NeoTuss Plus
- Product NDC
- 12539-779
- 11-digit product format
- 125390779
- Labeler code
- 12539
- Product ID
- 12539-779_463c45eb-d68e-f00f-e063-6394a90acc91
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr, Chlorpheniramine Maleate, Phenylephrine HCl
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-03-06
- Substance
- CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 4; 30; 7.5 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NeoTuss Plus
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CHLORPHENIRAMINE MALEATE | 4 mg/5mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/5mL |
| PHENYLEPHRINE HYDROCHLORIDE | 7.5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V1Q0O9OJ9Z, 9D2RTI9KYH, 04JA59TNSJ |
| Rxcui | 2167750 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 12539-779-01 | NeoTuss Plus | 30 mL in 1 BOTTLE | LIQUID | 30 | | 2 |
| 12539-779-16 | NeoTuss Plus | 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 |
|---|
| 12539-779 | NEOTUSS PLUS (DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [DORAL PHARMAMEDICS INC DBA A.G. MARIN PHARMACEUTICALS] | 1 | Current NDC, 1 package rows | 20250322_2fabd782-14dc-1d1b-e063-6394a90af428.zip |
| 12539-779 | NEOTUSS PLUS (DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [DORAL PHARMAMEDICS INC DBA A.G. MARIN PHARMACEUTICALS] | 1 | Current NDC, 1 package rows | 20250303_2f3c6b38-7236-899b-e063-6294a90aabde.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 |
|---|
| 12539-779-01 | 12539077901 | 30 mL in 1 BOTTLE (12539-779-01) | 30 ml | 2025-02-28 | No | No | Current |
| 12539-779-16 | 12539077916 | 474 mL in 1 BOTTLE (12539-779-16) | 474 ml | 2025-03-06 | No | No | Current |