OralSoothe
- Product NDC
- 68703-056
- 11-digit product format
- 687030056
- Labeler code
- 68703
- Product ID
- 68703-056_a7ce84ba-001a-4a0f-89a6-6f2689ccacbf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calc fluor, Calc phos, Chamomilla, Chamomilla, Passiflora
- Dosage form
- GRANULE
- Route
- ORAL
- Labeler
- Native Remedies, LLC
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2013-01-08
- Marketing end
- 0000-00-00
- Substance
- CALCIUM FLUORIDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP
- Active strength
- 8 [hp_X]/16mg; [hp_X]/16mg; [hp_X]/16mg; [hp_C]/16mg; [hp_X]/16mg
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68703-056-20 | OralSoothe | 20000 mg in 1 BOTTLE, GLASS | GRANULE | 20000 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CALCIUM FLUORIDE | ACTIVE INGREDIENT | O3B55K4YKI | ORALSOOTHE (CALC FLUOR, CALC PHOS, CHAMOMILLA, CHAMOMILLA, PASSIFLORA) GRANULE [NATIVE REMEDIES, LLC] | 1 | |
| MATRICARIA RECUTITA | ACTIVE INGREDIENT | G0R4UBI2ZZ | ORALSOOTHE (CALC FLUOR, CALC PHOS, CHAMOMILLA, CHAMOMILLA, PASSIFLORA) GRANULE [NATIVE REMEDIES, LLC] | 1 | |
| PASSIFLORA INCARNATA FLOWERING TOP | ACTIVE INGREDIENT | CLF5YFS11O | ORALSOOTHE (CALC FLUOR, CALC PHOS, CHAMOMILLA, CHAMOMILLA, PASSIFLORA) GRANULE [NATIVE REMEDIES, LLC] | 1 | |
| TRIBASIC CALCIUM PHOSPHATE | ACTIVE INGREDIENT | 91D9GV0Z28 | ORALSOOTHE (CALC FLUOR, CALC PHOS, CHAMOMILLA, CHAMOMILLA, PASSIFLORA) GRANULE [NATIVE REMEDIES, LLC] | 1 | |
| CALCIUM CATION | ACTIVE MOIETY | 2M83C4R6ZB | ORALSOOTHE (CALC FLUOR, CALC PHOS, CHAMOMILLA, CHAMOMILLA, PASSIFLORA) GRANULE [NATIVE REMEDIES, LLC] | 1 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | ORALSOOTHE (CALC FLUOR, CALC PHOS, CHAMOMILLA, CHAMOMILLA, PASSIFLORA) GRANULE [NATIVE REMEDIES, LLC] | 1 | |
| MATRICARIA RECUTITA | ACTIVE MOIETY | G0R4UBI2ZZ | ORALSOOTHE (CALC FLUOR, CALC PHOS, CHAMOMILLA, CHAMOMILLA, PASSIFLORA) GRANULE [NATIVE REMEDIES, LLC] | 1 | |
| PASSIFLORA INCARNATA FLOWERING TOP | ACTIVE MOIETY | CLF5YFS11O | ORALSOOTHE (CALC FLUOR, CALC PHOS, CHAMOMILLA, CHAMOMILLA, PASSIFLORA) GRANULE [NATIVE REMEDIES, LLC] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | ORALSOOTHE (CALC FLUOR, CALC PHOS, CHAMOMILLA, CHAMOMILLA, PASSIFLORA) GRANULE [NATIVE REMEDIES, LLC] | 1 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | ORALSOOTHE (CALC FLUOR, CALC PHOS, CHAMOMILLA, CHAMOMILLA, PASSIFLORA) GRANULE [NATIVE REMEDIES, LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ORALSOOTHE (CALC FLUOR, CALC PHOS, CHAMOMILLA, CHAMOMILLA, PASSIFLORA) GRANULE [NATIVE REMEDIES, LLC] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | ORALSOOTHE (CALC FLUOR, CALC PHOS, CHAMOMILLA, CHAMOMILLA, PASSIFLORA) GRANULE [NATIVE REMEDIES, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68703-056 | ORALSOOTHE (CALC FLUOR, CALC PHOS, CHAMOMILLA, CHAMOMILLA, PASSIFLORA) GRANULE [NATIVE REMEDIES, LLC] | 1 | Legacy NDC, 1 package rows | 20130109_8393be5c-a89a-4ca9-b2e5-44bcd5475194.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 68703-056-20 | 68703005620 | 20000 mg in 1 BOTTLE, GLASS | 20000 mg | Historical |