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 table| Ingredient | Strength |
|---|
| ARABICA COFFEE BEAN | 12 [hp_X]/mL |
| DELPHINIUM STAPHISAGRIA SEED | 12 [hp_X]/mL |
| HOPS | 10 [hp_X]/mL |
| MOSCHUS MOSCHIFERUS MUSK SAC RESIN | 12 [hp_X]/mL |
| OYSTER SHELL CALCIUM CARBONATE, CRUDE | 12 [hp_X]/mL |
| PASSIFLORA INCARNATA FLOWERING TOP | 4 [hp_X]/mL |
| PHOSPHORUS | 12 [hp_X]/mL |
| POTASSIUM PHOSPHATE, DIBASIC | 12 [hp_X]/mL |
| PULSATILLA VULGARIS | 12 [hp_X]/mL |
| STRYCHNOS IGNATII SEED | 12 [hp_X]/mL |
| STRYCHNOS NUX-VOMICA SEED | 12 [hp_X]/mL |
| VALERIAN | 4 [hp_X]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3SW678MX72, 00543AP1JV, 01G73H6H83, 8KFK4W7KP7, 2E32821G6I, CLF5YFS11O, 27YLU75U4W, CI71S98N1Z, I76KB35JEV, 1NM3M2487K, 269XH13919, JWF5YAW3QW |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| 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 |
Packages#
Package NDC, 11-digit format, Description table| 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 |