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 |
|---|---|---|---|---|---|---|
| Panadol Cold and Flu Night | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 3417993d-8e3c-23d6-e063-6394a90a7d50 | 2026-04-29 | Warnings | M012 |
| Halls Sugar Free Mountain Menthol | MENTHOL | Mondelez Global LLC | 509f233e-ff01-8927-e063-6394a90a9929 | 2026-04-29 | Warnings | M012 |
| Broncomiel Adults | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Pharmadel LLC | 509c61d3-ae16-be5c-e063-6294a90a68da | 2026-04-29 | Warnings | M012 |
| Mucus Relief DM Max Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | TOP CARE (Topco Associates LLC) | aa1eb90c-e565-455f-8978-6f2f9e00a814 | 2026-04-29 | Warnings | M012 |
| Tussin Cough and Chest Congestion DM adult | DEXTROMETHORPHAN HBR, GUAIFENESIN | Harris Teeter, LLC | e1280355-da81-489f-9bd2-ffea9a68010c | 2026-04-29 | Warnings | M012 |
| Mucus Relief Childrens | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TOPCO ASSOCIATES LLC | 7b095ec5-9951-4491-9b68-7ac0a7f10053 | 2026-04-29 | Warnings | M012 |
| Mucus Relief Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TOP CARE (Topco Associates LLC) | 98dd0ba6-0109-46b2-92df-11a030984240 | 2026-04-28 | Warnings | M012 |
| Pain, Headache and Congestion | ACETAMINOPHEN, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 41a77cbb-6a4d-46a4-ab27-c7affa2cc682 | 2026-04-28 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu and Congestion Severe Fast Dissolve | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | dd7da15a-4e0b-405f-e053-2995a90a06d2 | 2026-04-28 | Warnings | M012 |
| CAREONE CHILDRENS COLD COUGH | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Retail Business Services, LLC | 382f7d51-ceb8-4bdf-9bd5-440b50c65cd3 | 2026-04-28 | Warnings | M012 |
| Cold and Flu Daytime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L.N.K. International, Inc. | 1a520b4f-6a4b-4e37-94c5-9387f2e4c34a | 2026-04-27 | Warnings | M012 |
| Childrens Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Kroger | 49a7cd2a-8c0e-2196-e063-6294a90a134a | 2026-04-27 | Warnings | M012 |
| Guaifenesin,Dextromethorphan Hbr | GUAIFENESIN,DEXTROMETHORPHAN HBR | Softgel Healthcare Pvt Ltd | 3e5d978f-cc70-60a5-e063-6394a90a67d3 | 2026-04-27 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE | Softgel Healthcare Pvt Ltd | 36ced59c-12dc-441f-e063-6294a90a3239 | 2026-04-27 | Warnings | M012 |
| Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL | Softgel Healthcare Private Limited | 30ab39f3-27cc-5728-e063-6394a90a9cbe | 2026-04-27 | Warnings | M012 |
| Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Softgel Healthcare Private Limited | 353f71f7-81e0-08c2-e063-6294a90acb49 | 2026-04-27 | Warnings | M012 |
| Acetaminophen, Dextromethorphan HBr ,Guaifenesin | ACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESIN | Softgel Healthcare Pvt Ltd | 353ef34f-760d-ae92-e063-6294a90a5b4a | 2026-04-27 | Warnings | M012 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 0203d919-dc1f-cca0-e063-6394a90aa1aa | 2026-04-27 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu and Congestion Severe Fast Dissolve | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 507214ad-1e06-fe21-e063-6294a90a59cd | 2026-04-27 | Warnings | M012 |
| ALKA SELTZER COLD Cold Congestion Severe Day Night Fast Dissolve | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 50738a43-7299-270c-e063-6294a90af2cc | 2026-04-27 | 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 |