Oral Care - Gingivitis

Manufacturer: Newton Laboratories, Inc.
Effective date: 2011-06-01
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:05:07

Label at a glance#

ProductOral Care - Gingivitis

Active ingredientAconitum Napellus, Arnica Montana, Arsenic Trioxide, Baptisia Tinctoria Root, 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, Plantago Major, Toxicodendron Pubescens Leaf, Silicon Dioxide, Delphinium Staphisagria Seed, Echinacea, Unspecified

Label structure10 sections

Contacts and useful links#

PhoneLabel contact1.800.448.7256

Websitewww.newtonlabs.net

www.newtonlabs.net

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Oral Care - Gingivitis Formulated for symptoms associated with periodontal conditions such as mouth ulcerations, gingivitis, halitosis, teeth pain and gum sensitivity.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Aconitum nap. 20x, Arnica 20x, Arsenicum alb. 20x, Baptisia 20x, Belladonna 20x, Bryonia 20x, Calendula 20x, Chamomilla 20x, Chelidonium majus 20x, Crotalus horridus 20x, Gelsemium 20x, Hepar sulph. calc. 20x, Kreosotum 20x, Merc. viv. 20x, Myrrha 20x, Nux vom. 20x, Phosphorus 20x, Phytolacca 20x, Plantago 20x, Rhus toxicodendron 20x, Silicea 20x, Staphysag. 20x, Chamomilla 8x, Echinacea 8x, Chamomilla 3x, Echinacea 3x.

PURPOSE SECTION

ABUSE SECTION

Formulated for symptoms associated with periodontal conditions such as mouth ulcerations, gingivitis, halitosis, teeth pain and gum sensitivity.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

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.

PREGNANCY OR BREAST FEEDING SECTION

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

KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PACKAGE LABEL.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139	Product name	3	20240506
e5a77e9c-c528-733a-173d-914a234c024b	Product name	5	20240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55714-4441-1	2020-01-31	C162847	48780-1	9d75b9d0-001c-f424-e053-dadaa90a57ce	Oral Care - Gingivitis
55714-4441-2	2020-01-31	C162847	48780-1	9d75b9d0-001c-f424-e053-dadaa90a57ce	Oral Care - Gingivitis

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55714-4441-1	Oral Care - Gingivitis	28.35 g in 1 BOTTLE, GLASS	PELLET	28.35		1
55714-4441-2	Oral Care - Gingivitis	56.7 g in 1 BOTTLE, GLASS	PELLET	56.7		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55714-4441	ORAL CARE - GINGIVITIS (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, SLICEA, STAPHYSAG., ECHINACEA) PELLET [NEWTON LABORATORIES, INC.]	1	Legacy NDC, 2 package rows	20131030_c6f22638-e6da-81fb-bfa6-d1668183fec0.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Aconitum Napellus	ACTIVE INGREDIENT	U0NQ8555JD	1
Arnica Montana	ACTIVE INGREDIENT	O80TY208ZW	1
Arsenic Trioxide	ACTIVE INGREDIENT	S7V92P67HO	1
Atropa Belladonna	ACTIVE INGREDIENT	WQZ3G9PF0H	1
Baptisia Tinctoria Root	ACTIVE INGREDIENT	5EF0HWI5WU	1
Bryonia Alba Root	ACTIVE INGREDIENT	T7J046YI2B	1
Calcium Sulfide	ACTIVE INGREDIENT	1MBW07J51Q	1
Calendula Officinalis Flowering Top	ACTIVE INGREDIENT	18E7415PXQ	1
Chelidonium Majus	ACTIVE INGREDIENT	7E889U5RNN	1
Crotalus Horridus Horridus Venom	ACTIVE INGREDIENT	YHA2XLJ956	1
Delphinium Staphisagria Seed	ACTIVE INGREDIENT	00543AP1JV	1
Echinacea, Unspecified	ACTIVE INGREDIENT	4N9P6CC1DX	1
Gelsemium Sempervirens Root	ACTIVE INGREDIENT	639KR60Q1Q	1
Matricaria Recutita	ACTIVE INGREDIENT	G0R4UBI2ZZ	1
Mercury	ACTIVE INGREDIENT	FXS1BY2PGL	1
Myrrh	ACTIVE INGREDIENT	JC71GJ1F3L	1
Phosphorus	ACTIVE INGREDIENT	27YLU75U4W	1
Plantago Major	ACTIVE INGREDIENT	W2469WNO6U	1
Silicon Dioxide	ACTIVE INGREDIENT	ETJ7Z6XBU4	1
Strychnos Nux-vomica Seed	ACTIVE INGREDIENT	269XH13919	1
Toxicodendron Pubescens Leaf	ACTIVE INGREDIENT	6IO182RP7A	1
Wood Creosote	ACTIVE INGREDIENT	3JYG22FD73	1
Aconitum Napellus	ACTIVE MOIETY	U0NQ8555JD	1
Arnica Montana	ACTIVE MOIETY	O80TY208ZW	1
Arsenic Cation (3+)	ACTIVE MOIETY	C96613F5AV	1
Atropa Belladonna	ACTIVE MOIETY	WQZ3G9PF0H	1
Baptisia Tinctoria Root	ACTIVE MOIETY	5EF0HWI5WU	1
Bryonia Alba Root	ACTIVE MOIETY	T7J046YI2B	1
Calcium Sulfide	ACTIVE MOIETY	1MBW07J51Q	1
Calendula Officinalis Flowering Top	ACTIVE MOIETY	18E7415PXQ	1
Chelidonium Majus	ACTIVE MOIETY	7E889U5RNN	1
Crotalus Horridus Horridus Venom	ACTIVE MOIETY	YHA2XLJ956	1
Delphinium Staphisagria Seed	ACTIVE MOIETY	00543AP1JV	1
Echinacea, Unspecified	ACTIVE MOIETY	4N9P6CC1DX	1
Gelsemium Sempervirens Root	ACTIVE MOIETY	639KR60Q1Q	1
Matricaria Recutita	ACTIVE MOIETY	G0R4UBI2ZZ	1
Mercury	ACTIVE MOIETY	FXS1BY2PGL	1
Myrrh	ACTIVE MOIETY	JC71GJ1F3L	1
Phosphorus	ACTIVE MOIETY	27YLU75U4W	1
Plantago Major	ACTIVE MOIETY	W2469WNO6U	1
Silicon Dioxide	ACTIVE MOIETY	ETJ7Z6XBU4	1
Strychnos Nux-vomica Seed	ACTIVE MOIETY	269XH13919	1
Toxicodendron Pubescens Leaf	ACTIVE MOIETY	6IO182RP7A	1
Wood Creosote	ACTIVE MOIETY	3JYG22FD73	1
Sucrose	INACTIVE INGREDIENT	C151H8M554	1

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

Oral Care - Gingivitis
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, Slicea, Staphysag., Echinacea
Aconitum Napellus
Arnica Montana
Arsenic Trioxide
Arsenic Cation (3+)
Baptisia Tinctoria Root
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
Plantago Major
Toxicodendron Pubescens Leaf
Silicon Dioxide
Delphinium Staphisagria Seed
Echinacea, Unspecified
Sucrose

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-4441	55714-4441-1, 55714-4441-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Aconitum Napellus	U0NQ8555JD	ACTIB
Arnica Montana	O80TY208ZW	ACTIB
Arsenic Trioxide	S7V92P67HO	ACTIB
Baptisia Tinctoria Root	5EF0HWI5WU	ACTIB
Atropa Belladonna	WQZ3G9PF0H	ACTIB
Bryonia Alba Root	T7J046YI2B	ACTIB
Calendula Officinalis Flowering Top	18E7415PXQ	ACTIB
Matricaria Recutita	G0R4UBI2ZZ	ACTIB
Chelidonium Majus	7E889U5RNN	ACTIB
Crotalus Horridus Horridus Venom	YHA2XLJ956	ACTIB
Gelsemium Sempervirens Root	639KR60Q1Q	ACTIB
Calcium Sulfide	1MBW07J51Q	ACTIB
Wood Creosote	3JYG22FD73	ACTIB
Mercury	FXS1BY2PGL	ACTIB
Myrrh	JC71GJ1F3L	ACTIB
Strychnos Nux-vomica Seed	269XH13919	ACTIB
Phosphorus	27YLU75U4W	ACTIB
Plantago Major	W2469WNO6U	ACTIB
Toxicodendron Pubescens Leaf	6IO182RP7A	ACTIB
Silicon Dioxide	ETJ7Z6XBU4	ACTIB
Delphinium Staphisagria Seed	00543AP1JV	ACTIB
Echinacea, Unspecified	4N9P6CC1DX	ACTIB
Sucrose	C151H8M554	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 1 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sucrose	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, EMULSION / INTRAVENOUS		970 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / SUBLINGUAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / BUCCAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	DROPS / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED PELLETS / ORAL	59.8 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / SUBCUTANEOUS	47.75 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SUSPENSION / ORAL		40017 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION / ORAL		31885 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / TRANSMUCOSAL		1255 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION/ DROPS / ORAL		3750 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / INTRAVENOUS		1950 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / RECTAL	35.42 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii candidate 48 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
78a5ea44-c3e6-c43d-1ba8-43b141b9efc5			c6f22638-e6da-81fb-bfa6-d1668183fec0	2011-06-01	Warnings	Exact identifier spl id: 78a5ea44-c3e6-c43d-1ba8-43b141b9efc5 spl set id: c6f22638-e6da-81fb-bfa6-d1668183fec0

Reported adverse events (FAERS/openFDA)#

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