teeth and gums

Product NDC
69779-014
11-digit product format
697790014
Labeler code
69779
Product ID
69779-014_474c9df2-6434-569c-e063-6394a90a7707
Type
HUMAN OTC DRUG
Nonproprietary name
Calc Fluorica, Calc Phos, Ferrum Phos, Kali Phos, Mag Phos, Malus pumila, flos, Rock water, Ulex europaeus, flos
Dosage form
SPRAY
Route
ORAL
Labeler
Siddha Flower Essences LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-04-09
Substance
CALCIUM FLUORIDE; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MALUS DOMESTICA FLOWER; POTASSIUM PHOSPHATE, DIBASIC; TRIBASIC CALCIUM PHOSPHATE; ULEX EUROPAEUS FLOWER; WATER
Active strength
12; 12; 12; 5; 6; 12; 5; 5 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [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], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
teeth and gums
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM FLUORIDE12 [hp_X]/29.6mL
FERROSOFERRIC PHOSPHATE12 [hp_X]/29.6mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE12 [hp_X]/29.6mL
MALUS DOMESTICA FLOWER5 [hp_X]/29.6mL
POTASSIUM PHOSPHATE, DIBASIC6 [hp_X]/29.6mL
TRIBASIC CALCIUM PHOSPHATE12 [hp_X]/29.6mL
ULEX EUROPAEUS FLOWER5 [hp_X]/29.6mL
WATER5 [hp_X]/29.6mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO3B55K4YKI, 91GQH8I5F7, HF539G9L3Q, EF626V855K, CI71S98N1Z, 91D9GV0Z28, 398DBS1PXN, 059QF0KO0R

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
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6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
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7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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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

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
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM FLUORIDEACTIVE INGREDIENTO3B55K4YKITEETH AND GUMS (CALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
FERROSOFERRIC PHOSPHATEACTIVE INGREDIENT91GQH8I5F7TEETH AND GUMS (CALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEACTIVE INGREDIENTHF539G9L3QTEETH AND GUMS (CALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
MALUS DOMESTICA FLOWERACTIVE INGREDIENTEF626V855KTEETH AND GUMS (CALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
POTASSIUM PHOSPHATE, DIBASICACTIVE INGREDIENTCI71S98N1ZTEETH AND GUMS (CALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
TRIBASIC CALCIUM PHOSPHATEACTIVE INGREDIENT91D9GV0Z28TEETH AND GUMS (CALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
ULEX EUROPAEUS FLOWERACTIVE INGREDIENT398DBS1PXNTEETH AND GUMS (CALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
WATERACTIVE INGREDIENT059QF0KO0RTEETH AND GUMS (CALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBTEETH AND GUMS (CALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
FERROSOFERRIC PHOSPHATEACTIVE MOIETY91GQH8I5F7TEETH AND GUMS (CALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OTEETH AND GUMS (CALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838TEETH AND GUMS (CALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
MALUS DOMESTICA FLOWERACTIVE MOIETYEF626V855KTEETH AND GUMS (CALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
POTASSIUM CATIONACTIVE MOIETY295O53K152TEETH AND GUMS (CALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
ULEX EUROPAEUS FLOWERACTIVE MOIETY398DBS1PXNTEETH AND GUMS (CALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
WATERACTIVE MOIETY059QF0KO0RTEETH AND GUMS (CALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
LEMONINACTIVE INGREDIENT24RS0A988OTEETH AND GUMS (CALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
MUSA X PARADISIACA FLOWERINACTIVE INGREDIENTDG5B0M0NGYTEETH AND GUMS (CALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1
PINEAPPLEINACTIVE INGREDIENT2A88ZO081OTEETH AND GUMS (CALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69779-014TEETH AND GUMS (CALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOS) SPRAY [SIDDHA FLOWER ESSENCES LLC]3Current NDC, Legacy NDC, 2 package rows20220126_926c79d5-d270-4c0d-aca9-b58571c24f3a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69779-014-01697790014011 BOTTLE in 1 CARTON (69779-014-01) / 29.6 mL in 1 BOTTLE1 bottle2015-04-090000-00-00NoNoCurrent