severe cold and flu
- Product NDC
- 42507-511
- 11-digit product format
- 425070511
- Labeler code
- 42507
- Product ID
- 42507-511_9cb287b6-e577-4209-98b4-be6f63245cc9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- HyVee Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-01-28
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
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 | 325 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/15mL |
| GUAIFENESIN | 200 mg/15mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/15mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1369842 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 987f908b-7af7-4705-bfb4-c48d771c380d | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42507-511-40 | severe cold and flu | 355 mL in 1 BOTTLE | SOLUTION | 355 | 2 |
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 |
|---|---|---|---|---|---|---|
| foster and thrive daytime severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Sportpharm LLC | 51e34704-5e6b-4e80-836c-ddbc24a451b2 | 2026-03-06 | Warnings | M012 |
| Medi-First Plus Sinus Decongestant | PHENYLEPHRINE HYDROCHLORIDE | Sportpharm LLC | 20f58b0b-c123-477f-a62c-fa5423e23f93 | 2026-03-06 | Warnings | M012 |
| Nasal Decongestant PE Maximum Strength | PHENYLEPHRINE HCL | Sportpharm LLC | 7f4e8d37-8c6b-4849-b86c-4335a0bcac1c | 2026-03-06 | Warnings | M012 |
| Daytime and Nighttime Cold and Flu Kit | DAYTIME AND NIGHTTIME COLD AND FLU KIT | Allegiant Health | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 2026-03-06 | Warnings | M012 |
| Nasal Decongestant PE | PHENYLEPHRINE HCL | Better Living Brands, LLC | 0153294d-7f52-4d92-8db8-daeca3e29a3b | 2026-03-06 | Warnings | M012 |
| Mucus DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Meijer Distribution, Inc. | 87cf4f25-b0e9-4f8b-bde3-0d0f26e2120e | 2026-03-06 | Warnings | M012 |
| RYNEX PE | BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | EDWARDS PHARMACEUTICALS, INC. | 77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef | 2026-03-05 | Warnings | M012 |
| Childrens Cold and Allergy | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Best Choice (Valu Merchandisers Company) | 042f9449-4af0-4b15-bb3e-236afeb1e11f | 2026-03-05 | Warnings | M012 |
| Mucus Relief | GUAIFENESIN | Amerisource Bergen | 087a3a0b-8d3f-45ed-8807-0af47b446cac | 2026-03-05 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MG | NUVICARE LLC | 6c4bc7d1-09d9-4311-8457-a1d47ab02a5a | 2026-03-05 | Warnings | M012 |
| Allergy Relief childrens | DIPHENHYDRAMINE HCL | WALMART INC. | dceb99a9-4aa3-4acc-b632-9a4ba8c87919 | 2026-03-04 | Warnings | M012 |
| AMAZON Childrens Multi Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | AMAZON.COM SERVICES LLC | 26101105-a6cf-4b51-a639-9d078542fea3 | 2026-03-04 | Warnings | M012 |
| Allergy Relief Childrens | DIPHENHYDRAMINE HCL | Major Pharmaceuticals | 3a976e90-c6af-4414-984e-9987158c9e98 | 2026-03-04 | Warnings | M012 |
| Childrens Allergy | DIPHENHYDRAMINE HCL | Best Choice (Valu Merchandisers Company) | 714e93ec-0aa9-4be2-9311-399e82f148e0 | 2026-03-04 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Best Choice (Valu Merchandisers Company) | d1131759-dd2e-4c06-bb73-92dd975f5511 | 2026-03-04 | Warnings | M012 |
| AMAZON Maximim Strength Adult Nighttime Cough DM | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | AMAZON.COM SERVICES LLC | 6bbe8cc9-7a60-4476-b5cf-b13c5bebff26 | 2026-03-04 | Warnings | M012 |
| Severe Cold and Flu Daytime, Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 5a1dfaf3-370d-4ac7-a72d-a48863a35741 | 2026-03-04 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Walgreen Company | c5cb09d4-c049-461c-8898-2c5bb6a8a138 | 2026-03-04 | Warnings | M012 |
| Tussin CF | DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL | WinCo Foods, LLC | 3d96d6d0-8c04-43bb-aed0-4cd00cdf3456 | 2026-03-04 | Warnings | M012 |
| DayTime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | H E B | e2994c0f-add8-4f75-a6d2-24cd2af271e4 | 2026-03-03 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 987f908b-7af7-4705-bfb4-c48d771c380d | 2 |
| 1369842 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 987f908b-7af7-4705-bfb4-c48d771c380d | 2 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 987f908b-7af7-4705-bfb4-c48d771c380d | 2 |
| 1369842 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 987f908b-7af7-4705-bfb4-c48d771c380d | 2 |
| 1369842 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | 987f908b-7af7-4705-bfb4-c48d771c380d | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42507-511-40 | 42507051140 | 355 mL in 1 BOTTLE (42507-511-40) | 355 ml | 2026-01-28 | No | No | Current |