Home NDC 55714-4789-1 Oral Care-Gingivitis
Product NDC 55714-4789
Requested package NDC 55714-4789-1
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55714-4789 55714-4789-1 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55714-4789 55714-4789-1 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 BAPTISIA TINCTORIA ROOT 15 [hp_X]/mL ATROPA BELLADONNA 15 [hp_X]/mL BRYONIA ALBA ROOT 15 [hp_X]/mL CALENDULA OFFICINALIS FLOWERING TOP 15 [hp_X]/mL MATRICARIA CHAMOMILLA 15 [hp_X]/mL CHELIDONIUM MAJUS 15 [hp_X]/mL CROTALUS HORRIDUS HORRIDUS VENOM 15 [hp_X]/mL GELSEMIUM SEMPERVIRENS ROOT 15 [hp_X]/mL CALCIUM SULFIDE 6 [hp_X]/mL WOOD CREOSOTE 15 [hp_X]/mL MERCURY 15 [hp_X]/mL MYRRH 15 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED 15 [hp_X]/mL PHOSPHORUS 15 [hp_X]/mL PHYTOLACCA AMERICANA ROOT 15 [hp_X]/mL PLANTAGO MAJOR 15 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF 15 [hp_X]/mL SILICON DIOXIDE 15 [hp_X]/mL DELPHINIUM STAPHISAGRIA SEED 15 [hp_X]/mL ECHINACEA, UNSPECIFIED 15 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 2 · 23 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
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 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 Newton Laboratories, Inc. 9971a7f4-c02c-02ba-e053-2a95a90a2b73 2020-12-04 Warnings Exact identifier ndc (package): 55714-4789-1 ndc (product): 55714-4789 ndc11 (package): 55714478901
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