Tinnitus
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2011-06-01
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:05:11
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, Phosphorus, Pulsatilla Vulgaris, Salicylic Acid, Tobacco Leaf, Allylthiourea, Viola Odorata
Label structure10 sections
Contacts and useful links#
Websitewww.newtonlabs.net
www.newtonlabs.net
www.newtonlabs.netLabel contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Tinnitus 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 orally (ages 6 to 11, give 3 pellets) as needed or as directed by a healthcare professional.
ACTIVE INGREDIENT SECTION
Aconitum nap. 15x, Baryta carb. 15x, Baryta mur. 15x, Capsicum 15x, Causticum 15x, Chenopodium anthelminticum 15x, Chininum sulphuricum 15x, Cinchona 15x, Glonoinum 15x, Graphites 15x, Hydrastis 15x, Kali bic. 15x, Kali mur.15x, Lycopodium 15x, Phosphorus 15x, Pulsatilla 15x, Salicylicum ac.15x, Tabacum 15x, Thiosinaminum 15x, Viola odorata 15x, Hydrastis 8x, Hydrastis 3x.
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, beet-derived sucrose pellets.
QUESTIONS? SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256
WARNINGS SECTION
Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.
PREGNANCY OR BREAST FEEDING SECTION
Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.
KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
PACKAGE LABEL
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-4585-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b09e-f424-e053-dadaa90a57ce | Tinnitus |
| 55714-4585-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b09e-f424-e053-dadaa90a57ce | Tinnitus |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-4585-1 | Tinnitus | 28.35 g in 1 BOTTLE, GLASS | PELLET | 28.35 | 1 | |
| 55714-4585-2 | Tinnitus | 56.7 g in 1 BOTTLE, GLASS | PELLET | 56.7 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-4585 | TINNITUS (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.] | 1 | Legacy NDC, 2 package rows | 20131112_00f6bd07-e6a9-5e16-1a4a-e51c5901fd9e.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Aconitum Napellus | ACTIVE INGREDIENT | U0NQ8555JD | 1 | |
| Allylthiourea | ACTIVE INGREDIENT | 706IDJ14B7 | 1 | |
| Barium Carbonate | ACTIVE INGREDIENT | 6P669D8HQ8 | 1 | |
| Barium Chloride Dihydrate | ACTIVE INGREDIENT | EL5GJ3U77E | 1 | |
| Capsicum | ACTIVE INGREDIENT | 00UK7646FG | 1 | |
| Causticum | ACTIVE INGREDIENT | DD5FO1WKFU | 1 | |
| Cinchona Officinalis Bark | ACTIVE INGREDIENT | S003A158SB | 1 | |
| Dysphania Ambrosioides | ACTIVE INGREDIENT | 4H5RSU087I | 1 | |
| Goldenseal | ACTIVE INGREDIENT | ZW3Z11D0JV | 1 | |
| Graphite | ACTIVE INGREDIENT | 4QQN74LH4O | 1 | |
| Lycopodium Clavatum Spore | ACTIVE INGREDIENT | C88X29Y479 | 1 | |
| Nitroglycerin | ACTIVE INGREDIENT | G59M7S0WS3 | 1 | |
| Phosphorus | ACTIVE INGREDIENT | 27YLU75U4W | 1 | |
| Potassium Chloride | ACTIVE INGREDIENT | 660YQ98I10 | 1 | |
| Potassium Dichromate | ACTIVE INGREDIENT | T4423S18FM | 1 | |
| Pulsatilla Vulgaris | ACTIVE INGREDIENT | I76KB35JEV | 1 | |
| Quinine Sulfate | ACTIVE INGREDIENT | KF7Z0E0Q2B | 1 | |
| Salicylic Acid | ACTIVE INGREDIENT | O414PZ4LPZ | 1 | |
| Tobacco Leaf | ACTIVE INGREDIENT | 6YR2608RSU | 1 | |
| Viola Odorata | ACTIVE INGREDIENT | AET12U8B74 | 1 | |
| Aconitum Napellus | ACTIVE MOIETY | U0NQ8555JD | 1 | |
| Allylthiourea | ACTIVE MOIETY | 706IDJ14B7 | 1 | |
| Barium Cation | ACTIVE MOIETY | V645272HLN | 1 | |
| Capsicum | ACTIVE MOIETY | 00UK7646FG | 1 | |
| Causticum | ACTIVE MOIETY | DD5FO1WKFU | 1 | |
| Cinchona Officinalis Bark | ACTIVE MOIETY | S003A158SB | 1 | |
| Dichromate Ion | ACTIVE MOIETY | 9LKY4BFN2V | 1 | |
| Dysphania Ambrosioides | ACTIVE MOIETY | 4H5RSU087I | 1 | |
| Goldenseal | ACTIVE MOIETY | ZW3Z11D0JV | 1 | |
| Graphite | ACTIVE MOIETY | 4QQN74LH4O | 1 | |
| Lycopodium Clavatum Spore | ACTIVE MOIETY | C88X29Y479 | 1 | |
| Nitroglycerin | ACTIVE MOIETY | G59M7S0WS3 | 1 | |
| Phosphorus | ACTIVE MOIETY | 27YLU75U4W | 1 | |
| Potassium Cation | ACTIVE MOIETY | 295O53K152 | 1 | |
| Pulsatilla Vulgaris | ACTIVE MOIETY | I76KB35JEV | 1 | |
| Quinine | ACTIVE MOIETY | A7V27PHC7A | 1 | |
| Salicylic Acid | ACTIVE MOIETY | O414PZ4LPZ | 1 | |
| Tobacco Leaf | ACTIVE MOIETY | 6YR2608RSU | 1 | |
| Viola Odorata | ACTIVE MOIETY | AET12U8B74 | 1 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | 1 |
Products#
Every source-derived product name is available through these pages.
- Tinnitus
- 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
- Aconitum Napellus
- Barium Carbonate
- Barium Cation
- Barium Chloride Dihydrate
- Capsicum
- Causticum
- Dysphania Ambrosioides
- Quinine Sulfate
- Quinine
- Cinchona Officinalis Bark
- Nitroglycerin
- Graphite
- Goldenseal
- Potassium Dichromate
- Dichromate Ion
- Potassium Chloride
- Potassium Cation
- Lycopodium Clavatum Spore
- Phosphorus
- Pulsatilla Vulgaris
- Salicylic Acid
- Tobacco Leaf
- Allylthiourea
- Viola Odorata
- Sucrose
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-4585 | 55714-4585-1, 55714-4585-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Aconitum Napellus | U0NQ8555JD | ACTIB |
| Barium Carbonate | 6P669D8HQ8 | ACTIB |
| Barium Chloride Dihydrate | EL5GJ3U77E | ACTIB |
| Capsicum | 00UK7646FG | ACTIB |
| Causticum | DD5FO1WKFU | ACTIB |
| Dysphania Ambrosioides | 4H5RSU087I | ACTIB |
| Quinine Sulfate | KF7Z0E0Q2B | ACTIB |
| Cinchona Officinalis Bark | S003A158SB | ACTIB |
| Nitroglycerin | G59M7S0WS3 | ACTIB |
| Graphite | 4QQN74LH4O | ACTIB |
| Goldenseal | ZW3Z11D0JV | ACTIB |
| Potassium Dichromate | T4423S18FM | ACTIB |
| Potassium Chloride | 660YQ98I10 | ACTIB |
| Lycopodium Clavatum Spore | C88X29Y479 | ACTIB |
| Phosphorus | 27YLU75U4W | ACTIB |
| Pulsatilla Vulgaris | I76KB35JEV | ACTIB |
| Salicylic Acid | O414PZ4LPZ | ACTIB |
| Tobacco Leaf | 6YR2608RSU | ACTIB |
| Allylthiourea | 706IDJ14B7 | ACTIB |
| Viola Odorata | AET12U8B74 | ACTIB |
| Sucrose | C151H8M554 | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Sucrose | SUCROSE | C151H8M554 | TABLET, COATED / ORAL | 516.42 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUPPOSITORY / RECTAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / SUBLINGUAL | 109 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 86 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION / INTRAVENOUS | 1950 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| Sucrose | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / TRANSMUCOSAL | 1255 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, EMULSION / INTRAVENOUS | 970 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 900 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg | ||
| Sucrose | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED / ORAL | 145 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 9.4 %w/v | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 2000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 308 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| Sucrose | SUCROSE | C151H8M554 | TROCHE / BUCCAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 7560 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| Sucrose | SUCROSE | C151H8M554 | PASTILLE / ORAL | 426 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER, FOR SUSPENSION / ORAL | 40017 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 1 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2c8847e3-e129-6b7d-ff3e-832fd636f527 | 00f6bd07-e6a9-5e16-1a4a-e51c5901fd9e | 2011-06-01 | Warnings | 2c8847e3-e129-6b7d-ff3e-832fd636f527 00f6bd07-e6a9-5e16-1a4a-e51c5901fd9e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.