D05
- Product NDC
- 63479-0405
- Requested package NDC
- 63479-0405-1
- 11-digit product format
- 634790405
- Labeler code
- 63479
- Product ID
- 63479-0405_0e76e858-e00d-c0d8-e063-6394a90a946b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- apis mellifera, asparagus, berberis vulgaris root bark, lytta vesicatoria, chelidonium majus, juniper berry, magnesium chloride, sodium chloride, populus tremuloides bark, rhus aromatica root bark, rubia tinctorum root, saw palmetto, solidago virgaurea flowering top, taraxacum officinale, and arctostaphylos uva-ursi leaf
- Dosage form
- SOLUTION
- Route
- SUBLINGUAL
- Labeler
- Apex Energetics Inc.
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 1993-03-15
- Substance
- APIS MELLIFERA; ASPARAGUS; BERBERIS VULGARIS ROOT BARK; LYTTA VESICATORIA; CHELIDONIUM MAJUS; JUNIPER BERRY; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; POPULUS TREMULOIDES BARK; RHUS AROMATICA ROOT BARK; RUBIA TINCTORUM ROOT; SAW PALMETTO; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; ARCTOSTAPHYLOS UVA-URSI LEAF
- Active strength
- 15; 1; 6; 15; 3; 6; 30; 30; 9; 2; 6; 2; 1; 2; 1 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
- Pharmacologic classes
- Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vegetable Proteins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- D05
- Brand name suffix
- KDNY-DRN
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| APIS MELLIFERA | 15 [hp_X]/mL |
| ASPARAGUS | 1 [hp_X]/mL |
| BERBERIS VULGARIS ROOT BARK | 6 [hp_X]/mL |
| LYTTA VESICATORIA | 15 [hp_X]/mL |
| CHELIDONIUM MAJUS | 3 [hp_X]/mL |
| JUNIPER BERRY | 6 [hp_X]/mL |
| MAGNESIUM CHLORIDE | 30 [hp_X]/mL |
| SODIUM CHLORIDE | 30 [hp_X]/mL |
| POPULUS TREMULOIDES BARK | 9 [hp_X]/mL |
| RHUS AROMATICA ROOT BARK | 2 [hp_X]/mL |
| RUBIA TINCTORUM ROOT | 6 [hp_X]/mL |
| SAW PALMETTO | 2 [hp_X]/mL |
| SOLIDAGO VIRGAUREA FLOWERING TOP | 1 [hp_X]/mL |
| TARAXACUM OFFICINALE | 2 [hp_X]/mL |
| ARCTOSTAPHYLOS UVA-URSI LEAF | 1 [hp_X]/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7S82P3R43Z | Internal UNII lookup |
| Z1EJP3037Z | Internal UNII lookup |
| 1TH8Q20J0U | Internal UNII lookup |
| 3Q034RO3BT | Internal UNII lookup |
| 7E889U5RNN | Internal UNII lookup |
| O84B5194RL | Internal UNII lookup |
| 02F3473H9O | Internal UNII lookup |
| 451W47IQ8X | Internal UNII lookup |
| 5543O0CEID | Internal UNII lookup |
| Q3H36W0J42 | Internal UNII lookup |
| 0SVP95L23G | Internal UNII lookup |
| J7WWH9M8QS | Internal UNII lookup |
| 5405K23S50 | Internal UNII lookup |
| 39981FM375 | Internal UNII lookup |
| 3M5V3D1X36 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 146800dc-bb1a-4d4c-803a-156a9fba600d | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63479-0405-1 | D05KDNY-DRN | 30 mL in 1 BOTTLE, GLASS | SOLUTION | 30 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63479-0405 | D05 KDNY-DRN (APIS MELLIFERA, ASPARAGUS, BERBERIS VULGARIS ROOT BARK, LYTTA VESICATORIA, CHELIDONIUM MAJUS, JUNIPER BERRY, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, POPULUS TREMULOIDES BARK, RHUS AROMATICA ROOT BARK, RUBIA TINCTORUM ROOT, SAW PALMETTO, SOLIDAGO VIRGAUREA FLOWERING TOP, TARAXACUM OFFICINALE, AND ARCTOSTAPHYLOS UVA-URSI LEAF) SOLUTION [APEX ENERGETICS INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240110_146800dc-bb1a-4d4c-803a-156a9fba600d.zip |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| D05 KDNY-DRN | APIS MELLIFERA, ASPARAGUS, BERBERIS VULGARIS ROOT BARK, LYTTA VESICATORIA, CHELIDONIUM MAJUS, JUNIPER BERRY, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, POPULUS TREMULOIDES BARK, RHUS AROMATICA ROOT BARK, RUBIA TINCTORUM ROOT, SAW PALMETTO, SOLIDAGO VIRGAUREA FLOWERING TOP, TARAXACUM OFFICINALE, AND ARCTOSTAPHYLOS UVA-URSI LEAF | Apex Energetics Inc. | 146800dc-bb1a-4d4c-803a-156a9fba600d | 2024-01-08 | Warnings | 63479-0405-1 63479-0405 63479040501 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63479-0405-1 | 63479040501 | 30 mL in 1 BOTTLE, GLASS (63479-0405-1) | 30 ml | 1993-03-15 | 0000-00-00 | No | No | Current |