): 55714485701
spl id: 10462abf-9261-c0fe-e063-6394a90a7a71
spl set id: 10462aaa-96d4-4ba3-e063-6294a90a7915

Reported adverse events (FAERS/openFDA)#

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