Severe Nighttime Severe Daytime
- Product NDC
- 59779-597
- 11-digit product format
- 597790597
- Labeler code
- 59779
- Product ID
- 59779-597_479ff3f6-5444-4bb2-9c8f-e66ea39dde51
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
- Dosage form
- KIT
- Labeler
- CVS Pharmacy
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-12-27
- 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
- Severe Nighttime Severe Daytime
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1ec3fc79-4f38-439f-99be-646b82231aa5 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59779-597-02 | Severe Nighttime Severe Daytime | 1 in 1 CARTON | KIT | 1 | 6 | |
| 59779-603-40 | Severe Nighttime Severe Daytime | 355 mL in 1 BOTTLE | SOLUTION | 355 mL | 200 mg in 15mL | 6 |
| 59779-763-40 | Severe Nighttime Severe Daytime | 355 mL in 1 BOTTLE | SOLUTION | 355 mL | 650 mg in 30mL | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59779-597 | SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] | 5 | Current NDC, Legacy NDC, 3 package rows | 20250117_1ec3fc79-4f38-439f-99be-646b82231aa5.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 |
|---|---|---|---|---|---|---|
| Kroger DayTime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | The Kroger Co. | 2499210b-c162-76b9-e063-6294a90adbc3 | 2025-01-17 | Warnings | M012 |
| Childrens Multi Symptom Cold Very Berry | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS | 2a849ae9-338f-4642-e063-6394a90a1ca4 | 2025-01-17 | Warnings | M012 |
| Kroger NightTime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | The Kroger Co. | 24a73de3-e9eb-4cd4-e063-6394a90aa263 | 2025-01-17 | Warnings | M012 |
| Diphenhydramine HCl Oral Solution | DIPHENHYDRAMINE HCL ORAL | Everpharm LLC | d7aaf874-69ac-49cf-93be-6d4a38b9a557 | 2025-01-16 | Warnings | M012 |
| Cough Relief | DEXTROMETHORPHAN HBR | Best Choice (Valu Merchandisers Company) | 204a7fc4-142d-45fd-8a77-0612857132be | 2025-01-16 | Warnings | M012 |
| daytime cold and flu nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | df31056b-d0eb-4094-98d9-3d444210d50d | 2025-01-16 | Warnings | M012 |
| Childrens Ibuprofen Oral Suspension | IBUPROFEN | Reliable 1 Laboratories LLC | 28dd9baa-43bd-b60a-e063-6394a90a8cf7 | 2025-01-15 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | Reliable 1 Laboratories LLC | ae469d4f-91c4-cff0-e053-2995a90a0497 | 2025-01-15 | Warnings | M012 |
| Diphenhydramine HCL 25 mg | DIPHENHYDRAMINE HCL | Reliable 1 Laboratories LLC | 32f58cb3-941f-263b-e054-00144ff8d46c | 2025-01-15 | Warnings | M012 |
| Diphenhydramine HCl 25 mg | DIPHENHYDRAMINE HCL | Reliable 1 Laboratories LLC | 32fa40ad-fed5-586f-e054-00144ff88e88 | 2025-01-15 | Warnings | M012 |
| CVS Health Chest Congestion and Cough HBP SOFTGEL | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS Pharmacy, Inc | 2741ba44-1cc7-1812-e063-6394a90a8faa | 2025-01-14 | Warnings | M012 |
| DAY COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TARGET CORPORATION | 2b941963-8a8c-4148-e063-6294a90a1dfb | 2025-01-13 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | SDA Laboratories, Inc. | 437e6a13-a4ff-4f98-8973-042f224ee85e | 2025-01-13 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | SDA Laboratories, Inc. | 6a520986-1004-4ee6-9a47-1dfd90bb1b2c | 2025-01-13 | Warnings | M012 |
| good sense daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L. Perrigo Company | 5ddf3283-94e4-465d-842a-471ee946c330 | 2025-01-10 | Warnings | M012 |
| Vicks VapoSteam | CAMPHOR (SYNTHETIC) | Kaz USA, Inc | c28da455-07ad-4053-8b9e-fc559f9a3f72 | 2025-01-10 | Warnings | M012 |
| Guaifenesin 200mg | GUAIFENESIN | Aphena Pharma Solutions - Tennessee, LLC | 45ac210a-8c54-4469-8e10-e6fe52b89cb5 | 2025-01-09 | Warnings | M012 |
| Meclizine HCL | MECLIZINE HCL 25MG CHEWABLE TABLETS | Aphena Pharma Solutions - Tennessee, LLC | 02d1af4d-d97d-4019-a5bf-3ec391238676 | 2025-01-09 | Warnings | M012 |
| HISTEX PD Drops New Formulation | TRIPROLIDINE HYDROCHLORIDE | Allegis Pharmaceuticals, LLC | 0c693f15-5d76-3dbf-e063-6294a90af9ac | 2025-01-08 | Warnings | M012 |
| DEXTROMETHORPHAN HBR 15 MG | DEXTROMETHORPHAN HBR 15 MG | AMZ789 LLC | e2175017-6a0d-0155-e053-2995a90a65d6 | 2025-01-08 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2637731 | {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } Pack | GPCK | 1ec3fc79-4f38-439f-99be-646b82231aa5 | 6 |
| 2637731 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) Pack | PSN | 1ec3fc79-4f38-439f-99be-646b82231aa5 | 6 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 1ec3fc79-4f38-439f-99be-646b82231aa5 | 6 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | 1ec3fc79-4f38-439f-99be-646b82231aa5 | 6 |
| 1431245 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 1ec3fc79-4f38-439f-99be-646b82231aa5 | 6 |
| 1369842 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 1ec3fc79-4f38-439f-99be-646b82231aa5 | 6 |
| 2637731 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 mL Oral Solution) Pack | SY | 1ec3fc79-4f38-439f-99be-646b82231aa5 | 6 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 1ec3fc79-4f38-439f-99be-646b82231aa5 | 6 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 1ec3fc79-4f38-439f-99be-646b82231aa5 | 6 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 1ec3fc79-4f38-439f-99be-646b82231aa5 | 6 |
| 1369842 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 1ec3fc79-4f38-439f-99be-646b82231aa5 | 6 |
| 1431245 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | 1ec3fc79-4f38-439f-99be-646b82231aa5 | 6 |
| 1369842 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | 1ec3fc79-4f38-439f-99be-646b82231aa5 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59779-597-02 | 59779059702 | 1 KIT in 1 CARTON (59779-597-02) * 355 mL in 1 BOTTLE (59779-763-40) * 355 mL in 1 BOTTLE (59779-603-40) | 1 kit | 2013-12-27 | 0000-00-00 | No | No | Current |
| 59779-603-40 | 59779060340 | 355 mL in 1 BOTTLE | 355 ml | Historical | ||||
| 59779-763-40 | 59779076340 | 355 mL in 1 BOTTLE | 355 ml | Historical |