SAFETUSSIN Non Drowsy
- Product NDC
- 55505-220
- 11-digit product format
- 555050220
- Labeler code
- 55505
- Product ID
- 55505-220_cff65bfa-6667-4ecf-a98c-a93b50d2d161
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan Hydrobromide, and Guaifenesin
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- KRAMER LABORATORIES
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-06-01
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 10; 100 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
- SAFETUSSIN Non Drowsy
- Brand name suffix
- Cough plus chest congestion
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/5mL |
| GUAIFENESIN | 100 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, 495W7451VQ |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55505-220-33 | SAFETUSSIN Non DrowsyCough plus chest congestion | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 | | 5 |
| 55505-220-36 | SAFETUSSIN Non DrowsyCough plus chest congestion | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55505-220 | SAFETUSSIN NON DROWSY COUGH PLUS CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN) LIQUID [KRAMER LABORATORIES] | 4 | Current NDC, 2 package rows | 20241208_60311ca3-8544-417e-aa29-e9f65c6692ba.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55505-220-33 | 55505022033 | 118 mL in 1 BOTTLE, PLASTIC (55505-220-33) | 118 ml | 2025-07-01 | No | No | Historical |
| 55505-220-36 | 55505022036 | 237 mL in 1 BOTTLE, PLASTIC (55505-220-36) | 237 ml | 2023-06-01 | No | No | Historical |