topcare nite time cold and flu relief
- Product NDC
- 36800-335
- 11-digit product format
- 368000335
- Labeler code
- 36800
- Product ID
- 36800-335_cb441ae0-196f-44d9-87b0-2f35facdd717
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-08-18
- 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
- topcare nite time cold and flu relief
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2 |
| Rxcui | 1043400 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-335-30 | topcare nite time cold and flu relief | 177 mL in 1 BOTTLE | SOLUTION | 177 | 12 | |
| 36800-335-34 | topcare nite time cold and flu relief | 237 mL in 1 BOTTLE | SOLUTION | 237 | 12 | |
| 36800-335-38 | topcare nite time cold and flu relief | 296 mL in 1 BOTTLE | SOLUTION | 296 | 12 | |
| 36800-335-40 | topcare nite time cold and flu relief | 355 mL in 1 BOTTLE | SOLUTION | 355 | 12 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 36800-335 | TOPCARE NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TOPCO ASSOCIATES LLC] | 11 | Current NDC, Legacy NDC, 4 package rows | 20241025_31210a95-f9dc-49db-aab5-25c4dca49266.zip |
| 36800-335 | TOPCARE DAY TIME NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [TOPCO ASSOCIATES LLC] | 8 | Current NDC, Legacy NDC | 20241116_6cdc10f7-fd6e-4ea3-a466-97cb59b813f5.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 31210a95-f9dc-49db-aab5-25c4dca49266 | 12 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 31210a95-f9dc-49db-aab5-25c4dca49266 | 12 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 31210a95-f9dc-49db-aab5-25c4dca49266 | 12 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 31210a95-f9dc-49db-aab5-25c4dca49266 | 12 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 31210a95-f9dc-49db-aab5-25c4dca49266 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 36800-335-30 | 36800033530 | 177 mL in 1 BOTTLE | 177 ml | Historical | ||||
| 36800-335-34 | 36800033534 | 237 mL in 1 BOTTLE (36800-335-34) | 237 ml | 2012-07-17 | 0000-00-00 | No | No | Current |
| 36800-335-38 | 36800033538 | 296 mL in 1 BOTTLE | 296 ml | Historical | ||||
| 36800-335-40 | 36800033540 | 355 mL in 1 BOTTLE (36800-335-40) | 355 ml | 2012-07-16 | 0000-00-00 | No | No | Current |