Cold and Flu
- Product NDC
- 0363-8078
- 11-digit product format
- 003638078
- Labeler code
- 0363
- Product ID
- 0363-8078_c296f3f1-48d3-486d-80d1-d6c1daf5e56b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Triprolidine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Walgreen Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-10-21
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
- Active strength
- 650; 20; 10; 2.5 mg/20mL; mg/20mL; mg/20mL; mg/20mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [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
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
- Cold and Flu
- Brand name suffix
- Severe
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/20mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/20mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/20mL |
| TRIPROLIDINE HYDROCHLORIDE | 2.5 mg/20mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
| YAN7R5L890 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2173662 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0a48f650-ad2a-4105-9ff4-2bc4d94b46d3 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-8078-45 | Cold and FluDaytime Nighttime Severe | 177 mL in 1 BOTTLE, PLASTIC | SOLUTION | 177 mL | 650 mg in 20mL | 3 |
| 0363-8078-45 | Cold and FluSevere | 177 mL in 1 BOTTLE, PLASTIC | SOLUTION | 177 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0363-8078 | COLD AND FLU DAYTIME NIGHTTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL) KIT [WALGREEN COMPANY] | 2 | Current NDC | 20241027_afbe932c-c26a-4fac-9ea3-d050db01eded.zip |
| 0363-8078 | COLD AND FLU SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL) SOLUTION [WALGREEN COMPANY] | 2 | Current NDC, 1 package rows | 20241012_0a48f650-ad2a-4105-9ff4-2bc4d94b46d3.zip |
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 |
|---|---|---|---|---|---|---|
| Family Care Saline | SODIUM CHLORIDE | United Exchange Corp. | 06737393-d4ae-3e7b-e063-6394a90ac19f | 2025-10-31 | Warnings | M012 |
| QUALITY CHOICE Maximum Strength Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association, Inc. | 40416ff5-06e1-97dd-e063-6394a90a2046 | 2025-10-30 | Warnings | M012 |
| Robitussin Maximum Strength Nighttime Cough DM | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | 44feee2f-25bc-48d4-8e13-db1d9daaaa90 | 2025-10-30 | Warnings | M012 |
| Robitussin Day and Night Cough Relief DM Max | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | b3d02c91-8f79-4eb4-a378-1072474c572c | 2025-10-30 | Warnings | M012 |
| ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | f1d022dd-c2ca-497f-87d5-9ef3e20e8ea7 | 2025-10-30 | Warnings | M012 |
| Endal | TRIPROLIDINE HCL, DEXTROMETHORPHAN HBR | Poly Pharmaceuticals, Inc. | fc5401e2-ed65-72e7-e053-6294a90a81f3 | 2025-10-30 | Warnings | M012 |
| daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Publix Super Markets Inc | c7cef266-46fc-49ab-a2e7-54fc56298659 | 2025-10-30 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | SAM'S WEST INC | 16592ad7-b7cb-0837-e063-6394a90ae059 | 2025-10-29 | Warnings | M012 |
| Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCL | SAFEWAY | 013b94a1-26c7-4371-981a-d1b9d7fd1c98 | 2025-10-29 | Warnings | M012 |
| Better Living | PHENYLEPHRINE HYDROCHLORIDE | BETTER LIVING BRANDS LLC | aea0db7f-e01a-4d8e-9c20-4a5ef4a905d1 | 2025-10-29 | Warnings | M012 |
| AXIM DayTime - Night Time 72 Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | VIVUNT PHARMA LLC | de9eb2d5-ba51-4637-e053-2995a90a0451 | 2025-10-29 | Warnings | M012 |
| Dollar General Vapor Steam | CAMPHOR (SYNTHETIC) | DOLGENCORP, LLC | 86d0f3ac-1359-c2f9-e053-2a91aa0a35d0 | 2025-10-29 | Warnings | M012 |
| Maximum Strength Mucus Relief DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Wal-Mart Stores,Inc., | a748d5ab-901c-47bb-8437-997542ecebfe | 2025-10-28 | Warnings | M012 |
| Nighttime Childrens Multi Symptoms Cold and Cough Multi-Symptom Relief | CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE | WAL-MART STORES,INC. | 68a68574-0fcb-4569-be57-d9aee5f62bea | 2025-10-28 | Warnings | M012 |
| Maximum Strength Mucus Relief Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores,Inc., | 635009a1-6154-4c62-a4be-d4f32c2cef8d | 2025-10-28 | Warnings | M012 |
| Family Care Nasal Relief | OXYMETAZOLINE HYDROCHLORIDE | United Exchange Corp | 6d0f8e9e-0503-522b-e053-2a91aa0aca35 | 2025-10-28 | Warnings | M012 |
| Family Care Nasal Relief | OXYMETAZOLINE HYDROCHLORIDE | United Exchange Corp | 6d0eef2f-f546-d769-e053-2991aa0a8fe4 | 2025-10-28 | Warnings | M012 |
| Tussin DM Cough and Chest Congestion Adult | DEXTROMETHORPHAN HBR, GUAIFENESIN | P & L Development, LLC | 4af67ba7-8892-442c-b9fb-80aba9140e05 | 2025-10-28 | Warnings | M012 |
| No Drip Nasal Mist Nasal Decongestant Severe Congestion | OXYMETAZOLINE HYDROCHLORIDE | Wal-Mart Stores,Inc., | 994fa270-65bb-4097-b88a-d5ce3c0e1c79 | 2025-10-27 | Warnings | M012 |
| Dye Free Childrens Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | WAL-MART STORES INC. | 3652ee94-b762-4100-a305-5acbec5f795a | 2025-10-27 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2637727 | {1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution) } Pack | GPCK | afbe932c-c26a-4fac-9ea3-d050db01eded | 3 |
| 2637727 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG in 10 mL Oral Solution) Pack | PSN | afbe932c-c26a-4fac-9ea3-d050db01eded | 3 |
| 1116572 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | afbe932c-c26a-4fac-9ea3-d050db01eded | 3 |
| 2173662 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution | PSN | 0a48f650-ad2a-4105-9ff4-2bc4d94b46d3 | 3 |
| 2173662 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution | PSN | afbe932c-c26a-4fac-9ea3-d050db01eded | 3 |
| 1116572 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | afbe932c-c26a-4fac-9ea3-d050db01eded | 3 |
| 2173662 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution | SCD | 0a48f650-ad2a-4105-9ff4-2bc4d94b46d3 | 3 |
| 2173662 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution | SCD | afbe932c-c26a-4fac-9ea3-d050db01eded | 3 |
| 2637727 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG / triprolidine HCl 1.25 MG per 10 ML Oral Solution) Pack | SY | afbe932c-c26a-4fac-9ea3-d050db01eded | 3 |
| 1116572 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | afbe932c-c26a-4fac-9ea3-d050db01eded | 3 |
| 2173662 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG per 10 mL Oral Solution | SY | afbe932c-c26a-4fac-9ea3-d050db01eded | 3 |
| 2173662 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG per 10 mL Oral Solution | SY | 0a48f650-ad2a-4105-9ff4-2bc4d94b46d3 | 3 |
| 1116572 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution | SY | afbe932c-c26a-4fac-9ea3-d050db01eded | 3 |
| 2173662 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral Solution | SY | afbe932c-c26a-4fac-9ea3-d050db01eded | 3 |
| 2173662 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral Solution | SY | 0a48f650-ad2a-4105-9ff4-2bc4d94b46d3 | 3 |
| 1116572 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | afbe932c-c26a-4fac-9ea3-d050db01eded | 3 |
| 2173662 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral Solution | SY | afbe932c-c26a-4fac-9ea3-d050db01eded | 3 |
| 2173662 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral Solution | SY | 0a48f650-ad2a-4105-9ff4-2bc4d94b46d3 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0363-8078-45 | 00363807845 | 177 mL in 1 BOTTLE, PLASTIC (0363-8078-45) | 177 ml | 2023-10-21 | No | No | Current |