Sanatos
- Product NDC
- 55758-415
- 11-digit product format
- 557580415
- Labeler code
- 55758
- Product ID
- 55758-415_0a5fc0ef-ba33-bb0b-e063-6394a90af7d9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Pharmadel LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-12-01
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 650; 20 mg/30mL; mg/30mL
- Pharmacologic classes
- 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
- Sanatos
- Brand name suffix
- Multi Symptom Daytime
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/30mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH |
| Rxcui | 2604561 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55758-415-06 | SanatosMulti Symptom Daytime | 177 mL in 1 BOTTLE, PLASTIC | LIQUID | 177 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55758-415 | SANATOS MULTI SYMPTOM DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR) LIQUID [PHARMADEL LLC] | 1 | Current NDC, 1 package rows | 20231201_0a5fc0ef-ba34-bb0b-e063-6394a90af7d9.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 |
|---|
| 55758-415-06 | 55758041506 | 177 mL in 1 BOTTLE, PLASTIC (55758-415-06) | 177 ml | 2023-12-01 | No | No | Current |