Ear Care

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 02:05:04

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, Pulsatilla Vulgaris, Silicon Dioxide, Verbascum Thapsus, Echinacea, Unspecified, Goldenseal, Influenza B Virus

Label structure10 sections

Contacts and useful links#

PhoneLabel contact1.800.448.7256

Websitewww.newtonlabs.net

www.newtonlabs.net

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Ear Care Formulated for symptoms associated with ear conditions such as redness, pain, congestion, hearing difficulty, inflammation and irritability.

DOSAGE & ADMINISTRATION SECTION

Directions: Children, ages 0 to 11, give 3 pellets orally (ages 12 and up, give 6 pellets) one to four times daily or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

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.

OTC - PURPOSE SECTION

Formulated for symptoms associated with ear conditions such as redness, pain, congestion, hearing difficulty, inflammation and irritability.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

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.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
63f39a63-5cd1-4016-bd86-2bbb0f6c3139	Product name	3	20240506
e5a77e9c-c528-733a-173d-914a234c024b	Product name	5	20240506
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55714-1704-0	2020-01-31	C162847	48780-1	9d75b9cf-d49c-f424-e053-dadaa90a57ce	Ear Care
55714-1704-1	2020-01-31	C162847	48780-1	9d75b9cf-d49c-f424-e053-dadaa90a57ce	Ear Care
55714-1704-2	2020-01-31	C162847	48780-1	9d75b9cf-d49c-f424-e053-dadaa90a57ce	Ear Care

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55714-1704-0	Ear Care	7.08 g in 1 BOTTLE, GLASS	PELLET	7.08	1
55714-1704-1	Ear Care	28.35 g in 1 BOTTLE, GLASS	PELLET	28.35	1
55714-1704-2	Ear Care	56.7 g in 1 BOTTLE, GLASS	PELLET	56.7	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55714-1704	EAR CARE (INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, AUSTICUM, CINCHONA, CONIUM,DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., YCOPODIUM, MERC. VIV., MEZEREUM,PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA,VERBASCUM, ECHINACEA, HYDRASTIS) PELLET [NEWTON LABORATORIES, INC.]	1	Legacy NDC, 3 package rows	20131022_636bb6b9-0a9f-7c14-cc14-ca81c219b294.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Apis Mellifera	ACTIVE INGREDIENT	7S82P3R43Z	1
Arsenic Trioxide	ACTIVE INGREDIENT	S7V92P67HO	1
Atropa Belladonna	ACTIVE INGREDIENT	WQZ3G9PF0H	1
Bryonia Alba Root	ACTIVE INGREDIENT	T7J046YI2B	1
Calcium Sulfide	ACTIVE INGREDIENT	1MBW07J51Q	1
Capsicum	ACTIVE INGREDIENT	00UK7646FG	1
Causticum	ACTIVE INGREDIENT	DD5FO1WKFU	1
Cinchona Officinalis Bark	ACTIVE INGREDIENT	S003A158SB	1
Conium Maculatum Flowering Top	ACTIVE INGREDIENT	Q28R5GF371	1
Daphne Mezereum Bark	ACTIVE INGREDIENT	X2N6E405GV	1
Echinacea, Unspecified	ACTIVE INGREDIENT	4N9P6CC1DX	1
Ferrosoferric Phosphate	ACTIVE INGREDIENT	91GQH8I5F7	1
Goldenseal	ACTIVE INGREDIENT	ZW3Z11D0JV	1
Influenza A Virus	ACTIVE INGREDIENT	R9HH0NDE2E	1
Influenza B Virus	ACTIVE INGREDIENT	1314JZ2X6W	1
Lycopodium Clavatum Spore	ACTIVE INGREDIENT	C88X29Y479	1
Mercury	ACTIVE INGREDIENT	FXS1BY2PGL	1
Phosphorus	ACTIVE INGREDIENT	27YLU75U4W	1
Plantago Major	ACTIVE INGREDIENT	W2469WNO6U	1
Potassium Sulfate	ACTIVE INGREDIENT	1K573LC5TV	1
Pulsatilla Vulgaris	ACTIVE INGREDIENT	I76KB35JEV	1
Silicon Dioxide	ACTIVE INGREDIENT	ETJ7Z6XBU4	1
Solanum Dulcamara Top	ACTIVE INGREDIENT	KPS1B1162N	1
Tellurium	ACTIVE INGREDIENT	NQA0O090ZJ	1
Verbascum Thapsus	ACTIVE INGREDIENT	C9TD27U172	1
Apis Mellifera	ACTIVE MOIETY	7S82P3R43Z	1
Arsenic Cation (3+)	ACTIVE MOIETY	C96613F5AV	1
Atropa Belladonna	ACTIVE MOIETY	WQZ3G9PF0H	1
Bryonia Alba Root	ACTIVE MOIETY	T7J046YI2B	1
Calcium Sulfide	ACTIVE MOIETY	1MBW07J51Q	1
Capsicum	ACTIVE MOIETY	00UK7646FG	1
Causticum	ACTIVE MOIETY	DD5FO1WKFU	1
Cinchona Officinalis Bark	ACTIVE MOIETY	S003A158SB	1
Conium Maculatum Flowering Top	ACTIVE MOIETY	Q28R5GF371	1
Daphne Mezereum Bark	ACTIVE MOIETY	X2N6E405GV	1
Echinacea, Unspecified	ACTIVE MOIETY	4N9P6CC1DX	1
Ferrosoferric Phosphate	ACTIVE MOIETY	91GQH8I5F7	1
Goldenseal	ACTIVE MOIETY	ZW3Z11D0JV	1
Influenza A Virus	ACTIVE MOIETY	R9HH0NDE2E	1
Influenza B Virus	ACTIVE MOIETY	1314JZ2X6W	1
Lycopodium Clavatum Spore	ACTIVE MOIETY	C88X29Y479	1
Mercury	ACTIVE MOIETY	FXS1BY2PGL	1
Phosphorus	ACTIVE MOIETY	27YLU75U4W	1
Plantago Major	ACTIVE MOIETY	W2469WNO6U	1
Pulsatilla Vulgaris	ACTIVE MOIETY	I76KB35JEV	1
Silicon Dioxide	ACTIVE MOIETY	ETJ7Z6XBU4	1
Solanum Dulcamara Top	ACTIVE MOIETY	KPS1B1162N	1
Sulfate Ion	ACTIVE MOIETY	7IS9N8KPMG	1
Tellurium	ACTIVE MOIETY	NQA0O090ZJ	1
Verbascum Thapsus	ACTIVE MOIETY	C9TD27U172	1
Sucrose	INACTIVE INGREDIENT	C151H8M554	1

Products#

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

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

Ear Care
Influenzinum, Tellurium metallicum, Apis mel., Arsenicum alb., Belladonna, Bryonia, Capsicum, austicum, Cinchona, Conium,Dulcamara, Ferrum phosphoricum, Hepar sulph. calc.,Kali sulph., ycopodium, Merc. viv., Mezereum,Phosphorus, Plantago, Pulsatilla, Silicea,Verbascum, Echinacea, Hydrastis
Influenza A Virus
Tellurium
Apis Mellifera
Arsenic Trioxide
Arsenic Cation (3+)
Atropa Belladonna
Bryonia Alba Root
Capsicum
Causticum
Cinchona Officinalis Bark
Conium Maculatum Flowering Top
Solanum Dulcamara Top
Ferrosoferric Phosphate
Calcium Sulfide
Potassium Sulfate
Sulfate Ion
Lycopodium Clavatum Spore
Mercury
Daphne Mezereum Bark
Phosphorus
Plantago Major
Pulsatilla Vulgaris
Silicon Dioxide
Verbascum Thapsus
Echinacea, Unspecified
Goldenseal
Influenza B Virus
Sucrose

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-1704	55714-1704-1, 55714-1704-2, 55714-1704-0

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
Name	UNII	Kind
Influenza A Virus	R9HH0NDE2E	ACTIB
Tellurium	NQA0O090ZJ	ACTIB
Apis Mellifera	7S82P3R43Z	ACTIB
Arsenic Trioxide	S7V92P67HO	ACTIB
Atropa Belladonna	WQZ3G9PF0H	ACTIB
Bryonia Alba Root	T7J046YI2B	ACTIB
Capsicum	00UK7646FG	ACTIB
Causticum	DD5FO1WKFU	ACTIB
Cinchona Officinalis Bark	S003A158SB	ACTIB
Conium Maculatum Flowering Top	Q28R5GF371	ACTIB
Solanum Dulcamara Top	KPS1B1162N	ACTIB
Ferrosoferric Phosphate	91GQH8I5F7	ACTIB
Calcium Sulfide	1MBW07J51Q	ACTIB
Potassium Sulfate	1K573LC5TV	ACTIB
Lycopodium Clavatum Spore	C88X29Y479	ACTIB
Mercury	FXS1BY2PGL	ACTIB
Daphne Mezereum Bark	X2N6E405GV	ACTIB
Phosphorus	27YLU75U4W	ACTIB
Plantago Major	W2469WNO6U	ACTIB
Pulsatilla Vulgaris	I76KB35JEV	ACTIB
Silicon Dioxide	ETJ7Z6XBU4	ACTIB
Verbascum Thapsus	C9TD27U172	ACTIB
Echinacea, Unspecified	4N9P6CC1DX	ACTIB
Goldenseal	ZW3Z11D0JV	ACTIB
Influenza B Virus	1314JZ2X6W	ACTIB
Sucrose	C151H8M554	IACT

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 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sucrose	SUCROSE	C151H8M554	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, EMULSION / INTRAVENOUS		970 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SUSPENSION / ORAL		40017 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / SUBLINGUAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION/ DROPS / ORAL		3750 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / SUBCUTANEOUS	47.75 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / BUCCAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / RECTAL	35.42 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	DROPS / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / TRANSMUCOSAL		1255 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED PELLETS / ORAL	59.8 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION / ORAL		31885 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / INTRAVENOUS		1950 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 mg	Exact identifier — unii candidate 48 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
7250cac6-2d4e-0785-c5ff-3ce7cc21a4e0			636bb6b9-0a9f-7c14-cc14-ca81c219b294	2011-03-01	Warnings	Exact identifier spl id: 7250cac6-2d4e-0785-c5ff-3ce7cc21a4e0 spl set id: 636bb6b9-0a9f-7c14-cc14-ca81c219b294

Reported adverse events (FAERS/openFDA)#

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