FDA.reportPublic FDA data

teeth and gums

Manufacturer
Siddha Flower Essences LLC
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:36:34

Label at a glance#

Productteeth and gums
Active ingredientCALCIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE, FERROSOFERRIC PHOSPHATE, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, MALUS DOMESTICA FLOWER, WATER, ULEX EUROPAEUS FLOWER
Label structure10 sections

Indications and uses

temporarily relieves symptoms of sensitive teeth toothache bleeding gums inflamed gums brittle dental enamel offensive breath indications are based on homeopathic materia medica, not clinical tests

Dosage and administration

spray in mouth, swish for 5-10 seconds and then swallow best if used after brushing teeth or flossing use 5 days per week until symptoms are relieved adults and children 12 years and over 4-5 sprays per dose children 2 years to under 12 years 2-3 sprays per dose children under 2 years consult a doctor

Storage and handling

do not use if plastic seal around cap is broken or missing. store in a cool, dry place.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Each dose contains equal parts of:


Calc Fluorica 12X HPUS

Calc Phos 12X HPUS

Ferrum Phos 12X HPUS

Kali Phos 6X HPUS

Mag Phos 12X HPUS

Malus pumila, flos (Crab Apple) 5X HPUS

Rock water 5X HPUS

Ulex europaeus, flos (Gorse) 5X HPUS

Purpose

OTC - PURPOSE SECTION

Each dose contains equal parts of:

Calc Fluorica 12X HPUS.................................deficient enamel of teeth; brittle enamel; toothache aggravated by food

Calc Phos 12X HPUS.....................................rapid decay of teeth; inflamed gums; sensitive teeth; tingling toothache

Ferrum Phos 12X HPUS.................................toothache

Kali Phos 6X HPUS.......................................bleeding gums; aching teeth; toothache with bleeding gums; water cankers; offensive breath

Mag Phos 12X HPUS.....................................sensitive teeth; shooting toothache

Malus pumila, flos (Crab Apple) 5X HPUS........feeling unclean inside and out

Rock water 5X HPUS.....................................strong desire for perfection

Ulex europaeus, flos (Gorse) 5X HPUS............stagnation has taken hold

The letters HPUS indicate that these ingredients are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves symptoms of
  • sensitive teeth
  • toothache
  • bleeding gums
  • inflamed gums
  • brittle dental enamel
  • offensive breath


indications are based on homeopathic materia medica, not clinical tests

Warnings

WARNINGS SECTION

Stop use and ask a doctor if symptoms persist or worsen

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

  • spray in mouth, swish for 5-10 seconds and then swallow
  • best if used after brushing teeth or flossing
  • use 5 days per week until symptoms are relieved

adults and children 12 years and over

4-5 sprays per dose

children 2 years to under 12 years

2-3 sprays per dose

children under 2 years
consult a doctor

Other Information

STORAGE AND HANDLING SECTION

  • do not use if plastic seal around cap is broken or missing.
  • store in a cool, dry place.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Banana*, Floss Flower*, Lemon*, Natural Flavor, Pineapple*, Purified Water, Snapdragon*, Venus Fly Trap*


*flower essence

DESCRIPTION SECTION

Questions or Comments?

Call 800.570.0021

Between 9am-5pm PST

info@siddhaflowers.com

siddhaflowers.com

MFD by Siddha Flower Essences
Oxnard, CA 93030

Made in USA

Side Panel

DESCRIPTION SECTION

flower essences and homeopathy:

  •    Jump start your body's natural ability to heal
  •    Natural, safe and non-habit forming
  •    No contraindications.  May be effectively used with drugs and other supplements
  •    Alcohol, sugar, dairy and gluten free
  • Prepared in purified water with natural preservatives
  •    Blends time-tested natural medicine with modern technology
  •    One month supply




FOUNDATIONAL REMEDIES
may be used with targeted remedies

stress relief
daily alignment

emotional detox
deep-seated stress

TARGETED REMEDIES
sleep                                    male balance
healthy hair                           blood sugar
female balance                      lung and sinus
muscles and joints                 throat and voice
youthful skin                          teeth and gums
happy heart                          hearing
digestion                               sight

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Teeth & GumsTeeth & Gums

non GMO - no alcohol



siddha cell salts + flower essences



teeth and gums



Sensitive Teeth

Toothache

Inflamed Gums



sugar, dairy and gluten free



Homeopathic Remedy

1 US fl oz (29.6mL)

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130897186002122GTIN-13: 0897186002122
EAN-13: 0897186002122
GTIN-12: 897186002122
UPC-A: 897186002122
GTIN storage (14 digits): 00897186002122		Teeth_Gums_2024_Final.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69779-014-012026-01-01C16284748780-11030e365-41e0-111a-e063-dadaa90a10e2Drug Facts
69779-014-012024-01-30C16284748780-11030e365-41e0-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69779-014-01teeth and gums1 in 1 CARTONSPRAY14
69779-014-01teeth and gums29.6 mL in 1 BOTTLESPRAY29.64

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM FLUORIDEACTIVE INGREDIENTO3B55K4YKI1
FERROSOFERRIC PHOSPHATEACTIVE INGREDIENT91GQH8I5F71
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEACTIVE INGREDIENTHF539G9L3Q1
MALUS DOMESTICA FLOWERACTIVE INGREDIENTEF626V855K1
POTASSIUM PHOSPHATE, DIBASICACTIVE INGREDIENTCI71S98N1Z1
TRIBASIC CALCIUM PHOSPHATEACTIVE INGREDIENT91D9GV0Z281
ULEX EUROPAEUS FLOWERACTIVE INGREDIENT398DBS1PXN1
WATERACTIVE INGREDIENT059QF0KO0R1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB1
FERROSOFERRIC PHOSPHATEACTIVE MOIETY91GQH8I5F71
FLUORIDE IONACTIVE MOIETYQ80VPU408O1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8381
MALUS DOMESTICA FLOWERACTIVE MOIETYEF626V855K1
POTASSIUM CATIONACTIVE MOIETY295O53K1521
ULEX EUROPAEUS FLOWERACTIVE MOIETY398DBS1PXN1
WATERACTIVE MOIETY059QF0KO0R1
LEMONINACTIVE INGREDIENT24RS0A988O1
MUSA X PARADISIACA FLOWERINACTIVE INGREDIENTDG5B0M0NGY1
PINEAPPLEINACTIVE INGREDIENT2A88ZO081O1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69779-01469779-014-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
MUSA X PARADISIACA FLOWERDG5B0M0NGYIACT
LEMON24RS0A988OIACT
PINEAPPLE2A88ZO081OIACT
CALCIUM FLUORIDEO3B55K4YKIACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
POTASSIUM PHOSPHATE, DIBASICCI71S98N1ZACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
MALUS DOMESTICA FLOWEREF626V855KACTIB
WATER059QF0KO0RACTIB
ULEX EUROPAEUS FLOWER398DBS1PXNACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PINEAPPLEPINEAPPLE2A88ZO081OPOWDER, FOR SUSPENSION / ORAL120 mgExact identifier — unii+route
4 equally ranked IID candidates
PINEAPPLEPINEAPPLE2A88ZO081OCONCENTRATE / ORAL1 mg/1mlExact identifier — unii+route
4 equally ranked IID candidates
PINEAPPLEPINEAPPLE2A88ZO081OPOWDER, FOR SUSPENSION / ORAL120 mgExact identifier — unii+route
4 equally ranked IID candidates
PINEAPPLEPINEAPPLE2A88ZO081OCONCENTRATE / ORAL1 mg/1mlExact identifier — unii+route
4 equally ranked IID candidates

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
ndc (package): 69779-014-01
ndc (product): 69779-014
ndc11 (package): 69779001401
spl id: 474c9df2-6434-569c-e063-6394a90a7707
spl set id: 926c79d5-d270-4c0d-aca9-b58571c24f3a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.