TriStart DHA
- Product NDC
- 15370-250
- 11-digit product format
- 153700250
- Labeler code
- 15370
- Product ID
- 15370-250_4889480e-2d59-4dbd-a808-ea7fce24f922
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE MAGNESIUM, FOLIC ACID, CYANOCOBALAMIN, IRON PENTACARBONYL, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT, and ICOSAPENT
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- CarWin Pharmaceutical Associates, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2015-06-01
- Substance
- .ALPHA.-TOCOPHEROL ACETATE, D-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FOLIC ACID; ICOSAPENT; IRON PENTACARBONYL; LEVOMEFOLATE MAGNESIUM; MAGNESIUM OXIDE; NIACIN; POTASSIUM IODIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE
- Active strength
- 15; 55; 1000; 14; 200; 400; 15; 31; 600; 30; 5; 200; 35; 1.8; 1.3 [iU]/1; mg/1; [iU]/1; ug/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Folate Analog [EPC], Folic Acid [CS], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | 15370-250 | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | 110d247fa046… | a55b01930146… | ||
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 15370-250 | 15370-250-30 | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | 110d247fa046… | a55b01930146… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TriStart DHA
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ASCORBIC ACID | 15 [iU]/1 |
| CHOLECALCIFEROL | 55 mg/1 |
| .ALPHA.-TOCOPHEROL ACETATE, D- | 1000 [iU]/1 |
| THIAMINE HYDROCHLORIDE | 14 ug/1 |
| RIBOFLAVIN | 200 mg/1 |
| NIACIN | 400 ug/1 |
| PYRIDOXINE HYDROCHLORIDE | 15 mg/1 |
| LEVOMEFOLATE MAGNESIUM | 31 mg/1 |
| FOLIC ACID | 600 ug/1 |
| CYANOCOBALAMIN | 30 mg/1 |
| IRON PENTACARBONYL | 5 mg/1 |
| POTASSIUM IODIDE | 200 ug/1 |
| MAGNESIUM OXIDE | 35 mg/1 |
| DOCONEXENT | 1.8 mg/1 |
| ICOSAPENT | 1.3 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| PQ6CK8PD0R | Internal UNII lookup |
| 1C6V77QF41 | Internal UNII lookup |
| A7E6112E4N | Internal UNII lookup |
| M572600E5P | Internal UNII lookup |
| TLM2976OFR | Internal UNII lookup |
| 2679MF687A | Internal UNII lookup |
| 68Y4CF58BV | Internal UNII lookup |
| 1VZZ62R081 | Internal UNII lookup |
| 935E97BOY8 | Internal UNII lookup |
| P6YC3EG204 | Internal UNII lookup |
| 6WQ62TAQ6Z | Internal UNII lookup |
| 1C4QK22F9J | Internal UNII lookup |
| 3A3U0GI71G | Internal UNII lookup |
| ZAD9OKH9JC | Internal UNII lookup |
| AAN7QOV9EA | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 92ccf7d4-4527-49f0-b890-1a11b5a10086 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 15370-250-30 | TriStart DHA | 30 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 30 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 15370-250-30 | EA - Each | 15370-250 | dc53b307-6bde-492d-a5e6-c381c2931a8a | 1 | 2015-07-20 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 15370-250 | TRISTART DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE MAGNESIUM, FOLIC ACID, CYANOCOBALAMIN, IRON PENTACARBONYL, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT, AND ICOSAPENT) CAPSULE, LIQUID FILLED [CARWIN PHARMACEUTICAL ASSOCIATES, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240112_92ccf7d4-4527-49f0-b890-1a11b5a10086.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 |
|---|---|---|---|---|---|---|
| TriStart DHA | ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE MAGNESIUM, FOLIC ACID, CYANOCOBALAMIN, IRON PENTACARBONYL, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT, AND ICOSAPENT | CarWin Pharmaceutical Associates, LLC | 92ccf7d4-4527-49f0-b890-1a11b5a10086 | 2024-01-09 | Boxed warning, Warnings, Adverse reactions | 15370-250 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 15370-250-30 | 15370025030 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (15370-250-30) | 2015-06-01 | 0000-00-00 | No | No | Current |