Ear Ringing
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2011-03-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:04:02
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Ear Ringing Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.
DOSAGE & ADMINISTRATION SECTION
Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 6 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.
OTC - ACTIVE INGREDIENT SECTION
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, Hydrastis 3x.
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 dispensing alcohol 20%
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
OTC - 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.
OTC - 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 |
|---|---|---|---|---|---|
| 55714-2342-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-eb51-f424-e053-dadaa90a57ce | Ear Ringing |
| 55714-2342-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-eb51-f424-e053-dadaa90a57ce | Ear Ringing |
| 55714-2342-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-eb51-f424-e053-dadaa90a57ce | Ear Ringing |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-2342-0 | Ear Ringing | .5 mL in 1 BOTTLE, GLASS | LIQUID | .5 | 1 | |
| 55714-2342-1 | Ear Ringing | 29.57 mL in 1 BOTTLE, GLASS | LIQUID | 29.57 | 1 | |
| 55714-2342-2 | Ear Ringing | 59.14 mL in 1 BOTTLE, GLASS | LIQUID | 59.14 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-2342 | EAR 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, HYDRASTIS.) LIQUID [NEWTON LABORATORIES, INC.] | 1 | Legacy NDC, 3 package rows | 20121012_d5e0d2bb-65c3-5824-e9fe-3cf690f554bf.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 | |
| Alcohol | INACTIVE INGREDIENT | 3K9958V90M | 1 |
Products#
Every source-derived product name is available through these pages.
- Ear 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, Hydrastis.
- 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
- Alcohol
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-2342 | 55714-2342-1, 55714-2342-2, 55714-2342-0 |
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 |
| Goldenseal | ZW3Z11D0JV | ACTIB |
| Alcohol | 3K9958V90M | 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 |
|---|---|---|---|---|---|---|
| Alcohol | ALCOHOL | 3K9958V90M | SHAMPOO / TOPICAL | 714 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SWAB / TOPICAL | 2250 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SUSPENSION / ORAL | 681 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | CONCENTRATE / ORAL | 198 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / RECTAL | 898 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, FOAM / TOPICAL | 4504 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / ORAL | 150.68 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL, METERED / TRANSDERMAL | 3675 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / INTRAVENOUS | 4000 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAMUSCULAR | 1491 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / DENTAL | 1.8 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 35.75 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | POWDER, FOR SOLUTION / TOPICAL | 40 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / TRANSDERMAL | 49.37 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / INTRAVENOUS | 400 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | DROPS / NASAL | 10 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | TABLET, DELAYED RELEASE / ORAL | NA | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, METERED / NASAL | 70 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY, METERED / SUBLINGUAL | 29 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / SUBCUTANEOUS | 6.1 %v/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | PASTE / DENTAL | 1.8 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | ELIXIR / ORAL | 13675 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | DROPS / ORAL | 210 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / TOPICAL | 3633 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | JELLY / VAGINAL | NA | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / TOPICAL | 9971 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVENOUS | 99 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / TRANSDERMAL | 90 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / NASAL | 20 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / RESPIRATORY (INHALATION) | 5 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAVENOUS | 6405 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / ORAL | 6624 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | CONCENTRATE / BUCCAL | 679 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL, METERED / TOPICAL | 541 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVESICAL | 7892 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAVENOUS | 92 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / ORAL | 3563 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / TOPICAL | 561 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / TRANSDERMAL | 7360 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / SUBLINGUAL | 397 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / SUBCUTANEOUS | 149 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SUSPENSION / RECTAL | 0.35 %v/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, EMULSION / INTRAVENOUS | 520 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAMUSCULAR | 1000 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAVASCULAR | 100 %v/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, METERED / RESPIRATORY (INHALATION) | 26664 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LOTION / TOPICAL | 25 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL / NASAL | 20 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL / TOPICAL | 561 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | MOUTHWASH / BUCCAL | 200 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / DENTAL | 12.8 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / INTRAMUSCULAR | 400 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / NASAL | 10 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SYRUP / ORAL | 21000 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / RESPIRATORY (INHALATION) | 0.08 %w/v |
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 |
|---|---|---|---|---|---|---|
| 674d2f3e-0a8d-9991-cf13-03937246c079 | d5e0d2bb-65c3-5824-e9fe-3cf690f554bf | 2011-03-01 | Warnings | 674d2f3e-0a8d-9991-cf13-03937246c079 d5e0d2bb-65c3-5824-e9fe-3cf690f554bf |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
