COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct
- Product NDC
- 76162-678
- 11-digit product format
- 761620678
- Labeler code
- 76162
- Product ID
- 76162-678_f108e17b-8973-49d8-9d1d-5781170f9b4b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Doxylamine Succinate, Phenylephrine Hydrochloride
- Dosage form
- KIT
- Labeler
- Topco Associates LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-12-11
- 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
- COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76162-678-24 | COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct | 1 in 1 CARTON | KIT | 1 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dologesic DF | ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE | Llorens Pharmaceutical International Division | 55768b45-fd98-4779-85b6-6a50c628677e | 2025-12-31 | Warnings | M012 |
| Triponel | DEXTROMETHORPHAN HBR, PSEUFOEPHEDRINE HCL, TRIPROLIDINE HCL | Llorens Pharmaceutical International Division, Inc. | e9a8deb4-0595-4f0f-ac15-f936f15aca88 | 2025-12-31 | Warnings | M012 |
| Tusnel | DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL | Llorens Pharmaceutical International Division | 805dc611-355a-4af5-bf19-464c3290c5c6 | 2025-12-31 | Warnings | M012 |
| Tusnel Pediatric | DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL | Llorens Pharmaceutical International Division | 82f447f6-4f1b-4f56-9d7d-ea02adeea88c | 2025-12-31 | Warnings | M012 |
| Triponel | DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | cc774d33-96ce-4992-ad30-3cb03b0d119d | 2025-12-31 | Warnings | M012 |
| Tusnel SF | DEXTROMETHORPHAN HBR, GUAIFENESIN | Llorens Pharmaceutical International Division, Inc. | cb43b4df-5ccc-416e-abcd-98f079b3f2bb | 2025-12-31 | Warnings | M012 |
| Tusnel Cough Suppressant Expectorant | DEXTROMETHORPHAN HBR, GUAIFENESIN | Llorens Pharmaceutical International Division, Inc. | af71cdbc-33d6-4303-b494-d7321721d3be | 2025-12-31 | Warnings | M012 |
| Tusnel Pediatric DM | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Llorens Pharmaceutical International Division, Inc. | 63541753-de8d-42fe-a9b3-a5eac3fcdca4 | 2025-12-31 | Warnings | M012 |
| Tusnel Pediatric Drops | GUAIFENESIN, PHENYLEPHRINE HCL | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | dbf7c43a-7b29-4c70-9e6d-8a7ea924a9d7 | 2025-12-31 | Warnings | M012 |
| Tusnel DM Pediatric | DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL | Llorens Pharmaceutical International Division | d915eab8-013e-4ce3-b358-0d531e5ca1ba | 2025-12-31 | Warnings | M012 |
| Tusnel-DM Pediatric | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 64e36b02-b5be-4d20-8818-cb5b23596671 | 2025-12-31 | Warnings | M012 |
| Honey Lemon Cough Drops | MENTHOL | Bestco Inc. | 77f89a64-f4a4-f909-e053-2a91aa0ad44d | 2025-12-31 | Warnings | M012 |
| Honey Lemon Cough Drops | MENTHOL | Bestco Inc. | 77f65f59-7ea1-adce-e053-2991aa0a6f1f | 2025-12-31 | Warnings | M012 |
| Sugar Free Honey Lemon Cough Drops | MENTHOL | Bestco Inc. | 77f9e176-d87a-beed-e053-2991aa0aac20 | 2025-12-31 | Warnings | M012 |
| Sugar Free Cherry Cough Drops | MENTHOL | Bestco Inc. | 7858f380-bef7-3d30-e053-2a91aa0a7ea6 | 2025-12-31 | Warnings | M012 |
| Strawberry Cough Drops | MENTHOL | BestCo Inc. | 26a22cfd-395b-4ffb-e054-00144ff88e88 | 2025-12-31 | Warnings | M012 |
| Limpia Pecho | DEXTROMETHORPHAN HBR, GUAIFENESIN | Llorens Pharmaceutical International Division, Inc. | cbaea3e4-4c4b-4ff9-ae6f-95b6a2d3faf3 | 2025-12-31 | Warnings | M012 |
| Cherry Sore Throat Lozenges | BENZOCAINE | Bestco Inc. | 737efd41-2d59-6013-e053-2a91aa0a6c63 | 2025-12-31 | Warnings | M012 |
| Best Health Menthol Cough Drops | MENTHOL | Bestco LLC | dda66a3c-9006-ff1a-e053-2a95a90abfb3 | 2025-12-31 | Warnings | M012 |
| Rynex DM | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Edwards Pharmaceuticals, Inc | 7be2c282-24ba-4f19-9b14-872d3f5746a7 | 2025-12-31 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2634364 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } Pack | GPCK | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2 |
| 2634364 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) Pack | PSN | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2 |
| 1297288 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2 |
| 1656815 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2 |
| 1297288 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2 |
| 1656815 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2 |
| 2634364 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) Pack | SY | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2 |
| 1297288 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2 |
| 1656815 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 76162-678-24 | 76162067824 | 1 KIT in 1 CARTON (76162-678-24) * 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 kit | 2025-12-11 | No | No | Current |