Sanatos Nighttime Relief
- Product NDC
- 55758-515
- 11-digit product format
- 557580515
- Labeler code
- 55758
- Product ID
- 55758-515_4c26c8bf-0144-ddca-e063-6294a90a3552
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Pharmadel LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-04-01
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 325; 20; 12.5 mg/1; mg/1; mg/1
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sanatos Nighttime Relief
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/1 |
| DOXYLAMINE SUCCINATE | 12.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2 |
| Rxcui | 2739790 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55758-515-08 | Sanatos Nighttime Relief | 8 in 1 CARTON | CAPSULE, LIQUID FILLED | 8 | | 1 |
| 55758-515-08 | Sanatos Nighttime Relief | 2 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 2 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55758-515-08 | 55758051508 | 8 BLISTER PACK in 1 CARTON (55758-515-08) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 8 blister pack | 2026-04-01 | No | No | Historical |