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| Ingredient | Strength |
|---|
| ACONITUM NAPELLUS | 15 [hp_X]/mL |
| ARNICA MONTANA | 15 [hp_X]/mL |
| ARSENIC TRIOXIDE | 15 [hp_X]/mL |
| ATROPA BELLADONNA | 15 [hp_X]/mL |
| BAPTISIA TINCTORIA ROOT | 15 [hp_X]/mL |
| BRYONIA ALBA ROOT | 15 [hp_X]/mL |
| CALCIUM SULFIDE | 15 [hp_X]/mL |
| CALENDULA OFFICINALIS FLOWERING TOP | 15 [hp_X]/mL |
| CHELIDONIUM MAJUS | 15 [hp_X]/mL |
| CROTALUS HORRIDUS HORRIDUS VENOM | 15 [hp_X]/mL |
| DELPHINIUM STAPHISAGRIA SEED | 15 [hp_X]/mL |
| ECHINACEA, UNSPECIFIED | 6 [hp_X]/mL |
| GELSEMIUM SEMPERVIRENS ROOT | 15 [hp_X]/mL |
| MATRICARIA CHAMOMILLA | 15 [hp_X]/mL |
| MERCURY | 15 [hp_X]/mL |
| MYRRH | 15 [hp_X]/mL |
| PHOSPHORUS | 15 [hp_X]/mL |
| PHYTOLACCA AMERICANA ROOT | 15 [hp_X]/mL |
| PLANTAGO MAJOR | 15 [hp_X]/mL |
| SILICON DIOXIDE | 15 [hp_X]/mL |
| STRYCHNOS NUX-VOMICA SEED | 15 [hp_X]/mL |
| TOXICODENDRON PUBESCENS LEAF | 15 [hp_X]/mL |
| WOOD CREOSOTE | 15 [hp_X]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U0NQ8555JD, O80TY208ZW, S7V92P67HO, WQZ3G9PF0H, 5EF0HWI5WU, T7J046YI2B, 1MBW07J51Q, 18E7415PXQ, 7E889U5RNN, YHA2XLJ956, 00543AP1JV, 4N9P6CC1DX, 639KR60Q1Q, G0R4UBI2ZZ, FXS1BY2PGL, JC71GJ1F3L, 27YLU75U4W, 11E6VI8VEG, W2469WNO6U, ETJ7Z6XBU4 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55714-4789-1 | Oral Care-Gingivitis | 30 mL in 1 BOTTLE, GLASS | LIQUID | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55714-4789 | 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, SILICEA, STAPHYSAG., ECHINACEA) LIQUID [NEWTON LABORATORIES, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20201208_9971a7f4-c02c-02ba-e053-2a95a90a2b73.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55714-4789-1 | 55714478901 | 30 mL in 1 BOTTLE, GLASS (55714-4789-1) | 30 ml | 2019-09-02 | 0000-00-00 | No | No | Current |