Relax-Tone
- Product NDC
- 64578-0091
- 11-digit product format
- 645780091
- Labeler code
- 64578
- Product ID
- 64578-0091_29049b18-6784-b093-e063-6394a90a2d1c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Calcarea Carbonica, Coffea Cruda, Humulus Lupulus, Ignatia Amara, Kali Phosphoricum, Moschus, Nux Vomica, Passiflora Incarnate, Phosphorus, Pulsatilla Vulgaris, Staphysagria, Valeriana Officinalis
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Energetix Corporation
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2013-10-01
- Substance
- ARABICA COFFEE BEAN; DELPHINIUM STAPHISAGRIA SEED; HOPS; MOSCHUS MOSCHIFERUS MUSK SAC RESIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; POTASSIUM PHOSPHATE, DIBASIC; PULSATILLA VULGARIS; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; VALERIAN
- Active strength
- 12; 12; 10; 12; 12; 4; 12; 12; 12; 12; 12; 4 [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], 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], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], 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
- Relax-Tone
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OYSTER SHELL CALCIUM CARBONATE, CRUDE | 12 [hp_X]/mL |
| ARABICA COFFEE BEAN | 12 [hp_X]/mL |
| HOPS | 10 [hp_X]/mL |
| STRYCHNOS IGNATII SEED | 12 [hp_X]/mL |
| POTASSIUM PHOSPHATE, DIBASIC | 12 [hp_X]/mL |
| MOSCHUS MOSCHIFERUS MUSK SAC RESIN | 4 [hp_X]/mL |
| STRYCHNOS NUX-VOMICA SEED | 12 [hp_X]/mL |
| PASSIFLORA INCARNATA FLOWERING TOP | 12 [hp_X]/mL |
| PHOSPHORUS | 12 [hp_X]/mL |
| PULSATILLA VULGARIS | 12 [hp_X]/mL |
| DELPHINIUM STAPHISAGRIA SEED | 12 [hp_X]/mL |
| VALERIAN | 4 [hp_X]/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2E32821G6I | Internal UNII lookup |
| 3SW678MX72 | Internal UNII lookup |
| 01G73H6H83 | Internal UNII lookup |
| 1NM3M2487K | Internal UNII lookup |
| CI71S98N1Z | Internal UNII lookup |
| 8KFK4W7KP7 | Internal UNII lookup |
| 269XH13919 | Internal UNII lookup |
| CLF5YFS11O | Internal UNII lookup |
| 27YLU75U4W | Internal UNII lookup |
| I76KB35JEV | Internal UNII lookup |
| 00543AP1JV | Internal UNII lookup |
| JWF5YAW3QW | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 85563888-8097-4af4-8ab1-b6d6e545b499 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| efd58dcf-540a-4531-8766-e713129ca6f2 | Product name | 1 | 20250307 |
| 4b7700e3-6e0e-45e5-9d22-6f754d61386e | Product name | 2 | 20250304 |
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64578-0091-1 | Relax-Tone | 59.1 mL in 1 BOTTLE, DROPPER | LIQUID | 59.1 | 12 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64578-0091 | RELAX-TONE (CALCAREA CARBONICA, COFFEA CRUDA, HUMULUS LUPULUS, IGNATIA AMARA, KALI PHOSPHORICUM, MOSCHUS, NUX VOMICA, PASSIFLORA INCARNATE, PHOSPHORUS, PULSATILLA VULGARIS, STAPHYSAGRIA, VALERIANA OFFICINALIS) LIQUID [ENERGETIX CORP] | 11 | Current NDC, Legacy NDC, 1 package rows | 20211222_85563888-8097-4af4-8ab1-b6d6e545b499.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 |
|---|---|---|---|---|---|---|
| Relax-Tone | CALCAREA CARBONICA, COFFEA CRUDA, HUMULUS LUPULUS, IGNATIA AMARA, KALI PHOSPHORICUM, MOSCHUS, NUX VOMICA, PASSIFLORA INCARNATE, PHOSPHORUS, PULSATILLA VULGARIS, STAPHYSAGRIA, VALERIANA OFFICINALIS | Energetix Corporation | 85563888-8097-4af4-8ab1-b6d6e545b499 | 2025-07-11 | Warnings | 64578-0091 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 64578-0091-1 | 64578009101 | 59.1 mL in 1 BOTTLE, DROPPER (64578-0091-1) | 59.1 ml | 2016-12-01 | 0000-00-00 | No | No | Current |