FDA.reportPublic FDA data

oral health

Manufacturer
Siddha Flower Essences LLC | Samson Pharmaceuticals, Inc.
Effective date
2015-04-09
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:06:40

Label at a glance#

Productoral health
Active ingredientCALCIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE, POTASSIUM PHOSPHATE, DIBASIC, MALUS DOMESTICA FLOWER, SODIUM SULFATE, WATER, SILICON DIOXIDE, ULEX EUROPAEUS FLOWER
Label structure10 sections

Dosage and administration

pets 31 lbs and heavier 5 sprays in mouth twice per day 5 days per week pets 30 lbs and lighter 3 sprays in mouth twice per day 5 days per week may be sprayed into pet's water bowl may be applied externally to the top of pet's head

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 Fluor 12X HPUS

Calc Phos 12X HPUS

Kali Phos 6X HPUS

Malus pumila, flos (Crab Apple) 5X HPUS

Nat Sulph 6X HPUS

Rock Water (Rock Water) 5X HPUS

Silicea 12X HPUS

Ulex europaeus, flos (Gorse) 5X HPUS

Purpose

OTC - PURPOSE SECTION

Each dose contains equal parts of:

Calc Fluor 12X HPUS.....................................deficient teeth enamel; tooth ache; teeth become loose

Calc Phos 12X HPUS....................................rapid decay of teeth

Kali Phos 6X HPUS......................................offensive oder from mouth; gums bleed easily

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

Nat Sulph 6X HPUS......................................salivates after meals; dryness with redness of gums

Rock Water (Rock Water) 5X HPUS...............strong desire for self-perfection

Silicea 12X HPUS........................................bad breath in morning

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

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

Purpose

INDICATIONS & USAGE SECTION

  • temporarily relieves symptoms of
  • tooth decay
  • toothache
  • bleeding gums
  • bad breath


indications are based on homeopathic materia medica, not clinical tests.

Warnings

WARNINGS SECTION

Stop use and ask a veterinarian if symptoms persist or worsen

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

pets 31 lbs and heavier

5 sprays in mouth twice per day 5 days per week

pets 30 lbs and lighter
3 sprays in mouth twice per day 5 days per week

  • may be sprayed into pet's water bowl
  • may be applied externally to the top of pet's head

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 and Structured 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 for Siddha Flower Essences
Malibu, CA 90265

Made in USA

Side Panel

DESCRIPTION SECTION

flower essences and homeopathy:

  •    Jump start your pet'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 and structured water with natural preservatives
  •    Blends time-tested natural medicine with modern technology
  •    4 - 6 week supply depending on pet's weight


siddha pets
calm down
abandonment and separation
temperament and boundaries
oral health

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100% natural     -     no alcohol

siddha cell salts + flower essences

pets

oral health

Toothache and Decay
Bleeding Gums
Bad Breath




Homeopathic Remedy
1 US fl oz (29.6mL)

Oral Health CartonOral Health Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69779-023-01oral health1 in 1 CARTONSPRAY11
69779-023-01oral health29.6 mL in 1 BOTTLESPRAY29.61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69779-023ORAL HEALTH (CALC FLUOR, CALC PHOS, KALI PHOS, MALUS PUMILA, FLOS, NAT SULPH, ROCK WATER, SILICEA, ULEX EUROPAEUS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]12 package rows20150513_e35acb33-27de-4eaa-a530-036d2c727d35.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM FLUORIDEACTIVE INGREDIENTO3B55K4YKI1
MALUS DOMESTICA FLOWERACTIVE INGREDIENTEF626V855K1
POTASSIUM PHOSPHATE, DIBASICACTIVE INGREDIENTCI71S98N1Z1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU41
SODIUM SULFATEACTIVE INGREDIENT0YPR65R21J1
TRIBASIC CALCIUM PHOSPHATEACTIVE INGREDIENT91D9GV0Z281
ULEX EUROPAEUS FLOWERACTIVE INGREDIENT398DBS1PXN1
WATERACTIVE INGREDIENT059QF0KO0R1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB1
FLUORIDE IONACTIVE MOIETYQ80VPU408O1
MALUS DOMESTICA FLOWERACTIVE MOIETYEF626V855K1
POTASSIUM CATIONACTIVE MOIETY295O53K1521
SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU41
SODIUM SULFATE ANHYDROUSACTIVE MOIETY36KCS0R7501
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
69779-02369779-023-01

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
CALCIUM FLUORIDEO3B55K4YKIACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
POTASSIUM PHOSPHATE, DIBASICCI71S98N1ZACTIB
MALUS DOMESTICA FLOWEREF626V855KACTIB
SODIUM SULFATE0YPR65R21JACTIB
WATER059QF0KO0RACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
ULEX EUROPAEUS FLOWER398DBS1PXNACTIB
MUSA X PARADISIACA FLOWERDG5B0M0NGYIACT
LEMON24RS0A988OIACT
PINEAPPLE2A88ZO081OIACT

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 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PINEAPPLEPINEAPPLE2A88ZO081OPOWDER, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
2 equally ranked IID candidates
PINEAPPLEPINEAPPLE2A88ZO081OCONCENTRATE / ORAL1 mg/1mlExact identifier — unii candidate
2 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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CALC FLUOR 6XCALCIUM FLUORIDEHyland's Inc.dbed54cc-12ec-0a73-e053-2a95a90a8cc22025-04-10WarningsName fallback
generic name: CALCIUM FLUORIDE
D-121CALCIUM FLUORIDEDNA Labs, Inc.5495bfae-4080-4506-b16e-0c777faabcbb2025-01-13WarningsName fallback
generic name: CALCIUM FLUORIDE
Oral HealthANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, BORAX, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CHAMOMILLA, CINCHONA OFFICINALIS, DISCUS INTERVERTEBRALIS SUIS, STREPTOCOCCUS DYSGALACTIAE DNA, STREPTOCOCCUS MUTANS DNA, STREPTOCOCCUS PNEUMONIAE DNA, ECHINACEA PURPUREA, IGNATIA AMARA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NUX MOSCHATA, ORAL MUCOSA (SUIS), OXYGENIUM, SAMBUCUS NIGRA, SEPIA, STAPHYLOCOCCUS AUREUS,Deseret Biologicals, Inc.6f66ff40-6e0e-4a35-963c-965c65df76eb2024-04-01WarningsName fallback
brand name: Oral Health
Oral HealthBORAX, 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 MUTANSDeseret Biologicals, Inc.81ffb30f-5255-4e16-ba9d-b0de909aa5572024-03-05WarningsName fallback
brand name: Oral Health
Calcarea fluoricaCALCIUM FLUORIDEBoiron848d876f-6e07-a62d-e053-2a91aa0ad5de2023-11-09Name fallback
generic name: CALCIUM FLUORIDE
Calcarea fluoricaCALCIUM FLUORIDEBoiron8504b8ca-20a8-36b5-e053-2991aa0a84982023-11-09Name fallback
generic name: CALCIUM FLUORIDE
Calcarea fluoricaCALCIUM FLUORIDEBoiron848c9e6f-e79f-31f9-e053-2a91aa0a582f2023-11-09Name fallback
generic name: CALCIUM FLUORIDE
Calcarea fluoricaCALCIUM FLUORIDEBoiron8504c51c-08e7-1287-e053-2991aa0a0e482023-11-09Name fallback
generic name: CALCIUM FLUORIDE
Calcarea fluoricaCALCIUM FLUORIDEBoironb3d40710-79fe-11e6-aeeb-424c583030312023-08-29Name fallback
generic name: CALCIUM FLUORIDE
Calcarea fluoricaCALCIUM FLUORIDEBoiron849b4a6a-07b1-23c4-e053-2991aa0a9d522023-04-11Name fallback
generic name: CALCIUM FLUORIDE
Calcarea fluoricaCALCIUM FLUORIDEBoiron8504bb16-4ad4-2732-e053-2991aa0affd12023-04-11Name fallback
generic name: CALCIUM FLUORIDE
Calcarea fluoricaCALCIUM FLUORIDEBoiron848cf5d3-3da0-a19c-e053-2991aa0af4692023-03-27Name fallback
generic name: CALCIUM FLUORIDE
Calcarea fluoricaCALCIUM FLUORIDEBoiron8504f489-e24f-da04-e053-2991aa0ae2f52023-02-20Name fallback
generic name: CALCIUM FLUORIDE
Calcarea fluoricaCALCIUM FLUORIDEBoiron848d0c48-cdbf-7eb8-e053-2a91aa0a6ea92023-02-20Name fallback
generic name: CALCIUM FLUORIDE
Calcarea fluoricaCALCIUM FLUORIDEBoiron85050709-a288-5291-e053-2a91aa0ae16b2023-01-23Name fallback
generic name: CALCIUM FLUORIDE
Calcarea fluoricaCALCIUM FLUORIDEBoiron849b6e1c-ed2b-5852-e053-2a91aa0ac5472023-01-20Name fallback
generic name: CALCIUM FLUORIDE
CALCAREA FLUORICA 6XCALCIUM FLUORIDESeroyal USA0ebdb790-3ec2-3f4b-e054-00144ff8d46c2021-07-14WarningsName fallback
generic name: CALCIUM FLUORIDE

Reported adverse events (FAERS/openFDA)#

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