Melatonin Forte
- Product NDC
- 43857-0020
- 11-digit product format
- 438570020
- Labeler code
- 43857
- Product ID
- 43857-0020_e4870daa-d5eb-4d5f-a0c9-5b99ce05114e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Melatonin, Nadidum, Niacin, Pyridoxinum Hydrochloricum, Zincum Sulphuricum, Hypophysis Suis, Hypothalamus (Suis), Lithium Carbonicum, Magnesia Carbonica, Pineal (Suis)
- Dosage form
- SPRAY
- Route
- ORAL
- Labeler
- BioActive Nutritional, Inc.
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2012-05-04
- Substance
- LITHIUM CARBONATE; MAGNESIUM CARBONATE; MELATONIN; NADIDE; NIACIN; PYRIDOXINE HYDROCHLORIDE; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PINEAL GLAND; SUS SCROFA PITUITARY GLAND; ZINC SULFATE HEPTAHYDRATE
- Active strength
- 8; 8; 6; 6; 6; 6; 8; 8; 8; 6 [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
- Analogs/Derivatives [Chemical/Ingredient], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Mood Stabilizer [EPC], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Melatonin Forte
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LITHIUM CARBONATE | 8 [hp_X]/mL |
| MAGNESIUM CARBONATE | 8 [hp_X]/mL |
| MELATONIN | 6 [hp_X]/mL |
| NADIDE | 6 [hp_X]/mL |
| NIACIN | 6 [hp_X]/mL |
| PYRIDOXINE HYDROCHLORIDE | 6 [hp_X]/mL |
| SUS SCROFA HYPOTHALAMUS | 8 [hp_X]/mL |
| SUS SCROFA PINEAL GLAND | 8 [hp_X]/mL |
| SUS SCROFA PITUITARY GLAND | 8 [hp_X]/mL |
| ZINC SULFATE HEPTAHYDRATE | 6 [hp_X]/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 2BMD2GNA4V, 0E53J927NA, JL5DK93RCL, 0U46U6E8UK, 2679MF687A, 68Y4CF58BV, N6R0856Z79, 050QZ2EDK7, L0PFEMQ1DT, N57JI2K7WP |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| b3053bb1-353b-4a0b-bca5-28fe7228957c | Product name | 2 | 20250124 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| e2dae634-14ed-febf-08ee-93196433b5b7 | Product name | 9 | 20190614 |
| 8ce6e144-236f-b7be-f690-f06e0c8c6bd3 | Product name | 2 | 20170725 |
| f09af6ee-c6dd-d0ce-77ad-93508bcdaced | Product name | 4 | 20161205 |
| 5e18e798-5614-cf5c-0185-38b1cb77a093 | Product name | 2 | 20160822 |
| 0a5e5249-329b-0cff-e714-77159f193a87 | Product name | 1 | 20140508 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
| 6b7a6f32-42a6-994d-5ab6-d180e92ee9d8 | Product name | 1 | 20140508 |
| d394f843-7479-dc48-dbd3-232266c5548c | Product name | 1 | 20140508 |
| dc9a5fb6-14e2-1cc8-a567-a781fd1f0212 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43857-0020-1 | 2023-08-18 | C162847 | 48780-1 | f386c64a-0856-0266-e053-dadaa90a7c1a | DRUG FACTS: |
| 43857-0020-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0856-0266-e053-dadaa90a7c1a | DRUG FACTS: |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43857-0020-1 | Melatonin Forte | 30 mL in 1 BOTTLE, SPRAY | SPRAY | 30 | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43857-0020 | MELATONIN FORTE (MELATONIN, NADIDUM, NIACIN, PYRIDOXINUM HYDROCHLORICUM, ZINCUM SULPHURICUM, HYPOPHYSIS SUIS, HYPOTHALAMUS (SUIS), LITHIUM CARBONICUM, MAGNESIA CARBONICA, PINEAL (SUIS)) SPRAY [BIOACTIVE NUTRITIONAL, INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20250516_410861ef-3f55-4a09-888e-2123b820f878.zip |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43857-0020-1 | 43857002001 | 30 mL in 1 BOTTLE, SPRAY (43857-0020-1) | 30 ml | 2017-01-12 | 0000-00-00 | No | No | Current |