Teeth-Gums
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2025-02-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:31:55
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Formulated for associated symptoms such as mouth sores, bad breath, toothache, inflammation and gum sensitivity.
OTC - ACTIVE INGREDIENT SECTION
Equal parts of Chamomilla 6x, Echinacea 6x, Aconitum napellus 15x, Arnica montana 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Belladonna 15x, Bryonia 15x, Calendula officinalis 15x, Chamomilla 15x, Chelidonium majus 15x, Crotalus horridus 15x, Gelsemium sempervirens 15x, Hepar sulphuris calcareum 15x, Kreosotum 15x, Mercurius vivus 15x, Myrrha 15x, Nux vomica 15x, Phosphorus 15x, Phytolacca decandra 15x, Plantago major 15x, Rhus toxicodendron 15x, Silicea 15x, Staphysagria 15x.
OTC - PURPOSE SECTION
Formulated for associated symptoms such as mouth sores, bad breath, toothache, inflammation and gum sensitivity.
INACTIVE INGREDIENT SECTION
Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.
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.
DOSAGE & ADMINISTRATION SECTION
Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive person begin with 1 pellet and gradually increase to full dose.
PACKAGE LABEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 63f39a63-5cd1-4016-bd86-2bbb0f6c3139 | Product name | 3 | 20240506 |
| e5a77e9c-c528-733a-173d-914a234c024b | Product name | 5 | 20240506 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-2529-1 | Teeth-Gums | 28 g in 1 BOTTLE, GLASS | PELLET | 28 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-2529 | TEETH-GUMS (CHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIA) PELLET [NEWTON LABORATORIES, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250212_9d363a40-a17b-2b6f-e053-2a95a90a3384.zip |
Products#
Every source-derived product name is available through these pages.
- Teeth-Gums
- Chamomilla, Echinacea, Aconitum napellus, Arnica montana, Arsenicum album, Baptisia tinctoria, Belladonna, Bryonia, Calendula officinalis, Chamomilla, Chelidonium majus, Crotalus horridus, Gelsemium sempervirens, Hepar sulphuris calcareum, Kreosotum, Mercurius vivus, Myrrha, Nux vomica, Phosphorus, Phytolacca decandra, Plantago major, Rhus toxicodendron, Silicea, Staphysagria
- ECHINACEA, UNSPECIFIED
- ALCOHOL
- ARSENIC TRIOXIDE
- ARSENIC CATION (3+)
- BAPTISIA TINCTORIA ROOT
- ATROPA BELLADONNA
- BRYONIA ALBA ROOT
- CALENDULA OFFICINALIS FLOWERING TOP
- MATRICARIA CHAMOMILLA
- CHELIDONIUM MAJUS
- CROTALUS HORRIDUS HORRIDUS VENOM
- ACONITUM NAPELLUS
- CALCIUM SULFIDE
- WOOD CREOSOTE
- MERCURY
- MYRRH
- STRYCHNOS NUX-VOMICA SEED
- PHOSPHORUS
- PHYTOLACCA AMERICANA ROOT
- PLANTAGO MAJOR
- TOXICODENDRON PUBESCENS LEAF
- SILICON DIOXIDE
- ARNICA MONTANA
- GELSEMIUM SEMPERVIRENS ROOT
- DELPHINIUM STAPHISAGRIA SEED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-2529 | 55714-2529-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| Teeth-Gums | CHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIA | Newton Laboratories, Inc. | 9d363a40-a17b-2b6f-e053-2a95a90a3384 | 2025-02-10 | Warnings | 55714-2529-1 55714-2529 55714252901 2dd1c759-635e-a5e6-e063-6294a90ae727 9d363a40-a17b-2b6f-e053-2a95a90a3384 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
