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#

ProductTeeth-Gums
Active ingredientECHINACEA, UNSPECIFIED, ARSENIC TRIOXIDE, 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
Label structure10 sections

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

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.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2529-1Teeth-Gums28 g in 1 BOTTLE, GLASSPELLET283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2529TEETH-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.]3Current NDC, Legacy NDC, 1 package rows20250212_9d363a40-a17b-2b6f-e053-2a95a90a3384.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-252955714-2529-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

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
Teeth-GumsCHAMOMILLA, 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, STAPHYSAGRIANewton Laboratories, Inc.9d363a40-a17b-2b6f-e053-2a95a90a33842025-02-10WarningsExact identifier
ndc (package): 55714-2529-1
ndc (product): 55714-2529
ndc11 (package): 55714252901
spl id: 2dd1c759-635e-a5e6-e063-6294a90ae727
spl set id: 9d363a40-a17b-2b6f-e053-2a95a90a3384

Reported adverse events (FAERS/openFDA)#

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