Daytime Cold and Cough Nighttime Cold and Congestion
- Product NDC
- 51316-939
- 11-digit product format
- 513160939
- Labeler code
- 51316
- Product ID
- 51316-939_1d9b6133-6f2e-4e5c-8c5a-01846d64dbbd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Brompheniramine Maleate, Dextromethorphan HBr, Diphenhydramine HCl, Phenylephrine HCl
- Dosage form
- KIT
- Labeler
- CVS
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-01-31
- Marketing end
- 2027-01-31
- NDC exclude flag
- No
- 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
- Daytime Cold and Cough Nighttime Cold and Congestion
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2cf361eb-6055-2364-e063-6294a90a69a1 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-916-03 | Daytime Cold and Cough Nighttime Cold and Congestion | 118 mL in 1 BOTTLE | LIQUID | 118 mL | 1 mg in 5mL | 3 |
| 51316-916-03 | Daytime Cold and Cough Nighttime Cold and Congestion | 1 in 1 CARTON | LIQUID | 5 mg in 5mL | 3 | |
| 51316-919-03 | Daytime Cold and Cough Nighttime Cold and Congestion | 118 mL in 1 BOTTLE | LIQUID | 118 mL | 6.25 mg in 5mL | 3 |
| 51316-919-03 | Daytime Cold and Cough Nighttime Cold and Congestion | 1 in 1 CARTON | LIQUID | 6.25 mg in 5mL | 3 | |
| 51316-939-04 | Daytime Cold and Cough Nighttime Cold and Congestion | 1 in 1 KIT | KIT | 1 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51316-939 | DAYTIME COLD AND COUGH NIGHTTIME COLD AND CONGESTION (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [CVS] | 2 | Current NDC, 5 package rows | 20250206_2cf361eb-6055-2364-e063-6294a90a69a1.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.
| 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 |
|---|---|---|---|---|
| 1666116 | {1 (brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } Pack | GPCK | 2cf361eb-6055-2364-e063-6294a90a69a1 | 3 |
| 1666116 | 1 daytime (brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) Pack | PSN | 2cf361eb-6055-2364-e063-6294a90a69a1 | 3 |
| 1090463 | brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | 2cf361eb-6055-2364-e063-6294a90a69a1 | 3 |
| 1236048 | diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | 2cf361eb-6055-2364-e063-6294a90a69a1 | 3 |
| 1090463 | brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 2cf361eb-6055-2364-e063-6294a90a69a1 | 3 |
| 1236048 | diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 2cf361eb-6055-2364-e063-6294a90a69a1 | 3 |
| 1666116 | 1 daytime (brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) Pack | SY | 2cf361eb-6055-2364-e063-6294a90a69a1 | 3 |
| 1666116 | 1 daytime (brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) Pack | SY | 2cf361eb-6055-2364-e063-6294a90a69a1 | 3 |
| 1090463 | brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution | SY | 2cf361eb-6055-2364-e063-6294a90a69a1 | 3 |
| 1090463 | brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | 2cf361eb-6055-2364-e063-6294a90a69a1 | 3 |
| 1236048 | diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | 2cf361eb-6055-2364-e063-6294a90a69a1 | 3 |
| 1236048 | diphenhydramine HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution | SY | 2cf361eb-6055-2364-e063-6294a90a69a1 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51316-916-03 | 51316091603 | 118 mL in 1 BOTTLE | 118 ml | Historical | ||||
| 51316-919-03 | 51316091903 | 118 mL in 1 BOTTLE | 118 ml | Historical | ||||
| 51316-939-04 | 51316093904 | 1 KIT in 1 KIT (51316-939-04) * 1 BOTTLE in 1 CARTON (51316-916-03) / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (51316-919-03) / 118 mL in 1 BOTTLE | 1 kit | 2025-01-31 | 2027-01-31 | No | No | Historical |