Daytime Severe Cold and Flu
- Product NDC
- 41226-774
- 11-digit product format
- 412260774
- Labeler code
- 41226
- Product ID
- 41226-774_17c36d96-1b78-a612-e063-6394a90ae9c9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Kroger
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-04-30
- Substance
- PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 5; 325; 200; 10 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
- 2026-12-31
- 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
- Daytime Severe Cold and Flu
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/15mL |
| ACETAMINOPHEN | 325 mg/15mL |
| GUAIFENESIN | 200 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/15mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 04JA59TNSJ | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1369842 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 10b0e0a0-b878-0a9a-e063-6394a90a20e0 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41226-774-01 | Daytime Severe Cold and Flu | 354 mL in 1 BOTTLE | LIQUID | 354 | 2 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Poly-Vent IR | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Poly Pharmaceuticals, Inc. | ce0d8c45-446a-4df4-a36b-5000ba69d30d | 2024-11-09 | Warnings | M012 |
| basic care tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Amazon.com Services LLC | 306d5914-03ed-410a-9345-c54ba604e991 | 2024-11-09 | Warnings | M012 |
| care one nasal original | OXYMETAZOLINE HYDROCHLORIDE | American Sales Company | a0c35e06-c9e9-438e-8224-d4760b6e2aff | 2024-11-09 | Warnings | M012 |
| adult tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Walgreen Company | 34174507-cf2e-4ed4-85ec-f915d4b910df | 2024-11-08 | Warnings | M012 |
| Childrens Benadryl Chewables | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | b08f71d8-a06c-41ba-8ed1-fbc41dbc1919 | 2024-11-08 | Warnings | M012 |
| SUDAFED PE SINUS CONGESTION | DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | a38fdfb8-db89-487f-9b68-aa9152b91f5f | 2024-11-08 | Warnings | M012 |
| SUDAFED Sinus Congestion | PSEUDOEPHEDRINE HYDROCHLORIDE | Kenvue Brands LLC | c05d7e27-6821-468f-b27d-9c0b02a07b0f | 2024-11-08 | Warnings | M012 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 2884d2dc-2d4a-4ca6-ab73-688a80b428eb | 2024-11-08 | Warnings | M012 |
| Extra Strength TYLENOL Cold plus Flu Multi-Action Day/Night | ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND CHLORPHENIRAMINE MALEATE | Kenvue Brands LLC | 712ba011-79aa-469b-9f0f-04a0b4b705bd | 2024-11-08 | Warnings | M012 |
| SUDAFED PE Pressure Plus Pain | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 8538c291-9ce9-4866-b268-f4cbdb52f5bd | 2024-11-08 | Warnings | M012 |
| Childrens Sudafed Nasal Decongestant | PSEUDOEPHEDRINE HYDROCHLORIDE | Kenvue Brands LLC | 52e9307b-ad38-4f65-bb2f-4fa262e82010 | 2024-11-08 | Warnings | M012 |
| Benadryl Allergy Plus Congestion | DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 685b51d3-cc25-47b2-ac8a-368924f43137 | 2024-11-08 | Warnings | M012 |
| Sudafed PE Sinus Pressure Plus Pain | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 60183922-bfd3-4377-884a-51b2f0a4c93a | 2024-11-08 | Warnings | M012 |
| Sudafed PE Sinus Congestion | PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 2ca08917-1a75-4365-8520-c083e6a4225a | 2024-11-08 | Warnings | M012 |
| SUDAFED PE Head Congestion Plus Mucus | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | f0739186-41b9-4761-adf7-08101b30a18e | 2024-11-08 | Warnings | M012 |
| SUDAFED PE Head Congestion Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 1e528f78-0ced-4a06-935a-84056c921727 | 2024-11-08 | Warnings | M012 |
| TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPack | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 657a1e59-104c-4152-b2c9-00a8b82dc78e | 2024-11-08 | Warnings | M012 |
| Tylenol Cold plus Flu Severe and Tylenol Cold Max | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 47c61858-72ce-409b-a3af-a63620cf7d13 | 2024-11-08 | Warnings | M012 |
| Childrens Benadryl Allergy Plus Congestion | DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | b8b75904-3806-4258-89c1-d6ff486ed41c | 2024-11-08 | Warnings | M012 |
| Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 3-Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 464de5de-0e7a-41d6-875f-dd0e5fe7893c | 2024-11-08 | 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 | 10b0e0a0-b878-0a9a-e063-6394a90a20e0 | 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 | 10b0e0a0-b878-0a9a-e063-6394a90a20e0 | 2 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 10b0e0a0-b878-0a9a-e063-6394a90a20e0 | 2 |
| 1369842 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 10b0e0a0-b878-0a9a-e063-6394a90a20e0 | 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 | 10b0e0a0-b878-0a9a-e063-6394a90a20e0 | 2 |
| 2637731 | {1 (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) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } Pack | GPCK | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 2637731 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) Pack | PSN | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 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 | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 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 | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 2637731 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 mL Oral Solution) Pack | SY | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 1369842 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 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 | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 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 | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 41226-774-01 | 41226077401 | 354 mL in 1 BOTTLE (41226-774-01) | 354 ml | 2024-04-30 | No | No | Current |