Cold and Flu
- Product NDC
- 0363-9042
- 11-digit product format
- 003639042
- Labeler code
- 0363
- Product ID
- 0363-9042_e44f4a37-b47b-4505-a2ff-9c6aa348efdd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine 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; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL
- 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
- Cold and Flu
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/20mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/20mL |
| GUAIFENESIN | 400 mg/20mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/20mL |
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 |
|---|---|
| 1116572 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 84202ebe-97b6-4be2-bb09-7f2729303f96 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-9042-45 | Cold and Flu | 177 mL in 1 BOTTLE, PLASTIC | SOLUTION | 177 | 3 | |
| 0363-9042-45 | Cold and FluDaytime Nighttime Severe | 177 mL in 1 BOTTLE, PLASTIC | SOLUTION | 177 mL | 400 mg in 20mL | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0363-9042 | COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [WALGREEN COMPANY] | 2 | Current NDC, 1 package rows | 20241012_84202ebe-97b6-4be2-bb09-7f2729303f96.zip |
| 0363-9042 | 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 |
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 Wellness Effervescent Cold Relief Orange | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Family Dollar Services, Inc. | 4e13511b-fbb5-2523-e054-00144ff88e88 | 2024-07-03 | Warnings | M012 |
| Nighttime Cherry Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | TARGET CORPORATION | 1c3f6cbf-a00d-45b9-e063-6394a90a797c | 2024-07-02 | Warnings | M012 |
| Cold Terminator Cold Relief | PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Wildman Business Group | e8538d9c-f9ba-40b1-b60f-f57921f39b64 | 2024-07-01 | Warnings | M012 |
| Nighttime Severe Honey Cold and Flu | ACETAMINOPHEN, DEXTROMETHROPHAN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORPORATION | 1c02e465-8750-a088-e063-6394a90a8efb | 2024-06-29 | Warnings | M012 |
| ACTIDOM DMX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | ACTIPHARMA, LLC | 0166322e-7dbb-4658-a5c5-1d0525bb7655 | 2024-06-28 | Warnings | M012 |
| ACTINEL DM | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | ACTIPHARMA, LLC | 16660d82-524b-42ca-8581-48237caa13b2 | 2024-06-28 | Warnings | M012 |
| PurgenLabs Acetaminophen | ACTAMINOPHEN | Advanced Rx LLC | 915c4608-af1b-4119-8291-4ce9fd701d76 | 2024-06-28 | Warnings | M012 |
| Daytime Ultra Concentrated Cold and Flu | ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL | TARGET CORPORATION | 1bc90b2f-612c-e977-e063-6294a90a40b4 | 2024-06-26 | Warnings | M012 |
| Halls Mentholyptus | MENTHOL | Mondelez Global LLC | f5292c5b-5608-4e13-afc2-4f3d7133da88 | 2024-06-25 | Warnings | M012 |
| Halls Strawberry | MENTHOL | Mondelez Global LLC | 75638f29-7f2a-46b0-b8a0-e87bc7d6eba1 | 2024-06-25 | Warnings | M012 |
| Good Sense Nasal Decongestant PE | PHENYLEPHRINE HYDROCHLORIDE | A-S Medication Solutions | 5396a9cf-16eb-4628-9432-f49c67ffe2ce | 2024-06-25 | Warnings | M012 |
| Nighttime Cold and Flu Liquid | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 130ca5f1-2951-ec6f-e063-6394a90a754f | 2024-06-24 | Warnings | M012 |
| Daytime and Nighttime Severe Honey Cold and Flu | DAYTIME - ACETAMINOPHEN. DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND NIGHTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 08fd1513-30ab-15da-e063-6394a90ab57d | 2024-06-21 | Warnings | M012 |
| Daytime Severe and Nighttime Severe cold and flu | DAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORPORATION | 0c0caa59-0637-bc33-e063-6294a90ae244 | 2024-06-21 | Warnings | M012 |
| Halls Strawberry | MENTHOL | Mondelez Global LLC | de401eb4-3282-4298-8a51-15d268253464 | 2024-06-21 | Warnings | M012 |
| Cough and Chest Congestion DM Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | Walgreens | e4515d0e-c12b-40cd-8218-6d91476cfebd | 2024-06-21 | Warnings | M012 |
| SUDOGEST | PSEUDOEPHEDRINE HCL | A-S Medication Solutions | 1811199f-bf88-475f-8f94-b372db4bead3 | 2024-06-20 | Warnings | M012 |
| Theraflu Severe Cold Relief Soft Chews | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 91dbb541-6a86-4803-a1fe-1bf61b457c34 | 2024-06-19 | Warnings | M012 |
| Tukol Max Action Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | aedce1f9-4902-4c51-92e0-6056196394c2 | 2024-06-14 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | dbc71f58-0704-4d2b-aed1-0dc01f980006 | 2024-06-11 | 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 | 84202ebe-97b6-4be2-bb09-7f2729303f96 | 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 | 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 | 84202ebe-97b6-4be2-bb09-7f2729303f96 | 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 | 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 | 84202ebe-97b6-4be2-bb09-7f2729303f96 | 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 |
| 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 |
| 1116572 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution | SY | 84202ebe-97b6-4be2-bb09-7f2729303f96 | 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 |
| 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 |
| 1116572 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 84202ebe-97b6-4be2-bb09-7f2729303f96 | 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0363-9042-45 | 00363904245 | 177 mL in 1 BOTTLE, PLASTIC (0363-9042-45) | 177 ml | 2023-10-21 | No | No | Current |