FDA.reportPublic FDA data

Ear Care

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:05:26

Label at a glance#

ProductEar Care
Active ingredientInfluenza A Virus, Tellurium, Apis Mellifera, Arsenic Trioxide, Atropa Belladonna, Bryonia Alba Root, Capsicum, Causticum, Cinchona Officinalis Bark, Conium Maculatum Flowering Top, Solanum Dulcamara Stem, Ferrosoferric Phosphate, Calcium Sulfide, Potassium Sulfate, Lycopodium Clavatum Spore, Mercury, Daphne Mezereum Bark, Phosphorus, Plantago Major, Pulsatilla Vulgaris, Silicon Dioxide, Verbascum Thapsus, Echinacea, Unspecified, Goldenseal, Influenza B Virus
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

EAR CARE    Formulated for symptoms associated with Meniere's disease, mastoiditis, otitis, otorrhea and other related ear conditions.   

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops ) one to four times daily or as directed by a healthcare professional. 

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Influenzinum 30x, Tellurium metallicum 15x, Apis mel. 10x, Arsenicum alb. 10x, Belladonna 10x, Bryonia 10x, Capsicum 10x, Causticum 10x, Cinchona 10x, Conium 10x, Dulcamara 10x, Ferrum phosphoricum 10x, Hepar sulph. calc. 10x, Kali sulph. 10x, Lycopodium 10x, Merc. viv. 10x, Mezereum 10x, Phosphorus 10x, Plantago 10x, Pulsatilla 10x, Silicea 10x, Verbascum 10x, Echinacea 3x, Hydrastis 3x.           

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

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

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      

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

Package Label
Package Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-4416-12020-01-31C16284748780-19d75b9cf-f1ac-f424-e053-dadaa90a57ceEar Care
55714-4416-22020-01-31C16284748780-19d75b9cf-f1ac-f424-e053-dadaa90a57ceEar Care

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4416-1Ear Care29.57 mL in 1 BOTTLE, GLASSLIQUID29.573
55714-4416-2Ear Care59.14 mL in 1 BOTTLE, GLASSLIQUID59.143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4416EAR CARE (INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL, ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC., KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS) LIQUID [NEWTON LABORATORIES, INC.]3Legacy NDC, 2 package rows20140206_e7c5d1e7-8f0b-bb84-9e95-d41af27bdf52.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Apis MelliferaACTIVE INGREDIENT7S82P3R43Z3
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO3
Atropa BelladonnaACTIVE INGREDIENTWQZ3G9PF0H3
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B3
Calcium SulfideACTIVE INGREDIENT1MBW07J51Q3
CapsicumACTIVE INGREDIENT00UK7646FG3
CausticumACTIVE INGREDIENTDD5FO1WKFU3
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB3
Conium Maculatum Flowering TopACTIVE INGREDIENTQ28R5GF3713
Daphne Mezereum BarkACTIVE INGREDIENTX2N6E405GV3
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX3
Ferrosoferric PhosphateACTIVE INGREDIENT91GQH8I5F73
GoldensealACTIVE INGREDIENTZW3Z11D0JV3
Influenza A VirusACTIVE INGREDIENTR9HH0NDE2E3
Influenza B VirusACTIVE INGREDIENT1314JZ2X6W3
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4793
MercuryACTIVE INGREDIENTFXS1BY2PGL3
PhosphorusACTIVE INGREDIENT27YLU75U4W3
Plantago MajorACTIVE INGREDIENTW2469WNO6U3
Potassium SulfateACTIVE INGREDIENT1K573LC5TV3
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV3
Silicon DioxideACTIVE INGREDIENTETJ7Z6XBU43
Solanum Dulcamara StemACTIVE INGREDIENTIR986LE7DF3
TelluriumACTIVE INGREDIENTNQA0O090ZJ3
Verbascum ThapsusACTIVE INGREDIENTC9TD27U1723
Apis MelliferaACTIVE MOIETY7S82P3R43Z3
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV3
Atropa BelladonnaACTIVE MOIETYWQZ3G9PF0H3
Bryonia Alba RootACTIVE MOIETYT7J046YI2B3
Calcium SulfideACTIVE MOIETY1MBW07J51Q3
CapsicumACTIVE MOIETY00UK7646FG3
CausticumACTIVE MOIETYDD5FO1WKFU3
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB3
Conium Maculatum Flowering TopACTIVE MOIETYQ28R5GF3713
Daphne Mezereum BarkACTIVE MOIETYX2N6E405GV3
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX3
Ferrosoferric PhosphateACTIVE MOIETY91GQH8I5F73
GoldensealACTIVE MOIETYZW3Z11D0JV3
Influenza A VirusACTIVE MOIETYR9HH0NDE2E3
Influenza B VirusACTIVE MOIETY1314JZ2X6W3
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4793
MercuryACTIVE MOIETYFXS1BY2PGL3
PhosphorusACTIVE MOIETY27YLU75U4W3
Plantago MajorACTIVE MOIETYW2469WNO6U3
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV3
Silicon DioxideACTIVE MOIETYETJ7Z6XBU43
Solanum Dulcamara StemACTIVE MOIETYIR986LE7DF3
Sulfate IonACTIVE MOIETY7IS9N8KPMG3
TelluriumACTIVE MOIETYNQA0O090ZJ3
Verbascum ThapsusACTIVE MOIETYC9TD27U1723
AlcoholINACTIVE INGREDIENT3K9958V90M3

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-441655714-4416-1, 55714-4416-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
Influenza A VirusR9HH0NDE2EACTIB
TelluriumNQA0O090ZJACTIB
Apis Mellifera7S82P3R43ZACTIB
Arsenic TrioxideS7V92P67HOACTIB
Atropa BelladonnaWQZ3G9PF0HACTIB
Bryonia Alba RootT7J046YI2BACTIB
Capsicum00UK7646FGACTIB
CausticumDD5FO1WKFUACTIB
Cinchona Officinalis BarkS003A158SBACTIB
Conium Maculatum Flowering TopQ28R5GF371ACTIB
Solanum Dulcamara StemIR986LE7DFACTIB
Ferrosoferric Phosphate91GQH8I5F7ACTIB
Calcium Sulfide1MBW07J51QACTIB
Potassium Sulfate1K573LC5TVACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
MercuryFXS1BY2PGLACTIB
Daphne Mezereum BarkX2N6E405GVACTIB
Phosphorus27YLU75U4WACTIB
Plantago MajorW2469WNO6UACTIB
Pulsatilla VulgarisI76KB35JEVACTIB
Silicon DioxideETJ7Z6XBU4ACTIB
Verbascum ThapsusC9TD27U172ACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
GoldensealZW3Z11D0JVACTIB
Influenza B Virus1314JZ2X6WACTIB
Alcohol3K9958V90MIACT

Source Document#

Source XML

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.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates

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
a54763fa-079d-2c5e-9b0b-ebc30284d3c8e7c5d1e7-8f0b-bb84-9e95-d41af27bdf522011-06-01WarningsExact identifier
spl id: a54763fa-079d-2c5e-9b0b-ebc30284d3c8
spl set id: e7c5d1e7-8f0b-bb84-9e95-d41af27bdf52

Reported adverse events (FAERS/openFDA)#

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