Label: DENTAL PAIN (aceticum acidum, calendula officinalis, zingiber officinale, bryonia- alba, coffea tosta, ledum palustre, phosphorus, plantago major, spigelia anthelmia, arnica montana, chamomilla, hepar sulphuris calcareum, hypericum perforatum, aconitum napellus, antimonium crudum, mezereum, sepia, staphysagria, magnesia phosphorica liquid

  • NDC Code(s): 43742-1523-1
  • Packager: Deseret Biologicals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated January 14, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS:

    Aceticum Acidum 3X, Calendula Officinalis 3X, Zingiber Officinale 3X, Bryonia (Alba) 6X, Coffea Tosta 6X, Ledum Palustre 6X, Phosphorus 6X, Plantago Major 6X, Spigelia Anthelmia 6X, Arnica Montana 6X, 12X, 18X, 30X,Chamomilla 6X, 12X, 18X, 30X, Hepar Sulphuris Calcareum 8X, Hypericum Perforatum 8X, 12X, 18X, 30X, Aconitum Napellus 12X, Antimonium Crudum 12X, Mezereum 12X, Sepia 12X, Staphysagria 12X, 18X, 24X, 30X, Magnesia Phosphorica 12X, 30X.

  • HOMEOPATHIC INDICATIONS:

    For the temporary relief of symptoms related to dental pain, such as sensitive teeth, cramping of jaw, generalized dental discomfort, sensitivity to temperature, brushing or salivation.**

    **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

  • WARNINGS:

    Keep out of reach of children. In case of overdose, Contact physician or Poison Control Center right away.

    If pregnant or breast-feeding, seek advice of a health professional before use.

    Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.

  • DIRECTIONS:

    1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

  • HOMEOPATHIC INDICATIONS:

    For the temporary relief of symptoms related to dental pain, such as sensitive teeth, cramping of jaw, generalized dental discomfort, sensitivity to temperature, brushing or salivation.**

    **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol.

  • QUESTIONS:

    Dist. By: Deseret Biologicals, Inc.

    469 W. Parkland Drive

    Sandy, UT 84070 www.desbio.com

  • PACKAGE LABEL DISPLAY:

    DESBIO
    NDC 43742-1523-1
    HOMEOPATHIC
    DENTAL
    PAIN
    1 FL OZ (30 ml)

    Dental Pain

  • INGREDIENTS AND APPEARANCE
    DENTAL PAIN 
    aceticum acidum, calendula officinalis, zingiber officinale, bryonia (alba), coffea tosta, ledum palustre, phosphorus, plantago major, spigelia anthelmia, arnica montana, chamomilla, hepar sulphuris calcareum, hypericum perforatum, aconitum napellus, antimonium crudum, mezereum, sepia, staphysagria, magnesia phosphorica liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43742-1523
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P) ACETIC ACID3 [hp_X]  in 1 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]  in 1 mL
    GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER3 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mL
    COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E) (COFFEA ARABICA SEED, ROASTED - UNII:9H58JRT35E) COFFEA ARABICA SEED, ROASTED6 [hp_X]  in 1 mL
    RHODODENDRON TOMENTOSUM LEAFY TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) RHODODENDRON TOMENTOSUM LEAFY TWIG6 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS6 [hp_X]  in 1 mL
    PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR6 [hp_X]  in 1 mL
    SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE) SPIGELIA ANTHELMIA6 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_X]  in 1 mL
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE8 [hp_X]  in 1 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM8 [hp_X]  in 1 mL
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS12 [hp_X]  in 1 mL
    ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE12 [hp_X]  in 1 mL
    DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK12 [hp_X]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE12 [hp_X]  in 1 mL
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED12 [hp_X]  in 1 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43742-1523-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/21/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/21/2019
    Labeler - Deseret Biologicals, Inc. (940741853)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43742-1523) , api manufacture(43742-1523) , label(43742-1523) , pack(43742-1523)