Relaxatone
- Product NDC
- 44911-0640
- 11-digit product format
- 449110640
- Labeler code
- 44911
- Product ID
- 44911-0640_ffdad01b-2ad0-45af-a545-76d40fd266f9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Passiflora Incarnata, Scutellaria Lateriflora, Valeriana Officinalis, Arsenicum Album, Calcarea Carbonica, Coffea Cruda
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Energique, Inc.
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2021-06-22
- Substance
- ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; DELPHINIUM STAPHISAGRIA SEED; LYCOPUS VIRGINICUS WHOLE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM PHOSPHATE, DIBASIC; SCUTELLARIA LATERIFLORA WHOLE; STRYCHNOS IGNATII SEED; VALERIAN
- Active strength
- 12; 12; 12; 12; 12; 3; 12; 3; 12; 3 [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], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant 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
- Relaxatone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ARABICA COFFEE BEAN | 12 [hp_X]/mL |
| ARSENIC TRIOXIDE | 12 [hp_X]/mL |
| DELPHINIUM STAPHISAGRIA SEED | 12 [hp_X]/mL |
| LYCOPUS VIRGINICUS WHOLE | 12 [hp_X]/mL |
| OYSTER SHELL CALCIUM CARBONATE, CRUDE | 12 [hp_X]/mL |
| PASSIFLORA INCARNATA FLOWERING TOP | 3 [hp_X]/mL |
| POTASSIUM PHOSPHATE, DIBASIC | 12 [hp_X]/mL |
| SCUTELLARIA LATERIFLORA WHOLE | 3 [hp_X]/mL |
| STRYCHNOS IGNATII SEED | 12 [hp_X]/mL |
| VALERIAN | 3 [hp_X]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3SW678MX72, S7V92P67HO, 00543AP1JV, TWH5125Q6F, 2E32821G6I, CLF5YFS11O, CI71S98N1Z, 7BP4DH5PDC, 1NM3M2487K, JWF5YAW3QW |
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 |
|---|
| 44911-0640-1 | Relaxatone | 60 mL in 1 BOTTLE, DROPPER | LIQUID | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 44911-0640 | RELAXATONE (PASSIFLORA INCARNATA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALIS, ARSENICUM ALBUM, CALCAREA CARBONICA, COFFEA CRUDA) LIQUID [ENERGIQUE, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240713_98fd169f-84b7-415e-a7e8-bbb7d7f81ac4.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 44911-0640-1 | 44911064001 | 60 mL in 1 BOTTLE, DROPPER (44911-0640-1) | 60 ml | 2021-06-22 | 0000-00-00 | No | No | Current |