Quflora Pediatric
- Product NDC
- 15370-105
- 11-digit product format
- 153700105
- Labeler code
- 15370
- Product ID
- 15370-105_0ad40f28-c81d-440a-8c07-d59f667487ed
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- CarWin Pharmaceutical Associates, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2014-01-06
- Substance
- .ALPHA.-TOCOPHEROL, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CUPRIC SULFATE; CYANOCOBALAMIN; FOLIC ACID; LEVOMEFOLIC ACID; MAGNESIUM OXIDE; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM FLUORIDE; THIAMINE HYDROCHLORIDE; VITAMIN A ACETATE
- Active strength
- 15; 60; 400; 1; 4; 100; 108; 15; 5; 1.5; 1.3; 1; 1.2; 1200 [iU]/1; mg/1; [iU]/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/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], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], 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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 15370-105-30 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 15370-105-30 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 15370-105-30 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 15370-105-30 | 8dfbde2a14a4… | c9ff85d89658… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Quflora Pediatric
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| VITAMIN A ACETATE | 15 [iU]/1 |
| ASCORBIC ACID | 60 mg/1 |
| CHOLECALCIFEROL | 400 [iU]/1 |
| .ALPHA.-TOCOPHEROL, DL- | 1 mg/1 |
| THIAMINE HYDROCHLORIDE | 4 ug/1 |
| RIBOFLAVIN | 100 ug/1 |
| NIACINAMIDE | 108 ug/1 |
| PYRIDOXINE HYDROCHLORIDE | 15 mg/1 |
| LEVOMEFOLIC ACID | 5 mg/1 |
| FOLIC ACID | 1.5 mg/1 |
| CYANOCOBALAMIN | 1.3 mg/1 |
| MAGNESIUM OXIDE | 1 mg/1 |
| CUPRIC SULFATE | 1.2 mg/1 |
| SODIUM FLUORIDE | 1200 [iU]/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 68Y4CF58BV | Internal UNII lookup |
| 25X51I8RD4 | Internal UNII lookup |
| 8ZYQ1474W7 | Internal UNII lookup |
| M572600E5P | Internal UNII lookup |
| 3LE3D9D6OY | Internal UNII lookup |
| 935E97BOY8 | Internal UNII lookup |
| P6YC3EG204 | Internal UNII lookup |
| 1C6V77QF41 | Internal UNII lookup |
| 8S95DH25XC | Internal UNII lookup |
| LRX7AJ16DT | Internal UNII lookup |
| 3A3U0GI71G | Internal UNII lookup |
| TLM2976OFR | Internal UNII lookup |
| PQ6CK8PD0R | Internal UNII lookup |
| 7QWA1RIO01 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b8e08798-d8bb-4616-996b-a2c07a5d730a | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 15370-105-30 | 2024-01-11 | C162847 | 48780-1 | ba0f9c33-55e8-a910-e053-dadaa90a0b85 | Quflora™ Pediatric Chewable Tablets |
| 15370-105-30 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-55e8-a910-e053-dadaa90a0b85 | Quflora™ Pediatric Chewable Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 15370-105-30 | Quflora Pediatric | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 15370-105-30 | EA - Each | 15370-105 | 7751f97d-5058-4c7e-9bec-a1c6a40549dc | 1 | 2014-02-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 15370-105 | QUFLORA PEDIATRIC (VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, AND SODIUM FLUORIDE) TABLET, CHEWABLE [CARWIN PHARMACEUTICAL ASSOCIATES, LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240112_b8e08798-d8bb-4616-996b-a2c07a5d730a.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 |
|---|---|---|---|---|---|---|
| Quflora Pediatric | VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, AND SODIUM FLUORIDE | CarWin Pharmaceutical Associates, LLC | b8e08798-d8bb-4616-996b-a2c07a5d730a | 2024-01-10 | Warnings, Adverse reactions | 15370-105 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 15370-105-30 | 15370010530 | 30 TABLET, CHEWABLE in 1 BOTTLE (15370-105-30) | 2014-01-06 | No | No | Current |