Severe Cold and Flu
- Product NDC
- 42507-020
- 11-digit product format
- 425070020
- Labeler code
- 42507
- Product ID
- 42507-020_09897636-515d-4457-983f-c3e6e601c71a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- HyVee Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-09-08
- 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 | 42507-020 | 42507-020-34 | D | Discontinued by firm | 2026-10-12 |
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 | 42507-020-40 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 42507-020-34 | 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 | 42507-020-40 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 42507-020-34 | 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 | 42507-020-40 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 42507-020-34 | 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 | 42507-020-40 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 42507-020-34 | 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 | 42507-020-40 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 42507-020-34 | 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 | 42507-020-40 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 42507-020-34 | 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 | 42507-020-40 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 42507-020-34 | 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 | 42507-020-40 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 42507-020-34 | 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 | 42507-020-40 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 42507-020-34 | 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 | 42507-020-40 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 42507-020-34 | 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 | 42507-020-40 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 42507-020-34 | 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 | 42507-020-40 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 42507-020-34 | 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
- 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 |
|---|---|
| 96d8b6d1-8a51-41a4-80d3-fab61492b3cc | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42507-020-34 | Severe Cold and Flu | 237 mL in 1 BOTTLE | SOLUTION | 237 | 4 | |
| 42507-020-40 | Severe Cold and Flu | 355 mL in 1 BOTTLE | SOLUTION | 355 | 4 |
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 |
|---|---|---|---|---|---|---|
| WALMART DAYTIME AND NIGHTTIME MS SEVERE RELIEF VALUE PACK | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL | WAL-MART STORES INC | 888bd90a-a059-4814-bd65-6b735ecfaf3a | 2026-08-31 | Warnings | M012 |
| Severe Cold and Flu Daytime and Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Kroger | 49a98411-aa5a-6de3-e063-6294a90a148f | 2026-08-31 | Warnings | M012 |
| equate daytime nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDE | Sixarp, LLC | 5a5a6917-9fb5-e6ca-e063-6394a90af9dc | 2026-08-31 | Warnings | M012 |
| Zicam Intense Sinus Relief | OXYMETAZOLINE HYDROCHLORIDE | Church & Dwight Co., Inc. | d916f7ff-84b7-57ef-e053-2995a90a3efa | 2026-08-31 | Warnings | M012 |
| Afrin Original Nasal | OXYMETAZOLINE HYDROCHLORIDE | JC World Bell Wholesale Co., Inc. | ecfa14b8-a3f3-4569-b489-c9e1a51cf09e | 2026-08-31 | Warnings | M012 |
| Dextromethorphan HBr | DEXTROMETHORPHAN HBR | BIONPHARMA INC. | 5a5dde85-8785-8149-e063-6294a90a4d57 | 2026-08-31 | Warnings | M012 |
| Equate Nasal | OXYMETAZOLINE HCL | Sixarp, LLC | 5a5e2458-bab0-4931-e063-6394a90ad606 | 2026-08-31 | Warnings | M012 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEF | DEXTROMETHORPHAN HYDROBROMIDE AND HEXYLRESORCINOL | Reckitt Benckiser LLC | 8d670d91-9e22-45b9-b568-5b62c2133d32 | 2026-08-31 | Warnings | M012 |
| Daytime Cold and Flu Multi Symptom Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | e85b4c2a-d4e0-452c-9a08-fcc0ff6eaa21 | 2026-08-31 | Warnings | M012 |
| Daytime Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | 67849e09-2056-4013-98b1-d003ed3250a2 | 2026-08-31 | Warnings | M012 |
| MAX Tussin Mucus and Chest Congestion Sugar Free | GUAIFENESIN | Akron Pharma Inc. | 3b023b91-e703-4599-9864-96d8c328b45c | 2026-08-31 | Warnings | M012 |
| MAX Tussin Mucus and Chest Congestion | GUAIFENESIN | Akron Pharma Inc. | ac874a31-5556-4669-937f-dcb52aaecd8a | 2026-08-31 | Warnings | M012 |
| MAX Tussin Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Akron Pharma Inc. | e0ce4287-bfa1-4413-97c8-4fe2e39bda36 | 2026-08-31 | Warnings | M012 |
| Acetaminophen PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | United Natural Foods, Inc. dba UNFI | 24173e77-92ec-4a87-a471-d6867837c180 | 2026-08-31 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | DOLGENCORP, LLC | 69af44c2-390c-4223-889a-d5555aef5778 | 2026-08-28 | Warnings | M012 |
| Tussin DM Daytime | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 432d4833-2eaf-4f7c-b6b4-41043a6b7e2a | 2026-08-28 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Your Military Exchanges | 13fcc43c-bdda-4b65-b6d7-23b39e683651 | 2026-08-28 | Warnings, Adverse reactions | M012 |
| Multi-Symptom Allergy | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Walgreen Company | 5170c450-989d-44fa-ab38-86c78feae3b6 | 2026-08-28 | Warnings | M012 |
| Pain Reliever PM Extra strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Walgreens | 54cbbc5f-908b-47b2-b37f-3646354d3568 | 2026-08-27 | Warnings | M012 |
| Maximum Strength Mucus Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Hyvee Inc | 4e578c7a-88d4-e4cd-e063-6394a90aac44 | 2026-08-27 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | 96d8b6d1-8a51-41a4-80d3-fab61492b3cc | 4 |
| 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 | 96d8b6d1-8a51-41a4-80d3-fab61492b3cc | 4 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 96d8b6d1-8a51-41a4-80d3-fab61492b3cc | 4 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 96d8b6d1-8a51-41a4-80d3-fab61492b3cc | 4 |
| 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 | 96d8b6d1-8a51-41a4-80d3-fab61492b3cc | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42507-020-34 | 42507002034 | 237 mL in 1 BOTTLE | 237 ml | Historical | |||
| 42507-020-40 | 42507002040 | 355 mL in 1 BOTTLE (42507-020-40) | 355 ml | 2015-09-08 | No | No | Current |