Nighttime Cold and Flu Relief
- Product NDC
- 59779-335
- 11-digit product format
- 597790335
- Labeler code
- 59779
- Product ID
- 59779-335_3a7d9551-e73e-462c-b69a-f241de84ac6a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- CVS Pharmacy
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-08-16
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- 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]
- 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 | 59779-335 | 59779-335-30 | D | Discontinued by firm | 2026-10-23 | |
| excluded package | package | 59779-335 | 59779-335-34 | D | Discontinued by firm | 2026-10-23 | |
| excluded package | package | 59779-335 | 59779-335-38 | D | Discontinued by firm | 2026-10-23 | |
| excluded package | package | 59779-335 | 59779-335-50 | D | Discontinued by firm | 2026-10-23 |
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 | 59779-335-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 59779-335-34 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 59779-335-50 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 59779-335-38 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 59779-335-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 59779-335-34 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 59779-335-50 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 59779-335-38 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 59779-335-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 59779-335-34 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 59779-335-50 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 59779-335-38 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 59779-335-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 59779-335-34 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 59779-335-50 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 59779-335-38 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 59779-335-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 59779-335-34 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 59779-335-50 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 59779-335-38 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 59779-335-30 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 59779-335-34 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 59779-335-50 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 59779-335-38 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 59779-335-30 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 59779-335-34 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 59779-335-50 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 59779-335-38 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 59779-335-30 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 59779-335-34 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 59779-335-50 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 59779-335-38 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 59779-335-30 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 59779-335-34 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 59779-335-50 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 59779-335-38 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 59779-335-30 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 59779-335-34 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 59779-335-50 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 59779-335-38 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 59779-335-30 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 59779-335-50 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 59779-335-38 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 59779-335-30 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 59779-335-50 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 59779-335-38 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Nighttime Cold and Flu Relief
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1043400 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c5dd40e5-b4e2-4963-9a53-b71da1ed5510 | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59779-335-30 | Nighttime Cold and Flu Relief | 177 mL in 1 BOTTLE | SOLUTION | 177 | 8 | |
| 59779-335-34 | Nighttime Cold and Flu Relief | 237 mL in 1 BOTTLE | SOLUTION | 237 | 8 | |
| 59779-335-38 | Nighttime Cold and Flu Relief | 295 mL in 1 BOTTLE | SOLUTION | 295 | 8 | |
| 59779-335-40 | Nighttime Cold and Flu Relief | 355 mL in 1 BOTTLE | SOLUTION | 355 | 8 | |
| 59779-335-50 | Nighttime Cold and Flu Relief | 355 mL in 1 BOTTLE | SOLUTION | 355 | 8 | |
| 59779-335-50 | Nighttime Cold and Flu Relief | 2 in 1 PACKAGE | SOLUTION | 2 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59779-335-34 | ML - Milliliter | 59779-335 | 7974239f-38a1-47aa-864a-c8c06090c04d | 1 | 2020-05-08 |
| 59779-335-40 | ML - Milliliter | 59779-335 | 0b6b33f1-4bc9-4a7e-9e54-a2f521e3aa40 | 1 | 2022-06-06 |
| 59779-335-50 | ML - Milliliter | 59779-335 | f052481f-a3a0-4fc1-8ae2-427d42b7396d | 1 | 2022-06-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59779-335 | NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY] | 8 | Current NDC, Legacy NDC, 6 package rows | 20241025_c5dd40e5-b4e2-4963-9a53-b71da1ed5510.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 |
|---|---|---|---|---|---|---|
| Tussin Mucus and Chest Congestion Sugar Free | GUAIFENESIN | AARNA USA, Inc. | 6e488782-0138-436d-a9f0-0ec5bc9daedd | 2023-05-15 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN | KROGER COMPANY | 813b1db2-a177-77c6-e053-2a91aa0ac73b | 2023-01-17 | Warnings | M012 |
| MUCUS RELIEF DM | DEXTROMETHORPHAN HBR/GUAIFENESIN | KROGER COMPANY | 813baf42-edb0-33a9-e053-2a91aa0a8599 | 2023-01-17 | Warnings | M012 |
| Daytime Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | H-E-B | db19b8c7-0334-0664-e053-2a95a90ad61f | 2023-01-14 | Warnings | M012 |
| Nightime | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | H-E-B | db44560b-da02-74c9-e053-2a95a90af0b6 | 2023-01-13 | Warnings | M012 |
| DAYTIME COLD AND FLU Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | dbf5656b-9105-871b-e053-2995a90a4941 | 2023-01-03 | Warnings | M012 |
| DAYTIME-NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | KROGER | a2508699-08c0-4a22-e053-2a95a90a8a6d | 2022-11-02 | Warnings | M012 |
| GUAIFENESIN | GUAIFENESIN | PAI Holdings, LLC dba PAI Pharma | c2e53fb5-2798-47c8-9285-d1077d46e629 | 2022-06-14 | Warnings | M012 |
| Mucus Relief DM | MUCUS RELIEF DM | TopCo Associates, LLC | 71674a9b-89ed-43d1-aadb-b9311fdfbdf9 | 2022-06-07 | Warnings | M012 |
| Daytime Nighttime Cold and Flu Relief Combo Pack | DAYTIME NIGHTTIME COLD AND FLU | Allegiant Health | fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 | 2022-05-19 | Warnings | M012 |
| Mucus Relief DM Immediate Release | MUCUS RELIEF DM | Good Sense | 26a199bf-57e5-4f36-b40c-83a1187e4870 | 2022-05-18 | Warnings | M012 |
| Mucus Relief DM Immediate Release | MUCUS RELIEF DM | Allegiant Health | 731f8608-ad5b-491e-a4d4-2bb0c423fed5 | 2022-05-18 | Warnings | M012 |
| Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | OPMX LLC | b3c229a4-c772-70fb-e053-2a95a90a72db | 2022-03-11 | Warnings | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | Good Sense | f88e2654-8e97-4cf6-9c36-01aeb51a9102 | 2021-11-30 | Warnings | M012 |
| Cold Medicine | COLD MEDICINE | Allegiant Health | 443fbc44-2c33-4316-ad31-dcc5a5aa8f52 | 2021-11-23 | Warnings | M012 |
| Decongestant PE Non Drowsy | PHENYLEPHRINE HCL | Allegiant Health | 7a3098b4-381c-4f32-97a7-87b53fd64428 | 2021-06-16 | Warnings | M012 |
| Mucus Relief Immediate Release | GUAIFENESIN 400MG | Good Sense | e7c68746-7ec0-46cf-b4a3-174fab819b5e | 2021-05-05 | Warnings | M012 |
| Mucus Relief Immediate Release | GUAIFENESIN 400MG | TopCo Associates, LLC | 7d91c6ab-d161-42b9-b353-0aa8f59619f8 | 2021-01-21 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MG | Allegiant Health | bed5f9dc-45ea-4e90-86c6-86599b6f3861 | 2020-11-16 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN | Allegiant Health | b97126d7-847d-483e-b3d1-e2b61ab1743f | 2020-11-11 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | c5dd40e5-b4e2-4963-9a53-b71da1ed5510 | 8 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | c5dd40e5-b4e2-4963-9a53-b71da1ed5510 | 8 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | c5dd40e5-b4e2-4963-9a53-b71da1ed5510 | 8 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | c5dd40e5-b4e2-4963-9a53-b71da1ed5510 | 8 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | c5dd40e5-b4e2-4963-9a53-b71da1ed5510 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59779-335-30 | 59779033530 | 177 mL in 1 BOTTLE (59779-335-30) | 177 ml | 2011-09-02 | 0000-00-00 | No | No | Current |
| 59779-335-34 | 59779033534 | 237 mL in 1 BOTTLE (59779-335-34) | 237 ml | 2012-07-26 | 0000-00-00 | No | No | Current |
| 59779-335-38 | 59779033538 | 295 mL in 1 BOTTLE (59779-335-38) | 295 ml | 2011-09-08 | 0000-00-00 | No | No | Current |
| 59779-335-40 | 59779033540 | 355 mL in 1 BOTTLE (59779-335-40) | 355 ml | 2011-08-16 | 0000-00-00 | No | No | Current |
| 59779-335-50 | 59779033550 | 2 BOTTLE in 1 PACKAGE (59779-335-50) > 355 mL in 1 BOTTLE | 2 bottle | 2011-08-16 | 0000-00-00 | No | No | Current |