E08
- Product NDC
- 63479-0508
- Requested package NDC
- 63479-0508-1
- 11-digit product format
- 634790508
- Labeler code
- 63479
- Product ID
- 63479-0508_0e76f0d9-0ac3-e097-e063-6394a90adba2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- BETULA VERRUCOSA, BOS TAURUS ADRENAL GLAND, BOS TAURUS PITUITARUM POSTERIUM, CALCAREA IODATA, COCCULUS INDICUS, COLCHICUM AUTUMNALE, ELEUTHERO, EUROPEAN HORNBEAM FLOWER, EUROPEAN OLIVE, HYPOTHALAMUS, JUNIPERUS COMMUNIS STEM, KALI CARBONICUM, KALI PHOSPHORICUM, LAC CANINUM, NUX VOMICA, PASSIFLORA INCARNATA, ORNITHOGALUM UMBELLATUM, PHOSPHORICUM ACIDUM, RHAMNUS PURSHIANA, RIBES NIGRUM, SARCOLACTICUM ACIDUM, SEPIA, SOLIDAGO VIRGAUREA, SUS SCROFA PINEAL GLAND, TRYPTOPHAN, TYROSINE, YELLOW JASMINE
- Dosage form
- SOLUTION/ DROPS
- Route
- SUBLINGUAL
- Labeler
- Apex Energetics Inc.
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 1988-08-15
- Substance
- ANAMIRTA COCCULUS SEED; BETULA PENDULA LEAF; BOS TAURUS ADRENAL GLAND; BOS TAURUS HYPOTHALAMUS; BOS TAURUS PITUITARY GLAND; CALCIUM IODIDE; CANIS LUPUS FAMILIARIS MILK; CARPINUS BETULUS FLOWER; COLCHICUM AUTUMNALE BULB; ELEUTHERO; FRANGULA PURSHIANA BARK; GELSEMIUM SEMPERVIRENS ROOT; JUNIPERUS COMMUNIS STEM; LACTIC ACID, L-; OLEA EUROPAEA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PASSIFLORA INCARNATA TOP; PHOSPHORIC ACID; POTASSIUM CARBONATE; POTASSIUM PHOSPHATE, DIBASIC; RIBES NIGRUM FLOWER BUD; SEPIA OFFICINALIS JUICE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PINEAL GLAND; TRYPTOPHAN; TYROSINE
- Active strength
- 12; 6; 4; 7; 7; 12; 15; 30; 12; 9; 6; 15; 9; 30; 30; 30; 12; 12; 12; 30; 8; 30; 9; 30; 4; 7; 7 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
- Pharmacologic classes
- Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC], Seed Storage Proteins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- E08
- Brand name suffix
- BIOCLOCK REGULATOR
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CARPINUS BETULUS FLOWER | 12 [hp_X]/mL |
| OLEA EUROPAEA FLOWER | 6 [hp_X]/mL |
| GELSEMIUM SEMPERVIRENS ROOT | 4 [hp_C]/mL |
| ANAMIRTA COCCULUS SEED | 7 [hp_C]/mL |
| BOS TAURUS HYPOTHALAMUS | 7 [hp_C]/mL |
| JUNIPERUS COMMUNIS STEM | 12 [hp_X]/mL |
| PHOSPHORIC ACID | 15 [hp_X]/mL |
| LACTIC ACID, L- | 30 [hp_X]/mL |
| SEPIA OFFICINALIS JUICE | 12 [hp_X]/mL |
| POTASSIUM CARBONATE | 9 [hp_X]/mL |
| POTASSIUM PHOSPHATE, DIBASIC | 6 [hp_X]/mL |
| TYROSINE | 15 [hp_X]/mL |
| SOLIDAGO VIRGAUREA FLOWERING TOP | 9 [hp_X]/mL |
| ORNITHOGALUM UMBELLATUM FLOWERING TOP | 30 [hp_X]/mL |
| FRANGULA PURSHIANA BARK | 30 [hp_X]/mL |
| PASSIFLORA INCARNATA TOP | 30 [hp_X]/mL |
| SUS SCROFA PINEAL GLAND | 12 [hp_X]/mL |
| BETULA PENDULA LEAF | 12 [hp_X]/mL |
| CALCIUM IODIDE | 12 [hp_X]/mL |
| CANIS LUPUS FAMILIARIS MILK | 30 [hp_X]/mL |
| BOS TAURUS ADRENAL GLAND | 8 [hp_X]/mL |
| BOS TAURUS PITUITARY GLAND | 30 [hp_X]/mL |
| RIBES NIGRUM FLOWER BUD | 9 [hp_X]/mL |
| TRYPTOPHAN | 30 [hp_X]/mL |
| ELEUTHERO | 4 [hp_C]/mL |
| STRYCHNOS NUX-VOMICA SEED | 7 [hp_C]/mL |
| COLCHICUM AUTUMNALE BULB | 7 [hp_C]/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 07YL55QKZ9 | Internal UNII lookup |
| 498M34P1VZ | Internal UNII lookup |
| 639KR60Q1Q | Internal UNII lookup |
| 810258W28U | Internal UNII lookup |
| S6G2NLH4Y7 | Internal UNII lookup |
| HBU87MH6OY | Internal UNII lookup |
| E4GA8884NN | Internal UNII lookup |
| F9S9FFU82N | Internal UNII lookup |
| QDL83WN8C2 | Internal UNII lookup |
| BQN1B9B9HA | Internal UNII lookup |
| CI71S98N1Z | Internal UNII lookup |
| 42HK56048U | Internal UNII lookup |
| 5405K23S50 | Internal UNII lookup |
| CZD6M4PY4B | Internal UNII lookup |
| 4VBP01X99F | Internal UNII lookup |
| CLF5YFS11O | Internal UNII lookup |
| 050QZ2EDK7 | Internal UNII lookup |
| 5HW39H9KDH | Internal UNII lookup |
| 8EKI9QEE2H | Internal UNII lookup |
| G39P120JQT | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| bf77d8e4-cf1c-447f-e053-2995a90a8c6f | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63479-0508-1 | E08BIOCLOCK REGULATOR | 30 mL in 1 BOTTLE, GLASS | SOLUTION/ DROPS | 30 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63479-0508 | E08 BIOCLOCK REGULATOR (BETULA VERRUCOSA, BOS TAURUS ADRENAL GLAND, BOS TAURUS PITUITARUM POSTERIUM, CALCAREA IODATA, COCCULUS INDICUS, COLCHICUM AUTUMNALE, ELEUTHERO, EUROPEAN HORNBEAM FLOWER, EUROPEAN OLIVE, HYPOTHALAMUS, JUNIPERUS COMMUNIS STEM, KALI CARBONICUM, KALI PHOSPHORICUM, LAC CANINUM, NUX VOMICA, PASSIFLORA INCARNATA, ORNITHOGALUM UMBELLATUM, PHOSPHORICUM ACIDUM, RHAMNUS PURSHIANA, RIBES NIGRUM, SARCOLACTICUM ACIDUM, SEPIA, SOLIDAGO VIRGAUREA, SUS SCROFA PINEAL GLAND, TRYPTOPHAN, TYROSINE, YELLOW JASMINE) SOLUTION/ DROPS [APEX ENERGETICS INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240110_bf77d8e4-cf1c-447f-e053-2995a90a8c6f.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 |
|---|---|---|---|---|---|---|
| E08 BIOCLOCK REGULATOR | BETULA VERRUCOSA, BOS TAURUS ADRENAL GLAND, BOS TAURUS PITUITARUM POSTERIUM, CALCAREA IODATA, COCCULUS INDICUS, COLCHICUM AUTUMNALE, ELEUTHERO, EUROPEAN HORNBEAM FLOWER, EUROPEAN OLIVE, HYPOTHALAMUS, JUNIPERUS COMMUNIS STEM, KALI CARBONICUM, KALI PHOSPHORICUM, LAC CANINUM, NUX VOMICA, PASSIFLORA INCARNATA, ORNITHOGALUM UMBELLATUM, PHOSPHORICUM ACIDUM, RHAMNUS PURSHIANA, RIBES NIGRUM, SARCOLACTICUM ACIDUM, SEPIA, SOLIDAGO VIRGAUREA, SUS SCROFA PINEAL GLAND, TRYPTOPHAN, TYROSINE, YELLOW JASMINE | Apex Energetics Inc. | bf77d8e4-cf1c-447f-e053-2995a90a8c6f | 2024-01-08 | Warnings | 63479-0508-1 63479-0508 63479050801 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63479-0508-1 | 63479050801 | 30 mL in 1 BOTTLE, GLASS (63479-0508-1) | 30 ml | 1988-08-15 | 0000-00-00 | No | No | Current |