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 |
|---|---|---|---|---|---|---|
| Antiflu Des Cough and Flu | ACETAMINOPHEN PHENYLEPHRINE HCL CHLORPHENIRAMINE MALEATE | Productos Farmaceuticos, S.A. de C.V. | dcf3897a-a793-6df7-e053-2995a90a25f8 | 2024-10-17 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | FSA STORE INC. | ec6aef90-ece1-4fe6-e053-2995a90a9310 | 2024-10-16 | Warnings | M012 |
| Tukol MAX ACTION Cold, Sore Throat and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Genomma Lab USA, Inc | c8eebe64-00bf-436d-a9fc-1623401bebfa | 2024-10-16 | Warnings | M012 |
| Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Discount Drug Mart | 4f42c8d2-0538-4bcd-aac0-e26103a30499 | 2024-10-16 | Warnings | M012 |
| Tukol MAX ACTION Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Genomma Lab USA, Inc | 9ac3e24a-d18a-48fc-8005-55393085d57b | 2024-10-16 | Warnings | M012 |
| Nighttime Cough | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 45471fdd-c4cd-46ad-a932-aa37327e8a41 | 2024-10-16 | Warnings | M012 |
| DG Health Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp Inc | 8cb15a8d-c836-4167-bc6b-dd20a34076e8 | 2024-10-16 | Warnings | M012 |
| basic care nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | f4497e56-c69d-4ae9-bd81-80bf2ee1b17f | 2024-10-15 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | FOODHOLD U.S.A., LLC | 8256c1fb-683d-56ab-e053-2a91aa0ac197 | 2024-10-15 | Warnings | M012 |
| SINUS SEVRE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | 9f9586e3-a8b4-4060-e053-2995a90aa068 | 2024-10-15 | Warnings | M012 |
| ALLERGY RELIEF | DIPHENHYDRAMINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | 9f95715f-63dc-6086-e053-2a95a90adb0c | 2024-10-15 | Warnings | M012 |
| Allergy MultiSymptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | a61636e9-8fe2-8419-e053-2a95a90a011c | 2024-10-15 | Warnings | M012 |
| SINUS AND HEADACHE | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | 9f95b2e8-dea4-ef59-e053-2a95a90a0bcb | 2024-10-15 | Warnings | M012 |
| Cold Multi-Symptom Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | American Sales Company | d2dcbc7c-e66c-4922-83df-c706a37bf334 | 2024-10-15 | Warnings | M012 |
| Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. ( | 9f958d97-8dcf-332d-e053-2995a90a0a65 | 2024-10-15 | Warnings | M012 |
| Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Retail Business Services , LLC. | 8bc68a71-62c5-a04f-e053-2995a90a92fd | 2024-10-15 | Warnings | M012 |
| COLD FLU AND SORE THROAT | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | 9f960566-0158-6637-e053-2995a90a9c4a | 2024-10-15 | Warnings | M012 |
| HEAD CONGESTION PLUS FLU SEVERE PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | e65cf21d-3d69-a53e-e053-2a95a90a1c83 | 2024-10-15 | Warnings | M012 |
| night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | H E B | 49f5f4d3-556c-4ee3-b5cd-5331dd434bb9 | 2024-10-15 | Warnings | M012 |
| Mielim y mas | DEXTROMETHORPHAN | Efficient Laboratories Inc. | 711d1dae-3af4-46af-a3a8-cd827356a81a | 2024-10-14 | 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 |