Severe Nighttime
- Product NDC
- 59779-763
- 11-digit product format
- 597790763
- Labeler code
- 59779
- Product ID
- 59779-763_95083b8c-a3fb-494d-8fff-763656e40202
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- CVS Pharmacy
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-12-27
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 59779-763 | 59779-763-34 | D | Discontinued by firm | 2026-11-13 | |
| excluded package | package | 59779-763 | 59779-763-50 | D | Discontinued by firm | 2026-11-13 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 59779-763-34 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 59779-763-50 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 59779-763-34 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 59779-763-50 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 59779-763-34 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 59779-763-50 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 59779-763-34 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 59779-763-50 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 59779-763-34 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 59779-763-50 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 59779-763-34 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 59779-763-50 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 59779-763-34 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 59779-763-50 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 59779-763-34 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 59779-763-50 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 59779-763-34 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 59779-763-50 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 59779-763-34 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 59779-763-50 | ad56d346431e… | cc804d4bbf1e… |
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
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1431245 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d40d6fd1-3f84-40ae-ab7e-04569eb41617 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59779-763-34 | Severe Nighttime | 237 mL in 1 BOTTLE | SOLUTION | 237 | 6 | |
| 59779-763-40 | Severe Nighttime Severe Daytime | 355 mL in 1 BOTTLE | SOLUTION | 355 mL | 650 mg in 30mL | 6 |
| 59779-763-40 | Severe Nighttime | 355 mL in 1 BOTTLE | SOLUTION | 355 | 6 | |
| 59779-763-50 | Severe Nighttime | 2 in 1 PACKAGE | SOLUTION | 2 | 6 | |
| 59779-763-50 | Severe Nighttime | 355 mL in 1 BOTTLE | SOLUTION | 355 | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59779-763 | SEVERE NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY] | 6 | Current NDC, Legacy NDC, 4 package rows | 20241101_d40d6fd1-3f84-40ae-ab7e-04569eb41617.zip |
| 59779-763 | SEVERE NIGHTTIME SEVERE DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY] | 5 | Current NDC, Legacy NDC | 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 |
|---|---|---|---|---|---|---|
| Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | e7cf7c5d-5c9a-4201-9e30-1cd616071855 | 2024-04-06 | Warnings | M012 |
| Robitussin Medi-Soothers | DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL | Haleon US Holdings LLC | 4c3d57e3-e40b-41ca-b44b-5f4c5f4dbae5 | 2024-04-06 | Warnings | M012 |
| DEXTROMETHORPHAN HBR, GUAIFENESIN | DEXTROMETHORPHAN HBR, GUAIFENESIN | OPMX LLC | 9a16e7f3-78aa-0b01-e053-2a95a90ab19c | 2024-04-05 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime Honey Ginger | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 44404c6a-8031-4f4b-a48e-3739a11a0d2c | 2024-04-05 | Warnings | M012 |
| Activcin | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | OPMX LLC. | e06a4d72-cc8d-fd9d-e053-2995a90a7a76 | 2024-04-05 | Warnings | M012 |
| Coldtac Plus Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | OPMX LLC. | ff5ce5c6-a03f-2ad3-e053-6394a90a99f6 | 2024-04-05 | Warnings | M012 |
| Leader Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Cardinal Health 110,Inc | 98bf8e84-b555-4b5a-90a0-7837a5560289 | 2024-04-03 | Warnings | M012 |
| DAYTIME COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Advanced Rx LLC | 38299cf3-e884-4676-8cc4-6dd64e7d023c | 2024-03-30 | Warnings | M012 |
| NIGHTTIME COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Advanced Rx LLC | d1542362-19c5-4470-89e8-87d26e2ca8ed | 2024-03-30 | Warnings | M012 |
| ANTIGRIP Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Pharmadel LLC | 12de30fd-95b6-f16d-e063-6294a90aeba2 | 2024-03-27 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | 0044c53c-11dd-41a9-a5d9-622dd8b1c144 | 2024-03-27 | Warnings | M012 |
| Codeine-Guaifenesin | CODEINE PHOSPHATE AND GUAIFENESIN | Bryant Ranch Prepack | 9812056b-736e-40c5-ae60-21dd9221397c | 2024-03-22 | Warnings | M012 |
| Tussin CF | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Best Choice (Valu Merchandisers Company) | 1b7b5811-722e-4c4a-844d-c05fa5cfb2e5 | 2024-03-21 | Warnings | M012 |
| Daytime and Nighttime Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL / ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreens | da2a77c3-7d0f-157b-e053-2995a90a951a | 2024-03-19 | Warnings | M012 |
| Robitussin Medi-Soothers | DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL | Haleon US Holdings LLC | 6bec225e-a203-4866-b0db-b76f73a6ae25 | 2024-03-19 | Warnings | M012 |
| Cold and Flu Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 06d47104-a8ca-48cc-b27e-08c9d018c37b | 2024-03-19 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | b80dae7f-ed2d-4a9e-bef9-f1ed8add0174 | 2024-03-19 | Warnings | M012 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | WALGREENS | c945c35e-de0d-0fd6-e053-2995a90a1fbf | 2024-03-19 | Warnings | M012 |
| Daytime Nighttime Sinus Relief Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL/ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE,PHENYLEPHRINE HCL | Walgreens | da046b01-707c-326a-e053-2995a90a0927 | 2024-03-19 | Warnings | M012 |
| DAYTIME NIGHTTIME SEVERE COLD AND FLU Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL / ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreens | da2b0276-9ab0-38e6-e053-2a95a90a54d8 | 2024-03-19 | 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 | d40d6fd1-3f84-40ae-ab7e-04569eb41617 | 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 | d40d6fd1-3f84-40ae-ab7e-04569eb41617 | 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 | d40d6fd1-3f84-40ae-ab7e-04569eb41617 | 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 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | d40d6fd1-3f84-40ae-ab7e-04569eb41617 | 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 | d40d6fd1-3f84-40ae-ab7e-04569eb41617 | 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 |
|---|---|---|---|---|---|---|---|---|
| 59779-763-34 | 59779076334 | 237 mL in 1 BOTTLE (59779-763-34) | 237 ml | 2013-12-27 | 0000-00-00 | No | No | Current |
| 59779-763-40 | 59779076340 | 355 mL in 1 BOTTLE (59779-763-40) | 355 ml | 2013-12-27 | 0000-00-00 | No | No | Current |
| 59779-763-50 | 59779076350 | 2 in 1 PACKAGE | Historical |