Tri-Vite Drops with Fluoride
- Product NDC
- 58657-323
- 11-digit product format
- 586570323
- Labeler code
- 58657
- Product ID
- 58657-323_41b76910-3e17-3254-e063-6294a90adb54
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A and VITAMIN D
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Method Pharmaceuticals, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2018-07-25
- Substance
- ASCORBIC ACID; SODIUM FLUORIDE; VITAMIN A; VITAMIN D
- Active strength
- 35; .25; 1500; 400 mg/mL; mg/mL; [iU]/mL; [iU]/mL
- Pharmacologic classes
- Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin C [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tri-Vite Drops with Fluoride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ASCORBIC ACID | 35 mg/mL |
| SODIUM FLUORIDE | .25 mg/mL |
| VITAMIN A | 1500 [iU]/mL |
| VITAMIN D | 400 [iU]/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | PQ6CK8PD0R, 8ZYQ1474W7, 81G40H8B0T, 9VU1KI44GP |
| Rxcui | 1365980 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 777d68c6-a5ab-e06c-d314-677b0b9af0c8 | Product name | 2 | 20240508 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58657-323-50 | 2020-02-11 | C162847 | 48780-1 | 9d75b9d0-e70a-f424-e053-dadaa90a57ce | Tri-Vite Drops with Fluroide 0_25 mg |
| 58657-323-50 | 2020-02-11 | C162847 | 48780-1 | 9d75b9d0-e70a-f424-e053-dadaa90a57ce | Tri-Vite Drops with Fluroide 0_25 mg |
| 58657-323-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e70a-f424-e053-dadaa90a57ce | Tri-Vite Drops with Fluroide 0_25 mg |
| 58657-323-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e70a-f424-e053-dadaa90a57ce | Tri-Vite Drops with Fluroide 0_25 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58657-323-50 | Tri-Vite Drops with Fluoride | 50 mL in 1 BOTTLE, DROPPER | SOLUTION | 50 | 7 | |
| 58657-323-50 | Tri-Vite Drops with Fluoride | 1 in 1 CARTON | SOLUTION | 1 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58657-323-50 | ML - Milliliter | 58657-323 | 729a6e64-0967-4b7d-a67d-76e13039de07 | 1 | 2018-09-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58657-323 | TRI-VITE DROPS WITH FLUORIDE (ASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A AND VITAMIN D) SOLUTION [METHOD PHARMACEUTICALS, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241126_003181d4-5412-4ffe-b99d-880f2010e3ad.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1365980 | vitamin C 35 MG/mL / cholecalciferol 0.01 MG/mL / sodium fluoride 0.55 MG/mL / vitamin A palmitate 450 MCG/mL Oral Solution | PSN | 003181d4-5412-4ffe-b99d-880f2010e3ad | 7 |
| 1365980 | ascorbic acid 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 0.55 MG/ML / vitamin A palmitate 1500 UNT/ML Oral Solution | SCD | 003181d4-5412-4ffe-b99d-880f2010e3ad | 7 |
| 1365980 | sodium fluoride 0.55 MG (fluoride ion 0.25 MG) / vitamin A palmitate 450 MCG (1500 UNT) / vitamin C 35 MG / vitamin D3 10 MCG (400 UNT) per ML Oral Solution | SY | 003181d4-5412-4ffe-b99d-880f2010e3ad | 7 |
| 1365980 | vit-C 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 0.55 MG/ML / vitamin A palmitate 1500 UNT/ML Oral Solution | SY | 003181d4-5412-4ffe-b99d-880f2010e3ad | 7 |
| 1365980 | vitamin C 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 0.55 MG/ML / vitamin A palmitate 1500 UNT/ML Oral Solution | SY | 003181d4-5412-4ffe-b99d-880f2010e3ad | 7 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 58657-323-50 | 58657032350 | 1 BOTTLE, DROPPER in 1 CARTON (58657-323-50) / 50 mL in 1 BOTTLE, DROPPER | 2018-07-25 | 0000-00-00 | No | No | Current |