NeoTuss S/F
- Product NDC
- 12539-555
- 11-digit product format
- 125390555
- Labeler code
- 12539
- Product ID
- 12539-555_463c3e8f-7445-efdd-e063-6394a90a660b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin, Dextromethorphan HBr
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-02-28
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 30; 200 mg/5mL; mg/5mL
- Pharmacologic classes
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NeoTuss S/F
- Brand name suffix
- Grape-Menthol Flavor
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/5mL |
| GUAIFENESIN | 200 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, 495W7451VQ |
| Rxcui | 1147924 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 12539-555-01 | NeoTuss S/FGrape-Menthol Flavor | 30 mL in 1 BOTTLE | LIQUID | 30 | | 2 |
| 12539-555-16 | NeoTuss S/FGrape-Menthol Flavor | 474 mL in 1 BOTTLE | LIQUID | 474 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 12539-555 | NEOTUSS S/F GRAPE-MENTHOL FLAVOR (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [DORAL PHARMAMEDICS INC DBA A.G. MARIN PHARMACEUTICALS] | 1 | Current NDC, 1 package rows | 20250322_2fac3425-32f0-38d6-e063-6394a90a6e7a.zip |
| 12539-555 | NEOTUSS S/F GRAPE-MENTHOL FLAVOR (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [DORAL PHARMAMEDICS INC DBA A.G. MARIN PHARMACEUTICALS] | 1 | Current NDC, 1 package rows | 20250303_2f3df82c-1926-5238-e063-6294a90a7bbf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 12539-555-01 | 12539055501 | 30 mL in 1 BOTTLE (12539-555-01) | 30 ml | 2025-02-28 | No | No | Current |
| 12539-555-16 | 12539055516 | 474 mL in 1 BOTTLE (12539-555-16) | 474 ml | 2025-03-06 | No | No | Current |