NDC 68703-056

OralSoothe

Calc Fluor, Calc Phos, Chamomilla, Chamomilla, Passiflora

OralSoothe is a Oral Granule in the Human Otc Drug category. It is labeled and distributed by Native Remedies, Llc. The primary component is Calcium Fluoride; Tribasic Calcium Phosphate; Matricaria Recutita; Matricaria Recutita; Passiflora Incarnata Flowering Top.

Product ID68703-056_a7ce84ba-001a-4a0f-89a6-6f2689ccacbf
NDC68703-056
Product TypeHuman Otc Drug
Proprietary NameOralSoothe
Generic NameCalc Fluor, Calc Phos, Chamomilla, Chamomilla, Passiflora
Dosage FormGranule
Route of AdministrationORAL
Marketing Start Date2013-01-08
Marketing CategoryUNAPPROVED HOMEOPATHIC / UNAPPROVED HOMEOPATHIC
Labeler NameNative Remedies, LLC
Substance NameCALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP
Active Ingredient Strength8 [hp_X]/16mg; [hp_X]/16mg; [hp_X]/16mg; [hp_C]/16mg; [hp_X]/16mg
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 68703-056-20

20000 mg in 1 BOTTLE, GLASS (68703-056-20)
Marketing Start Date2013-01-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68703-056-20 [68703005620]

OralSoothe GRANULE
Marketing Categoryunapproved homeopathic
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-01-08
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CALCIUM FLUORIDE8 [hp_X]/16mg

OpenFDA Data

SPL SET ID:8393be5c-a89a-4ca9-b2e5-44bcd5475194
Manufacturer
UNII
UPC Code
  • 0810845014649

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