Oral Health

Product NDC
43742-1592
11-digit product format
437421592
Labeler code
43742
Product ID
43742-1592_6b4e2e0f-87a7-4816-8d63-6423ca6794c4
Type
HUMAN OTC DRUG
Nonproprietary name
Borax, Bryonia (Alba), Echinacea Purpurea, Juglans Cinerea, Kali Muriaticum, Magnesia Muriatica, Muriaticum Acidum, Discus Intervertebralis Suis, Oral Mucosa (Suis), Antimonium Crudum, Arsenicum Album, Bismuthum Subnitricum, Chamomilla, Cinchona Officinalis, Nux Moschata, Sambucus Nigra, Sepia, Mercurius Solubilis, Calcarea Phosphorica, Ignatia Amara, Oxygenium, Candida Albicans, Staphylococcus Aureus, Streptococcus Mutans
Dosage form
LIQUID
Route
ORAL
Labeler
Deseret Biologicals, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-02-19
Marketing end
2028-09-19
Substance
ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BISMUTH SUBNITRATE; BRYONIA ALBA ROOT; CANDIDA ALBICANS; CINCHONA OFFICINALIS BARK; ECHINACEA PURPUREA WHOLE; HYDROCHLORIC ACID; JUGLANS CINEREA BRANCH BARK/ROOT BARK; MAGNESIUM CHLORIDE; MATRICARIA CHAMOMILLA WHOLE; MERCURIUS SOLUBILIS; NUTMEG; OXYGEN; POTASSIUM CHLORIDE; SAMBUCUS NIGRA FLOWERING TOP; SEPIA OFFICINALIS JUICE; SODIUM BORATE; STAPHYLOCOCCUS AUREUS; STREPTOCOCCUS MUTANS; STRYCHNOS IGNATII SEED; SUS SCROFA INTERVERTEBRAL DISC; SUS SCROFA ORAL MUCOSA; TRIBASIC CALCIUM PHOSPHATE
Active strength
12; 12; 12; 6; 16; 12; 6; 6; 6; 6; 12; 12; 12; 16; 6; 12; 12; 6; 12; 12; 12; 8; 8; 12 [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_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Bismuth [CS], Bismuth [EPC], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Fungal Proteins [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Seed Storage Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Current FDA listing
Yes

openFDA Listing Details

Product ID
43742-1592_6b4e2e0f-87a7-4816-8d63-6423ca6794c4
SPL ID
6b4e2e0f-87a7-4816-8d63-6423ca6794c4
Product type
HUMAN OTC DRUG
Finished product
Yes
Brand name base
Oral Health
Generic name
Borax, Bryonia (Alba), Echinacea Purpurea, Juglans Cinerea, Kali Muriaticum, Magnesia Muriatica, Muriaticum Acidum, Discus Intervertebralis Suis, Oral Mucosa (Suis), Antimonium Crudum, Arsenicum Album, Bismuthum Subnitricum, Chamomilla, Cinchona Officinalis, Nux Moschata, Sambucus Nigra, Sepia, Mercurius Solubilis, Calcarea Phosphorica, Ignatia Amara, Oxygenium, Candida Albicans, Staphylococcus Aureus, Streptococcus Mutans
Dosage form
LIQUID
Route
ORAL
Marketing start
2020-02-19
Marketing end
2028-09-19
Marketing category
UNAPPROVED HOMEOPATHIC
Pharmacologic classes
Allergens [CS]; Bismuth [CS]; Bismuth [EPC]; Blood Coagulation Factor [EPC]; Calcium [CS]; Calculi Dissolution Agent [EPC]; Cations; Divalent [CS]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Food Additives [CS]; Fungal Proteins [CS]; Increased Coagulation Factor Activity [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]; Magnesium Ion Exchange Activity [MoA]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Fungal Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Phosphate Binder [EPC]; Phosphate Chelating Activity [MoA]; Plant Proteins [CS]; Potassium Compounds [CS]; Potassium Salt [EPC]; Seed Storage Proteins [CS]; Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

openFDA Active Ingredients

IngredientStrength
ANTIMONY TRISULFIDE12 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
BISMUTH SUBNITRATE12 [hp_X]/mL
BRYONIA ALBA ROOT6 [hp_X]/mL
CANDIDA ALBICANS16 [hp_X]/mL
CINCHONA OFFICINALIS BARK12 [hp_X]/mL
ECHINACEA PURPUREA WHOLE6 [hp_X]/mL
HYDROCHLORIC ACID6 [hp_X]/mL
JUGLANS CINEREA BRANCH BARK/ROOT BARK6 [hp_X]/mL
MAGNESIUM CHLORIDE6 [hp_X]/mL
MATRICARIA CHAMOMILLA WHOLE12 [hp_X]/mL
MERCURIUS SOLUBILIS12 [hp_X]/mL
NUTMEG12 [hp_X]/mL
OXYGEN16 [hp_X]/mL
POTASSIUM CHLORIDE6 [hp_X]/mL
SAMBUCUS NIGRA FLOWERING TOP12 [hp_X]/mL
SEPIA OFFICINALIS JUICE12 [hp_X]/mL
SODIUM BORATE6 [hp_X]/mL
STAPHYLOCOCCUS AUREUS12 [hp_C]/mL
STREPTOCOCCUS MUTANS12 [hp_C]/mL
STRYCHNOS IGNATII SEED12 [hp_X]/mL
SUS SCROFA INTERVERTEBRAL DISC8 [hp_X]/mL
SUS SCROFA ORAL MUCOSA8 [hp_X]/mL
TRIBASIC CALCIUM PHOSPHATE12 [hp_X]/mL

openFDA Harmonized Identifiers

FieldValues
UniiF79059A38U, S7V92P67HO, H19J064BA5, T7J046YI2B, 4D7G21HDBC, S003A158SB, QI7G114Y98, QTT17582CB, 48FZ1BHO18, 02F3473H9O, G0R4UBI2ZZ, 324Y4038G2, AEE24M3MQ9, S88TT14065, 660YQ98I10, CT03BSA18U, QDL83WN8C2, 91MBZ8H3QO, O478WX4004, 5C7J33MJJ1
Spl Set Id81ffb30f-5255-4e16-ba9d-b0de909aa557
Manufacturer NameDeseret Biologicals, Inc.

openFDA Package Details

Package NDCDescriptionMarketing startMarketing endSample
43742-1592-130 mL in 1 BOTTLE, DROPPER (43742-1592-1)2020-02-192028-09-19No

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
F79059A38UANTIMONY TRISULFIDE1345-04-6ANTIMONY TRISULFIDE
S7V92P67HOARSENIC TRIOXIDE1327-53-3ARSENIC TRIOXIDE
H19J064BA5BISMUTH SUBNITRATE1304-85-4BISMUTH SUBNITRATE
T7J046YI2BBRYONIA ALBA ROOTBRYONIA ALBA ROOT
4D7G21HDBCCANDIDA ALBICANSCANDIDA ALBICANS
S003A158SBCINCHONA OFFICINALIS BARKCINCHONA OFFICINALIS BARK
QTT17582CBHYDROCHLORIC ACID7647-01-0HYDROCHLORIC ACID
48FZ1BHO18JUGLANS CINEREA BRANCH BARK/ROOT BARKJUGLANS CINEREA BRANCH BARK/ROOT BARK
02F3473H9OMAGNESIUM CHLORIDE7791-18-6MAGNESIUM CHLORIDE
324Y4038G2MERCURIUS SOLUBILISMERCURIUS SOLUBILIS
AEE24M3MQ9NUTMEGNUTMEG
S88TT14065OXYGEN7782-44-7OXYGEN
660YQ98I10POTASSIUM CHLORIDE7447-40-7POTASSIUM CHLORIDE
CT03BSA18USAMBUCUS NIGRA FLOWERING TOPSAMBUCUS NIGRA FLOWERING TOP
QDL83WN8C2SEPIA OFFICINALIS JUICESEPIA OFFICINALIS JUICE
91MBZ8H3QOSODIUM BORATE1303-96-4SODIUM BORATE
O478WX4004STAPHYLOCOCCUS AUREUSSTAPHYLOCOCCUS AUREUS
5C7J33MJJ1STREPTOCOCCUS MUTANSSTREPTOCOCCUS MUTANS
1NM3M2487KSTRYCHNOS IGNATII SEEDSTRYCHNOS IGNATII SEED
OJ17O2WTSMSUS SCROFA INTERVERTEBRAL DISCSUS SCROFA INTERVERTEBRAL DISC
DUP6W562BMSUS SCROFA ORAL MUCOSASUS SCROFA ORAL MUCOSA
91D9GV0Z28TRIBASIC CALCIUM PHOSPHATE1306-06-5TRIBASIC CALCIUM PHOSPHATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43742-1592-14374215920130 mL in 1 BOTTLE, DROPPER (43742-1592-1) 30 ml2020-02-192028-09-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DRUG FACTS:Deseret Biologicals, Inc. | Apotheca Company2024-03-05HUMAN OTC DRUG LABEL4