Homeopathic Ear Ache Formula

Manufacturer: Indiana Botanic Gardens | ASI Marketing Group
Effective date: 2011-03-25
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 01:51:12

Label at a glance#

ProductHomeopathic Ear Ache Formula

Active ingredientACONITUM NAPELLUS, ATROPA BELLADONNA, CAPSICUM, CHAMOMILE, FERRUM PHOSPHORICUM, POTASSIUM CHLORIDE

Label structure10 sections

Contacts and useful links#

PhoneLabel contact1-800-644-8327

Websitewww.botanicchoice.com

www.botanicchoice.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

I n g r e d i e n t s :

Aconite.............................. 30C HPUS
Deadly nightshade..........................................30C HPUS
Cayenne pepper......................... .................30C HPUS
Chamomile.........................................30C HPUS

Phosphate of iron..........................30C HPUS

Potassium chloride...................................30C HPUS

The letters “HPUS” indicate that the components in
this product are officially monographed in the
Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

For the relief of ear pain due to soreness and swelling

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF
REACH OF CHILDREN.

INDICATIONS & USAGE SECTION

For the relief of ear pain due to soreness and swelling

WARNINGS SECTION

Warning: If you are taking any medications or
are pregnant or breast feeding do not use prior to
consulting a physician.

DOSAGE & ADMINISTRATION SECTION

Suggested Use: Adults and children over 12
years, take 2 tablets, dissolve under tongue or
chew 3 times daily or as directed by a health care professional. If
condition worsens after 2 days and is accompanied by a high fever consult your
health professional.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Dextrose, Magnesium
Stearate, Silica.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC# 1057804890

Homeopathic Ear Ache Formula

For the relief of ear pain due to soreness and swelling

300 mg.
90 Tablets

USER SAFETY WARNINGS SECTION

For your protection, this container has an outer
safety seal. (Do not accept if missing or broken.)
Best if used by date on bottle. Store in a dry cool place.
Any Questions? 1-800-644-8327
website: www.botanicchoice.com

SPL UNCLASSIFIED SECTION

FDA Establishment #: 1811575

Distributed by: Indiana Botanic Gardens, Inc.
3401 W. 37th Ave. Hobart, IN 46342

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10578-048-90	2021-01-22	C162847	48780-1	960f7f55-cabe-8e05-e053-dbdaa90a074a	Homeopathic Ear Ache Formula
10578-048-90	2019-10-29	C162847	48780-1	960f7f55-cabe-8e05-e053-dbdaa90a074a	Homeopathic Ear Ache Formula

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACONITUM NAPELLUS	ACTIVE INGREDIENT	U0NQ8555JD	3
ATROPA BELLADONNA	ACTIVE INGREDIENT	WQZ3G9PF0H	3
CAPSICUM	ACTIVE INGREDIENT	00UK7646FG	3
CHAMOMILE	ACTIVE INGREDIENT	FGL3685T2X	3
FERRUM PHOSPHORICUM	ACTIVE INGREDIENT	91GQH8I5F7	3
POTASSIUM CHLORIDE	ACTIVE INGREDIENT	660YQ98I10	3
ACONITUM NAPELLUS	ACTIVE MOIETY	U0NQ8555JD	3
ATROPA BELLADONNA	ACTIVE MOIETY	WQZ3G9PF0H	3
CAPSICUM	ACTIVE MOIETY	00UK7646FG	3
CHAMOMILE	ACTIVE MOIETY	FGL3685T2X	3
FERRUM PHOSPHORICUM	ACTIVE MOIETY	91GQH8I5F7	3
POTASSIUM CATION	ACTIVE MOIETY	295O53K152	3
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	3

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Homeopathic Ear Ache Formula
Aconitum napellus, Belladonna, Capsicum, Chamomile, Ferrum phosphoricum, Kali muriaticum
ACONITUM NAPELLUS
ATROPA BELLADONNA
CAPSICUM
CHAMOMILE
FERRUM PHOSPHORICUM
POTASSIUM CHLORIDE
POTASSIUM CATION
DEXTROSE
MAGNESIUM STEARATE
SILICON DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10578-048	10578-048-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACONITUM NAPELLUS	U0NQ8555JD	ACTIB
ATROPA BELLADONNA	WQZ3G9PF0H	ACTIB
CAPSICUM	00UK7646FG	ACTIB
CHAMOMILE	FGL3685T2X	ACTIB
FERRUM PHOSPHORICUM	91GQH8I5F7	ACTIB
POTASSIUM CHLORIDE	660YQ98I10	ACTIB
DEXTROSE	IY9XDZ35W2	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	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 2 · 109 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	SOLUTION / ORAL	2489 mg/5ml		Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	DROPS / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / SUBCUTANEOUS	0.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	CONCENTRATE / ORAL	400 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	PASTILLE / ORAL	826 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TROCHE / ORAL		315 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	INJECTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TROCHE / ORAL	903.5 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	INJECTION / INTRAMUSCULAR	5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	INJECTION, SOLUTION / INTRATHECAL		1925 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET, EXTENDED RELEASE / ORAL	103.95 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET, CHEWABLE / ORAL		1286 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	POWDER / VAGINAL	430 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	WAFER / ORAL	66 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	SOLUTION / INTRAVENOUS	5.05 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	RING / VAGINAL		2 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET / ORAL	183.66 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET / SUBLINGUAL	115.78 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, EXTENDED RELEASE / ORAL		117 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 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
80c2d292-0487-4a23-bf60-31ef31aed78f			9fbaa2c3-0a23-4500-9948-10bdbe9f4bde	2021-01-22	Warnings	Exact identifier spl set id: 9fbaa2c3-0a23-4500-9948-10bdbe9f4bde

Reported adverse events (FAERS/openFDA)#

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