FDA.reportPublic FDA data

Ear Care

Manufacturer
Newton Laboratories, Inc.
Effective date
2022-03-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:17:11

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 TOP, FERROSOFERRIC PHOSPHATE, CALCIUM SULFIDE, POTASSIUM SULFATE, LYCOPODIUM CLAVATUM SPORE, MERCURY, DAPHNE MEZEREUM BARK, PHOSPHORUS, PLANTAGO MAJOR, ANEMONE PULSATILLA, SILICON DIOXIDE, VERBASCUM THAPSUS, ECHINACEA, UNSPECIFIED, GOLDENSEAL, INFLUENZA B VIRUS
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as pain, fever, inflammation, redness, congestion, itching and pressure.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parats of Echinacea 6x, Hydrastis 6x, Apis mel. 15x, Arsenicum alb. 15x, Belladonna 15x, Bryonia 15x, Capsicum 15x, Causticum 15x, Cinchona 15x, Conium 15x, Dulcamara 15x, Ferrum phos. 15x, Hepar sulph. calc. 15x, Kali sulph. 15x, Lycopodium 15x, Merc. viv. 15x, Mezereum 15x, Phos. 15x, Plantago 15x, Pulsatilla 15x, Silicea 15x, Verbascum 15x, Tellurium 16x, Influenzinum 30x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as pain, fever, inflammation, redness, congestion, itching and pressure.

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

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4846-1Ear Care30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4846EAR 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.]1Current NDC, Legacy NDC, 1 package rows20220319_da821d05-b2f0-3582-e053-2a95a90afe59.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-484655714-4846-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
INFLUENZA A VIRUSR9HH0NDE2EACTIB
TELLURIUMNQA0O090ZJACTIB
APIS MELLIFERA7S82P3R43ZACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CAPSICUM00UK7646FGACTIB
CAUSTICUMDD5FO1WKFUACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
SOLANUM DULCAMARA TOPKPS1B1162NACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
POTASSIUM SULFATE1K573LC5TVACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
MERCURYFXS1BY2PGLACTIB
DAPHNE MEZEREUM BARKX2N6E405GVACTIB
PHOSPHORUS27YLU75U4WACTIB
PLANTAGO MAJORW2469WNO6UACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
VERBASCUM THAPSUSC9TD27U172ACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
GOLDENSEALZW3Z11D0JVACTIB
INFLUENZA B VIRUS1314JZ2X6WACTIB
WATER059QF0KO0RIACT

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
Ear CareINFLUENZINUM, 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, HYDRASTISNewton Laboratories, Inc.da821d05-b2f0-3582-e053-2a95a90afe592022-03-18WarningsExact identifier
ndc (package): 55714-4846-1
ndc (product): 55714-4846
ndc11 (package): 55714484601
spl id: da821e18-7dab-2f4e-e053-2995a90ac2d6
spl set id: da821d05-b2f0-3582-e053-2a95a90afe59

Reported adverse events (FAERS/openFDA)#

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