Topcare NiteTime Cold and Flu Relief
- Product NDC
- 76162-599
- 11-digit product format
- 761620599
- Labeler code
- 76162
- Product ID
- 76162-599_d6082589-fb18-4ad4-8a38-0a62e4025ba2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-07-15
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 325; 10; 6.25 mg/15mL; mg/15mL; mg/15mL
- 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
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Topcare NiteTime Cold and Flu Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/15mL |
| DOXYLAMINE SUCCINATE | 6.25 mg/15mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1042675 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b2b3c450-e988-41d1-9e53-cc8e30d75cb4 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76162-599-40 | Topcare NiteTime Cold and Flu Relief | 355 mL in 1 BOTTLE | SOLUTION | 355 | 3 | |
| 76162-599-40 | Topcare DayTime NiteTime Cold and Flu Relief | 355 mL in 1 BOTTLE | SOLUTION | 355 mL | 10 mg in 15mL | 2 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1042675 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG in 15 mL Oral Solution | PSN | b2b3c450-e988-41d1-9e53-cc8e30d75cb4 | 3 |
| 1042675 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | b2b3c450-e988-41d1-9e53-cc8e30d75cb4 | 3 |
| 1042675 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | b2b3c450-e988-41d1-9e53-cc8e30d75cb4 | 3 |
| 1042675 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | b2b3c450-e988-41d1-9e53-cc8e30d75cb4 | 3 |
| 1042675 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | b2b3c450-e988-41d1-9e53-cc8e30d75cb4 | 3 |
| 2687211 | {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution) } Pack | GPCK | 560fb22b-391f-4d7b-a6fd-38d577d404b0 | 2 |
| 2687211 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG in 15 mL Oral Solution) Pack | PSN | 560fb22b-391f-4d7b-a6fd-38d577d404b0 | 2 |
| 1042675 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG in 15 mL Oral Solution | PSN | 560fb22b-391f-4d7b-a6fd-38d577d404b0 | 2 |
| 2604561 | acetaminophen 650 MG / dextromethorphan HBr 20 MG in 30 mL Oral Solution | PSN | 560fb22b-391f-4d7b-a6fd-38d577d404b0 | 2 |
| 1042675 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 560fb22b-391f-4d7b-a6fd-38d577d404b0 | 2 |
| 2604561 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution | SCD | 560fb22b-391f-4d7b-a6fd-38d577d404b0 | 2 |
| 2687211 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG per 15 mL Oral Solution) Pack | SY | 560fb22b-391f-4d7b-a6fd-38d577d404b0 | 2 |
| 1042675 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 560fb22b-391f-4d7b-a6fd-38d577d404b0 | 2 |
| 2604561 | acetaminophen 325 MG / dextromethorphan HBr 10 MG per 15 ML Oral Solution | SY | 560fb22b-391f-4d7b-a6fd-38d577d404b0 | 2 |
| 1042675 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 560fb22b-391f-4d7b-a6fd-38d577d404b0 | 2 |
| 2604561 | acetaminophen 650 MG / dextromethorphan HBr 20 MG per 30 ML Oral Solution | SY | 560fb22b-391f-4d7b-a6fd-38d577d404b0 | 2 |
| 1042675 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 560fb22b-391f-4d7b-a6fd-38d577d404b0 | 2 |
| 2604561 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution | SY | 560fb22b-391f-4d7b-a6fd-38d577d404b0 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 76162-599-40 | 76162059940 | 355 mL in 1 BOTTLE (76162-599-40) | 355 ml | 2025-07-15 | No | No | Current |