FDA.reportPublic FDA data

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

Key Label Information#

Active Ingredients And Purpose

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.

Uses

INDICATIONS & USAGE SECTION

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

Warnings

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.

Directions And Dosage

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.

Other Label Information

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

PACKAGE LABEL

Label Images#

N077 L01-001-001
N077 L01-001-001

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
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bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
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419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
00358076-c817-430b-b924-11d717dc307cProduct name120160718
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0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2342-02020-01-31C16284748780-19d75b9d0-eb51-f424-e053-dadaa90a57ceEar Ringing
55714-2342-12020-01-31C16284748780-19d75b9d0-eb51-f424-e053-dadaa90a57ceEar Ringing
55714-2342-22020-01-31C16284748780-19d75b9d0-eb51-f424-e053-dadaa90a57ceEar Ringing

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2342-0Ear Ringing.5 mL in 1 BOTTLE, GLASSLIQUID.51
55714-2342-1Ear Ringing29.57 mL in 1 BOTTLE, GLASSLIQUID29.571
55714-2342-2Ear Ringing59.14 mL in 1 BOTTLE, GLASSLIQUID59.141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2342EAR 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.]1Legacy NDC, 3 package rows20121012_d5e0d2bb-65c3-5824-e9fe-3cf690f554bf.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aconitum NapellusACTIVE INGREDIENTU0NQ8555JD1
AllylthioureaACTIVE INGREDIENT706IDJ14B71
Barium CarbonateACTIVE INGREDIENT6P669D8HQ81
Barium Chloride DihydrateACTIVE INGREDIENTEL5GJ3U77E1
CapsicumACTIVE INGREDIENT00UK7646FG1
CausticumACTIVE INGREDIENTDD5FO1WKFU1
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB1
Dysphania AmbrosioidesACTIVE INGREDIENT4H5RSU087I1
GoldensealACTIVE INGREDIENTZW3Z11D0JV1
GraphiteACTIVE INGREDIENT4QQN74LH4O1
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4791
NitroglycerinACTIVE INGREDIENTG59M7S0WS31
PhosphorusACTIVE INGREDIENT27YLU75U4W1
Potassium ChlorideACTIVE INGREDIENT660YQ98I101
Potassium DichromateACTIVE INGREDIENTT4423S18FM1
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV1
Quinine SulfateACTIVE INGREDIENTKF7Z0E0Q2B1
Salicylic AcidACTIVE INGREDIENTO414PZ4LPZ1
Tobacco LeafACTIVE INGREDIENT6YR2608RSU1
Viola OdorataACTIVE INGREDIENTAET12U8B741
Aconitum NapellusACTIVE MOIETYU0NQ8555JD1
AllylthioureaACTIVE MOIETY706IDJ14B71
Barium CationACTIVE MOIETYV645272HLN1
CapsicumACTIVE MOIETY00UK7646FG1
CausticumACTIVE MOIETYDD5FO1WKFU1
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB1
Dichromate IonACTIVE MOIETY9LKY4BFN2V1
Dysphania AmbrosioidesACTIVE MOIETY4H5RSU087I1
GoldensealACTIVE MOIETYZW3Z11D0JV1
GraphiteACTIVE MOIETY4QQN74LH4O1
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4791
NitroglycerinACTIVE MOIETYG59M7S0WS31
PhosphorusACTIVE MOIETY27YLU75U4W1
Potassium CationACTIVE MOIETY295O53K1521
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV1
QuinineACTIVE MOIETYA7V27PHC7A1
Salicylic AcidACTIVE MOIETYO414PZ4LPZ1
Tobacco LeafACTIVE MOIETY6YR2608RSU1
Viola OdorataACTIVE MOIETYAET12U8B741
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-234255714-2342-1, 55714-2342-2, 55714-2342-0

Ingredients#

Name, UNII, Kind table
NameUNIIKind
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
GoldensealZW3Z11D0JVACTIB
Alcohol3K9958V90MIACT

Complete SPL Sections#

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

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

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012 Questions? 1.800.448.7256

WARNINGS SECTION

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

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML