CareOne Night TIme Cold and Flu
- Product NDC
- 41520-084
- 11-digit product format
- 415200084
- Labeler code
- 41520
- Product ID
- 41520-084_87dfb140-d122-4b13-8b52-2903d77ce874
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- American Sales Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-04-11
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
- 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
- CareOne Night TIme Cold and Flu
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2 |
| Rxcui | 1043400 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 41520-084-34 | CareOne Night TIme Cold and Flu | 237 mL in 1 BOTTLE | SOLUTION | 237 | | 6 |
| 41520-084-40 | CareOne Night TIme Cold and Flu | 355 mL in 1 BOTTLE | SOLUTION | 355 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 41520-084 | CAREONE NIGHT TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [AMERICAN SALES COMPANY] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241027_d6b9fb27-3ef7-47ee-81f2-b9a3ccd6de25.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 41520-084-34 | 41520008434 | 237 mL in 1 BOTTLE (41520-084-34) | 237 ml | 2016-04-11 | 0000-00-00 | No | No | Current |
| 41520-084-40 | 41520008440 | 355 mL in 1 BOTTLE (41520-084-40) | 355 ml | 2016-04-11 | 0000-00-00 | No | No | Current |