TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT
- Product NDC
- 50580-131
- 11-digit product format
- 505800131
- Labeler code
- 50580
- Product ID
- 50580-131_572ebe9a-09d7-46c2-e063-6394a90a26b5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-09-25
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN
- Active strength
- 15; 6.25; 325 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
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
- TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/1 |
| DOXYLAMINE SUCCINATE | 6.25 mg/1 |
| ACETAMINOPHEN | 325 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1094549 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1c5386c1-e45d-9dcb-e063-6294a90aff07 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-131-24 | TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 3 | |
| 50580-131-24 | TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50580-131 | TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [KENVUE BRANDS LLC] | 3 | Current NDC, 2 package rows | 20241215_1c5386c1-e45d-9dcb-e063-6294a90aff07.zip |
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 |
|---|---|---|---|---|
| 2676954 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } Pack | GPCK | 1c5578e6-7e67-c467-e063-6294a90a6e0b | 3 |
| 2676954 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | PSN | 1c5578e6-7e67-c467-e063-6294a90a6e0b | 3 |
| 1867684 | acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule | PSN | 1c5578e6-7e67-c467-e063-6294a90a6e0b | 3 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 1c5386c1-e45d-9dcb-e063-6294a90aff07 | 3 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 1c5578e6-7e67-c467-e063-6294a90a6e0b | 3 |
| 1867684 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Capsule | SCD | 1c5578e6-7e67-c467-e063-6294a90a6e0b | 3 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 1c5578e6-7e67-c467-e063-6294a90a6e0b | 3 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 1c5386c1-e45d-9dcb-e063-6294a90aff07 | 3 |
| 2676954 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | SY | 1c5578e6-7e67-c467-e063-6294a90a6e0b | 3 |
| 1867684 | acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule | SY | 1c5578e6-7e67-c467-e063-6294a90a6e0b | 3 |
| 1867684 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG Oral Capsule | SY | 1c5578e6-7e67-c467-e063-6294a90a6e0b | 3 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 1c5578e6-7e67-c467-e063-6294a90a6e0b | 3 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 1c5386c1-e45d-9dcb-e063-6294a90aff07 | 3 |
| 2676954 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } Pack | GPCK | 48f7933e-6582-638c-e063-6394a90abfe5 | 1 |
| 2676954 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | PSN | 48f7933e-6582-638c-e063-6394a90abfe5 | 1 |
| 1867684 | acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule | PSN | 48f7933e-6582-638c-e063-6394a90abfe5 | 1 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 48f7933e-6582-638c-e063-6394a90abfe5 | 1 |
| 1867684 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Capsule | SCD | 48f7933e-6582-638c-e063-6394a90abfe5 | 1 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 48f7933e-6582-638c-e063-6394a90abfe5 | 1 |
| 2676954 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | SY | 48f7933e-6582-638c-e063-6394a90abfe5 | 1 |
| 1867684 | acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule | SY | 48f7933e-6582-638c-e063-6394a90abfe5 | 1 |
| 1867684 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG Oral Capsule | SY | 48f7933e-6582-638c-e063-6394a90abfe5 | 1 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 48f7933e-6582-638c-e063-6394a90abfe5 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50580-131-24 | 50580013124 | 2 BLISTER PACK in 1 CARTON (50580-131-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2 blister pack | 2024-09-25 | No | No | Current |