Homeopathic Cold and Canker Sore Formula
- Manufacturer
- Indiana Botanic Gardens | ASI Marketing Group
- Effective date
- 2011-03-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:03:13
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
I n g r e d i e n t s :
Antimony trisulfide........................ 10X HPUS
Honeybee................................. 10X HPUS
Copper.......................... 10X HPUS
Gopher plant...........................10X HPUS
Poison oak........................ 12X 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 relief of cold and canker sores
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF
REACH OF CHILDREN.
INDICATIONS & USAGE SECTION
For relief of cold and canker sores
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 up to 4 times daily until symptoms subside,
or as directed by a health professional. If
symptoms persist for more than 7 days or worsen consult a
health professional.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Dextrose, Magnesium
Stearate, Silica.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c599c4a0-705d-4ebb-ab1f-977af038f96a | Product name | 1 | 20251124 |
| ed912195-5da0-0f2f-6f4b-3ef17710cbe3 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10578-052-90 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d0e2-8e05-e053-dbdaa90a074a | Homeopathic Cold and Canker Sore Formula |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10578-052-90 | Homeopathic Cold and Canker Sore Formula | 90 in 1 BOTTLE | TABLET | 90 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 10578-052 | HOMEOPATHIC COLD AND CANKER SORE FORMULA (ANTIMONUM CRUDUM, APIS MELLIFICA, CUPRUM METALLICUM, EUPHORBIA LATHYRIS, RHUS TOXICODENDRON) TABLET [INDIANA BOTANIC GARDENS] | 2 | Legacy NDC, 1 package rows | 20110627_ed169621-d986-4d6c-bb67-a91eb5880788.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ANTIMONY TRISULFIDE | ACTIVE INGREDIENT | F79059A38U | 2 | |
| APIS MELLIFERA | ACTIVE INGREDIENT | 7S82P3R43Z | 2 | |
| COPPER | ACTIVE INGREDIENT | 789U1901C5 | 2 | |
| EUPHORBIA LATHYRIS | ACTIVE INGREDIENT | GHV7FV90K2 | 2 | |
| TOXICODENDRON PUBESCENS LEAF | ACTIVE INGREDIENT | 6IO182RP7A | 2 | |
| ANTIMONY CATION (3+) | ACTIVE MOIETY | 069647RPT5 | 2 | |
| APIS MELLIFERA | ACTIVE MOIETY | 7S82P3R43Z | 2 | |
| COPPER | ACTIVE MOIETY | 789U1901C5 | 2 | |
| EUPHORBIA LATHYRIS | ACTIVE MOIETY | GHV7FV90K2 | 2 | |
| TOXICODENDRON PUBESCENS LEAF | ACTIVE MOIETY | 6IO182RP7A | 2 | |
| DEXTROSE | INACTIVE INGREDIENT | IY9XDZ35W2 | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 |
Products#
Every source-derived product name is available through these pages.
- Homeopathic Cold and Canker Sore Formula
- Antimonum crudum, Apis mellifica, Cuprum metallicum, Euphorbia lathyris, Rhus toxicodendron
- ANTIMONY TRISULFIDE
- ANTIMONY CATION (3+)
- APIS MELLIFERA
- COPPER
- EUPHORBIA LATHYRIS
- TOXICODENDRON PUBESCENS LEAF
- DEXTROSE
- MAGNESIUM STEARATE
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10578-052 | 10578-052-90 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANTIMONY TRISULFIDE | F79059A38U | ACTIB |
| APIS MELLIFERA | 7S82P3R43Z | ACTIB |
| COPPER | 789U1901C5 | ACTIB |
| EUPHORBIA LATHYRIS | GHV7FV90K2 | ACTIB |
| TOXICODENDRON PUBESCENS LEAF | 6IO182RP7A | ACTIB |
| DEXTROSE | IY9XDZ35W2 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / SUBLINGUAL | 10 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | CONCENTRATE / ORAL | 400 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | SOLUTION / ORAL | 2489 mg/5ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | SYRUP / ORAL | 620 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | POWDER, FOR SOLUTION / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / BUCCAL | 17.5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | POWDER / VAGINAL | 430 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / SUBCUTANEOUS | 0.5 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | INJECTION / INTRAVENOUS | 5 %w/v | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / DENTAL | 19 %w/w | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | INJECTION / INTRAMUSCULAR | 5 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | SPRAY, METERED / NASAL | 50 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / RESPIRATORY (INHALATION) | 0.13 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / INTRAVITREAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, DELAYED RELEASE / ORAL | 144 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | TABLET, EXTENDED RELEASE / ORAL | 103.95 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / TRANSMUCOSAL | 100 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | TROCHE / ORAL | 903.5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| DEXTROSE | DEXTROSE | IY9XDZ35W2 | INJECTION / INTRASPINAL | 75 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | DROPS / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 58f045c3-7a2c-2927-e063-6394a90a97e4 | ed169621-d986-4d6c-bb67-a91eb5880788 | 2026-08-13 | Warnings | ed169621-d986-4d6c-bb67-a91eb5880788 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
