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 | 2026-10-16 | |
| excluded package | package | 59779-335 | 59779-335-34 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 59779-335 | 59779-335-38 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 59779-335 | 59779-335-50 | D | Discontinued by firm | 2026-10-16 |
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 |
|---|---|---|---|---|---|---|
| Maximum Strength Mucus Relief DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Wal-Mart Stores,Inc., | a748d5ab-901c-47bb-8437-997542ecebfe | 2025-10-28 | Warnings | M012 |
| Nighttime Childrens Multi Symptoms Cold and Cough Multi-Symptom Relief | CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE | WAL-MART STORES,INC. | 68a68574-0fcb-4569-be57-d9aee5f62bea | 2025-10-28 | Warnings | M012 |
| Maximum Strength Mucus Relief Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores,Inc., | 635009a1-6154-4c62-a4be-d4f32c2cef8d | 2025-10-28 | Warnings | M012 |
| Publix Maximum Strength | OXYMETAZOLINE HYDROCHLORIDE | PUBLIX SUPER MARKETS, INC | cf49a06d-f095-48bf-bcd2-a410066ff9af | 2025-10-28 | Warnings | M012 |
| Publix | OXYMETAZOLINE HYDROCHLORIDE | PUBLIX SUPER MARKETS, INC | 283e42b9-173c-4deb-9377-ff649efc177f | 2025-10-28 | Warnings | M012 |
| Publix Extra Moisturizing | OXYMETAZOLINE HYDROCHLORIDE | PUBLIX SUPER MARKETS, INC | eae83b75-9d5a-4100-9304-629e54ef7752 | 2025-10-28 | Warnings | M012 |
| Publix | PHENYLEPHRINE HYDROCHLORIDE | PUBLIX SUPER MARKETS, INC | f10e120d-f0b7-4c51-b29b-e8cdbb1456f3 | 2025-10-28 | Warnings | M012 |
| Family Care Nasal Relief | OXYMETAZOLINE HYDROCHLORIDE | United Exchange Corp | 6d0f8e9e-0503-522b-e053-2a91aa0aca35 | 2025-10-28 | Warnings | M012 |
| Family Care Nasal Relief | OXYMETAZOLINE HYDROCHLORIDE | United Exchange Corp | 6d0eef2f-f546-d769-e053-2991aa0a8fe4 | 2025-10-28 | Warnings | M012 |
| Sinus Plus Headache | ACETAMINOPHEN, PHENYLEPHRINE HCL | Kroger Company | b622b6cb-f756-439e-8684-d45ee1ea75ab | 2025-10-28 | Warnings | M012 |
| Tussin DM Cough and Chest Congestion Adult | DEXTROMETHORPHAN HBR, GUAIFENESIN | P & L Development, LLC | 4af67ba7-8892-442c-b9fb-80aba9140e05 | 2025-10-28 | Warnings | M012 |
| No Drip Nasal Mist Nasal Decongestant Severe Congestion | OXYMETAZOLINE HYDROCHLORIDE | Wal-Mart Stores,Inc., | 994fa270-65bb-4097-b88a-d5ce3c0e1c79 | 2025-10-27 | Warnings | M012 |
| Dye Free Childrens Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | WAL-MART STORES INC. | 3652ee94-b762-4100-a305-5acbec5f795a | 2025-10-27 | Warnings | M012 |
| Maximum Strength Mucus Relief Cold,Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL | Wal-Mart Stores,Inc., | 2fd5be4f-2bb6-4241-9e0f-be7610ae2fdc | 2025-10-27 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | United Natural Foods, Inc. dba UNFI | 4517c7ef-156c-42b8-a2da-165e936f0837 | 2025-10-27 | Warnings | M012 |
| Allergies MY CHILD NEEDS HELP WITH | DIPHENHYDRAMINE HCL | Unconditional Love | 5ad293e9-0a4b-4923-8a91-f01450726828 | 2025-10-27 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Cardinal Health 110, LLC. DBA Leader | 933a54d3-196d-4c5d-b26f-d18b2d2ba1df | 2025-10-27 | Warnings | M012 |
| Banophen | DIPHENHYDRAMINE HCL | Major Pharmaceuticals | 69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c1 | 2025-10-27 | Warnings | M012 |
| basic care daytime severe cold and flu nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | Amazon.com Services LLC | 4a9fd615-b7d3-452c-ac40-d9189124faaa | 2025-10-24 | Warnings | M012 |
| allergy childrens | DIPHENHYDRAMINE HYDROCHLORIDE | Meijer Distribution Inc | 622b12fa-455c-4432-a9a2-698a929bbd68 | 2025-10-24 | 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 |