Severe Cold and Flu
- Product NDC
- 42507-597
- 11-digit product format
- 425070597
- Labeler code
- 42507
- Product ID
- 42507-597_7172be88-9cab-4bf7-9882-e41ac912ea4c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
- Dosage form
- KIT
- Labeler
- HyVee Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-05-19
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 42507-597-02 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 42507-597-02 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 42507-597-02 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 42507-597-02 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 42507-597-02 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 42507-597-02 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 42507-597-02 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 42507-597-02 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 42507-597-02 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 42507-597-02 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 42507-597-02 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 42507-597-02 | 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
- Severe Cold and Flu
- Brand name suffix
- Nighttime Daytime
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d4bcfabb-a054-4f53-8dc9-d361a03558b8 | Available on FDA.report |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Seacall Nasal Spray. | NASAL SPRAY | Guangdong Quadrant Ecological Technology Co., Ltd. | 1f12618b-7461-fb47-e063-6294a90af753 | 2026-01-23 | Warnings | M012 |
| daytime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | ecf7d210-102c-4053-81f6-67116de6cf7b | 2026-01-23 | Warnings | M012 |
| Good Neighbor Pharmacy Day Time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amerisource Bergen | 44f9255b-0bf9-4573-ac9c-410acb515bc2 | 2026-01-23 | Warnings | M012 |
| Daytime cold and flu non drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Meijer Distribution Inc | 29caa3a7-7fe6-4134-a9b0-49bdb9280ca7 | 2026-01-23 | Warnings | M012 |
| good neighbor pharmacy night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Amerisource Bergen | e2b5c27e-ca5f-4503-a3ce-c86e1d8070a7 | 2026-01-23 | Warnings | M012 |
| RAYO ACTIVE ICE | MENTHOL, CAMPHOR | Quimicas Handal de Centroamerica SA de CV | 09e4a36b-020a-c5b1-e063-6394a90a3e31 | 2026-01-22 | Warnings | M012 |
| DRX CHOICE NIGHTTIME COLD and FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Raritan Pharmaceuticals Inc. | f466fc0e-3384-4884-832e-99bf1fdcf899 | 2026-01-21 | Warnings | M012 |
| Tussin DM | DEXTROMETHORPHAN HBR GUAIFENESIN | Strategic Sourcing Services LLC | 84750bfb-9e94-40a3-b731-21799f5e4fd1 | 2026-01-20 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Amerisource Bergen | 0b58990f-2246-408e-9365-51f56bb6766c | 2026-01-20 | Warnings | M012 |
| NightTime Cold and Flu Multi Symptom | ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | a8460fc9-2d08-4e5f-8dd3-5135ecda5923 | 2026-01-20 | Warnings | M012 |
| Mucus Relief DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Family Dollar Services Inc | 0a651316-623e-41eb-ab3a-641f5d807425 | 2026-01-20 | Warnings | M012 |
| Walgreens Maximum Strength Non Drowsy Day and Night Cold and Flu | WALGREENS MAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLU | Walgreens | 579c47c8-6366-4785-9680-d3986ce9641d | 2026-01-19 | Warnings | M012 |
| Walgreens Maximum Strength Non-Drowsy Day and Night Sinus and Cold | WALGREENS MAXIMUM STRENGTH NON-DROWSY DAY AND NIGHT SINUS AND COLD | Walgreens | dd61c9d3-0b70-450e-9525-282710b383cc | 2026-01-19 | Warnings | M012 |
| Sinus Severe Ultra Fine Mist | OXYMETAZOLINE HYDROCHLORIDE. | VIVUNT PHARMA LLC | 48bf7422-38ef-d4b4-e063-6294a90aa3ab | 2026-01-19 | Warnings | M012 |
| Cold and Flu Daytime, Nighttime, Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreens | fc670515-a820-4ea7-8786-8ae710798b31 | 2026-01-19 | Warnings | M012 |
| Allergy Relief Dye Free | DIPHENHYDRAMINE HCL | WALGREENS | 9dece7b1-00b1-2499-e053-2a95a90a0be3 | 2026-01-19 | Warnings | M012 |
| SEVERE COLD AND FLU DAYTIME NON DROWSY and NIGHTTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE / ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Walgreens | 2dba2bec-e0e3-4910-89c5-ebc093e05bec | 2026-01-19 | Warnings | M012 |
| SEVERE DAYTIME COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Walgreens | ca3c1eb4-6099-5e5f-e053-2995a90ab61b | 2026-01-19 | Warnings | M012 |
| SEVERE NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | WALGREENS | fe6dff90-18f1-491e-84b9-cc74bb1831ba | 2026-01-19 | Warnings | M012 |
| Daytime Non-Drowsy Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Walgreens Company | ec8c73d5-b190-432a-92c6-68ea0fc86ea6 | 2026-01-19 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42507-597-02 | 42507059702 | 1 KIT in 1 CARTON (42507-597-02) * 355 mL in 1 BOTTLE * 355 mL in 1 BOTTLE | 1 kit | 2014-05-19 | No | No | Current |