SAFETUSSIN MAX STRENGTH MS
- Product NDC
- 55505-230
- 11-digit product format
- 555050230
- Labeler code
- 55505
- Product ID
- 55505-230_3dbd264d-5108-4b29-8881-728cea879dd7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, and Guaifenesin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- KRAMER LABORATORIES
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-05-17
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 325; 10; 200 mg/1; mg/1; mg/1
- 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 MAX STRENGTH MS
- Brand name suffix
- Cough, Cold and Flu
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| GUAIFENESIN | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ |
| Rxcui | 2684921 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55505-230-24 | SAFETUSSIN MAX STRENGTH MSCough, Cold and Flu | 24 in 1 CARTON | TABLET | 24 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55505-230 | SAFETUSSIN MAX STRENGTH MS COUGH, COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN) TABLET [KRAMER LABORATORIES] | 1 | Current NDC, 1 package rows | 20240612_920bde5f-4079-45de-aa59-24b00e50cb56.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 |
|---|
| 55505-230-24 | 55505023024 | 24 TABLET in 1 CARTON (55505-230-24) | 24 tablet | 2024-05-17 | No | No | Historical |