FDA.reportPublic FDA data

Teeth - Gums

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:04:47

Label at a glance#

ProductTeeth - Gums
Active ingredientAconitum Napellus, Arnica Montana, Arsenic Trioxide, Baptisia Tinctoria, Atropa Belladonna, Bryonia Alba Root, Calendula Officinalis Flowering Top, Matricaria Recutita, Chelidonium Majus, Crotalus Horridus Horridus Venom, Gelsemium Sempervirens Root, Calcium Sulfide, Wood Creosote, Mercury, Myrrh, Strychnos Nux-vomica Seed, Phosphorus, Phytolacca Americana Root, Plantago Major, Toxicodendron Pubescens Leaf, Silicon Dioxide, Delphinium Staphisagria Seed, Echinacea, Unspecified
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Teeth - Gums  Formulated for associated symptoms including mouth sores, bad breath, toothache, inflammation and gum sensitivity.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Aconitum nap. 15x, Arnica 15x, Arsenicum alb. 15x, Baptisia 15x, Belladonna 15x, Bryonia 15x, Calendula 15x, Chamomilla 15x, Chelidonium majus 15x, Crotalus horridus 15x, Gelsemium 15x, Hepar sulph. calc. 15x, Kreosotum15x, Merc. viv. 15x, Myrrha 15x, Nux vom. 15x, Phosphorus 15x, Phytolacca 15x, Plantago 15x, Rhus toxicodendron 15x, Silicea 15x, Staphysag. 15x, Chamomilla 3x, Echinacea 3x.

OTC - PURPOSE SECTION

 Formulated for associated symptoms including mouth sores, bad breath, toothache, inflammation and gum sensitivity.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

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

package label
package label

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2282-02020-01-31C16284748780-19d75b9d0-9778-f424-e053-dadaa90a57ceTeeth - Gums
55714-2282-12020-01-31C16284748780-19d75b9d0-9778-f424-e053-dadaa90a57ceTeeth - Gums
55714-2282-22020-01-31C16284748780-19d75b9d0-9778-f424-e053-dadaa90a57ceTeeth - Gums

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2282-0Teeth - Gums.5 mL in 1 BOTTLE, GLASSLIQUID.52
55714-2282-1Teeth - Gums29.57 mL in 1 BOTTLE, GLASSLIQUID29.572
55714-2282-2Teeth - Gums29.14 mL in 1 BOTTLE, GLASSLIQUID29.142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2282TEETH - GUMS (ACONITUM NAP., ARNICA, ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CALENDULA, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM, HEPAR SULPH. CALC., KREOSOTUM, MERC. VIV., MYRRHA, NUX VOM., PHOSPHORUS, PHYTOLACCA, PLANTAGO, RHUS TOXICODENDRON, SILICEA, STAPHYSAG., ECHINACEA) LIQUID [NEWTON LABORATORIES, INC.]2Legacy NDC, 3 package rows20130802_171b2305-155b-e490-d4f9-d2334b36b4ff.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aconitum NapellusACTIVE INGREDIENTU0NQ8555JD2
Arnica MontanaACTIVE INGREDIENTO80TY208ZW2
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO2
Atropa BelladonnaACTIVE INGREDIENTWQZ3G9PF0H2
Baptisia TinctoriaACTIVE INGREDIENT5K1UO2888Y2
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B2
Calcium SulfideACTIVE INGREDIENT1MBW07J51Q2
Calendula Officinalis Flowering TopACTIVE INGREDIENT18E7415PXQ2
Chelidonium MajusACTIVE INGREDIENT7E889U5RNN2
Crotalus Horridus Horridus VenomACTIVE INGREDIENTYHA2XLJ9562
Delphinium Staphisagria SeedACTIVE INGREDIENT00543AP1JV2
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX2
Gelsemium Sempervirens RootACTIVE INGREDIENT639KR60Q1Q2
Matricaria RecutitaACTIVE INGREDIENTG0R4UBI2ZZ2
MercuryACTIVE INGREDIENTFXS1BY2PGL2
MyrrhACTIVE INGREDIENTJC71GJ1F3L2
PhosphorusACTIVE INGREDIENT27YLU75U4W2
Phytolacca Americana RootACTIVE INGREDIENT11E6VI8VEG2
Plantago MajorACTIVE INGREDIENTW2469WNO6U2
Silicon DioxideACTIVE INGREDIENTETJ7Z6XBU42
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139192
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A2
Wood CreosoteACTIVE INGREDIENT3JYG22FD732
Aconitum NapellusACTIVE MOIETYU0NQ8555JD2
Arnica MontanaACTIVE MOIETYO80TY208ZW2
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV2
Atropa BelladonnaACTIVE MOIETYWQZ3G9PF0H2
Baptisia TinctoriaACTIVE MOIETY5K1UO2888Y2
Bryonia Alba RootACTIVE MOIETYT7J046YI2B2
Calcium SulfideACTIVE MOIETY1MBW07J51Q2
Calendula Officinalis Flowering TopACTIVE MOIETY18E7415PXQ2
Chelidonium MajusACTIVE MOIETY7E889U5RNN2
Crotalus Horridus Horridus VenomACTIVE MOIETYYHA2XLJ9562
Delphinium Staphisagria SeedACTIVE MOIETY00543AP1JV2
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX2
Gelsemium Sempervirens RootACTIVE MOIETY639KR60Q1Q2
Matricaria RecutitaACTIVE MOIETYG0R4UBI2ZZ2
MercuryACTIVE MOIETYFXS1BY2PGL2
MyrrhACTIVE MOIETYJC71GJ1F3L2
PhosphorusACTIVE MOIETY27YLU75U4W2
Phytolacca Americana RootACTIVE MOIETY11E6VI8VEG2
Plantago MajorACTIVE MOIETYW2469WNO6U2
Silicon DioxideACTIVE MOIETYETJ7Z6XBU42
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139192
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A2
Wood CreosoteACTIVE MOIETY3JYG22FD732
AlcoholINACTIVE INGREDIENT3K9958V90M2

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
55714-228255714-2282-1, 55714-2282-2, 55714-2282-0

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
Aconitum NapellusU0NQ8555JDACTIB
Arnica MontanaO80TY208ZWACTIB
Arsenic TrioxideS7V92P67HOACTIB
Baptisia Tinctoria5K1UO2888YACTIB
Atropa BelladonnaWQZ3G9PF0HACTIB
Bryonia Alba RootT7J046YI2BACTIB
Calendula Officinalis Flowering Top18E7415PXQACTIB
Matricaria RecutitaG0R4UBI2ZZACTIB
Chelidonium Majus7E889U5RNNACTIB
Crotalus Horridus Horridus VenomYHA2XLJ956ACTIB
Gelsemium Sempervirens Root639KR60Q1QACTIB
Calcium Sulfide1MBW07J51QACTIB
Wood Creosote3JYG22FD73ACTIB
MercuryFXS1BY2PGLACTIB
MyrrhJC71GJ1F3LACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Phosphorus27YLU75U4WACTIB
Phytolacca Americana Root11E6VI8VEGACTIB
Plantago MajorW2469WNO6UACTIB
Toxicodendron Pubescens Leaf6IO182RP7AACTIB
Silicon DioxideETJ7Z6XBU4ACTIB
Delphinium Staphisagria Seed00543AP1JVACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
Alcohol3K9958V90MIACT

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 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
26bb8fdc-df6f-d2f7-0482-c007c3558335171b2305-155b-e490-d4f9-d2334b36b4ff2011-03-01WarningsExact identifier
spl id: 26bb8fdc-df6f-d2f7-0482-c007c3558335
spl set id: 171b2305-155b-e490-d4f9-d2334b36b4ff

Reported adverse events (FAERS/openFDA)#

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