Oral Care-Gingivitis

Product NDC
55714-4789
11-digit product format
557144789
Labeler code
55714
Product ID
55714-4789_b5abd43f-3366-a1ae-e053-2995a90ae92b
Type
HUMAN OTC DRUG
Nonproprietary name
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
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-09-02
Substance
ACONITUM NAPELLUS; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BRYONIA ALBA ROOT; CALCIUM SULFIDE; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DELPHINIUM STAPHISAGRIA SEED; ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA CHAMOMILLA; MERCURY; MYRRH; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PLANTAGO MAJOR; SILICON DIOXIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; WOOD CREOSOTE
Active strength
15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oral Care-Gingivitis
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS15 [hp_X]/mL
ARNICA MONTANA15 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_X]/mL
ATROPA BELLADONNA15 [hp_X]/mL
BAPTISIA TINCTORIA ROOT15 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
CALCIUM SULFIDE15 [hp_X]/mL
CALENDULA OFFICINALIS FLOWERING TOP15 [hp_X]/mL
CHELIDONIUM MAJUS15 [hp_X]/mL
CROTALUS HORRIDUS HORRIDUS VENOM15 [hp_X]/mL
DELPHINIUM STAPHISAGRIA SEED15 [hp_X]/mL
ECHINACEA, UNSPECIFIED6 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]/mL
MATRICARIA CHAMOMILLA15 [hp_X]/mL
MERCURY15 [hp_X]/mL
MYRRH15 [hp_X]/mL
PHOSPHORUS15 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT15 [hp_X]/mL
PLANTAGO MAJOR15 [hp_X]/mL
SILICON DIOXIDE15 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF15 [hp_X]/mL
WOOD CREOSOTE15 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU0NQ8555JD, O80TY208ZW, S7V92P67HO, WQZ3G9PF0H, 5EF0HWI5WU, T7J046YI2B, 1MBW07J51Q, 18E7415PXQ, 7E889U5RNN, YHA2XLJ956, 00543AP1JV, 4N9P6CC1DX, 639KR60Q1Q, G0R4UBI2ZZ, FXS1BY2PGL, JC71GJ1F3L, 27YLU75U4W, 11E6VI8VEG, W2469WNO6U, ETJ7Z6XBU4

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
55714-4789-1Oral Care-Gingivitis30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4789ORAL 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, SILICEA, STAPHYSAG., ECHINACEA) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201208_9971a7f4-c02c-02ba-e053-2a95a90a2b73.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-4789-15571447890130 mL in 1 BOTTLE, GLASS (55714-4789-1) 30 ml2019-09-020000-00-00NoNoCurrent