Maximum Strength Mucinex Fast-Max Cold and Flu
- Product NDC
- 63824-548
- 11-digit product format
- 638240548
- Labeler code
- 63824
- Product ID
- 63824-548_5dc0f3a3-bd7f-1d1a-e063-6294a90a3902
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Reckitt Benckiser LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-07-28
- 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
- Maximum Strength Mucinex Fast-Max 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63824-548-33 | Maximum Strength Mucinex Fast-Max Cold and Flu | 180 mL in 1 BOTTLE | SOLUTION | 180 | 8 | |
| 63824-548-33 | Maximum Strength Mucinex Fast-Max Cold and Flu | 3 in 1 CARTON | SOLUTION | 3 | 8 | |
| 63824-548-64 | Maximum Strength Mucinex Fast-Max Cold and Flu | 118 mL in 1 BOTTLE | SOLUTION | 118 | 8 | |
| 63824-548-64 | Maximum Strength Mucinex Fast-Max Cold and Flu | 1 in 1 CARTON | SOLUTION | 1 | 8 | |
| 63824-548-66 | Maximum Strength Mucinex Fast-Max Cold and Flu | 180 mL in 1 BOTTLE | SOLUTION | 180 | 8 | |
| 63824-548-69 | Maximum Strength Mucinex Fast-Max Cold and Flu | 266 mL in 1 BOTTLE | SOLUTION | 266 | 8 | |
| 63824-548-66 | Mucinex Fast-Max Cold and Flu and Mucinex Nighttime Cold and Flu | 180 mL in 1 BOTTLE | SOLUTION | 180 mL | 400 mg in 20mL | 6 |
| 63824-548-66 | Maximum Strength Mucinex Fast-Max Cold and Flu and Mucinex NightShift Severe Cold and Flu | 180 mL in 1 BOTTLE | SOLUTION | 180 mL | 10 mg in 20mL | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-548-64 | ML - Milliliter | 63824-548 | 2da381e8-f444-40c1-99aa-d6d83c2fbeb5 | 1 | 2019-06-19 |
| 63824-548-66 | ML - Milliliter | 63824-548 | 95b1598b-2eac-40c3-bf73-ec601044a1bd | 1 | 2020-04-20 |
| 63824-548-69 | ML - Milliliter | 63824-548 | ca1d4b9b-a3f4-401c-9430-8aa016170387 | 1 | 2020-05-08 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63824-548 | MAXIMUM STRENGTH MUCINEX FAST-MAX COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RB HEALTH (US)] | 6 | Current NDC, Legacy NDC, 6 package rows | 20240608_182222b5-a852-4dbe-b05f-a41d89806021.zip |
| 63824-548 | MAXIMUM STRENGTH MUCINEX FAST-MAX COLD AND FLU AND MUCINEX NIGHTSHIFT SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) KIT [RB HEALTH (US) LLC] | 4 | Current NDC, Legacy NDC | 20241222_29571047-4c4b-44ca-8726-57c28308e8cf.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 |
|---|---|---|---|---|---|---|
| good sense night time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | 89dc1423-d097-47a8-9025-eab5381cca26 | 2024-11-11 | Warnings | M012 |
| basic care nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 10f9627b-edda-422a-b01f-7066f9c98335 | 2024-11-11 | Warnings | M012 |
| nighttime severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 17c3fe42-3c40-4405-80b7-b3f9e4aa8376 | 2024-11-11 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | H E B | 1dd36aa7-f085-4350-8cf2-f9fa29b583e4 | 2024-11-11 | Warnings | M012 |
| topcare nite time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | a7f9f1d0-7498-461c-b4e8-4c92cf3feae8 | 2024-11-11 | Warnings | M012 |
| nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Walgreen Company | bd079f5d-0a38-40e6-9661-e8236c88a24d | 2024-11-11 | Warnings | M012 |
| GUAIFENESIN DM | GUAIFENESIN AND DEXTROMETHORPHAN | PAI Holdings, LLC dba PAI Pharma | ff970fff-d1a3-4322-83b4-34e361431a1c | 2024-11-11 | Warnings | M012 |
| topcare tussin dm max | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | e1118592-30ac-4505-9f38-c6d395c4cf5b | 2024-11-11 | Warnings | M012 |
| basic care nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 624b8029-9fdb-4908-a13b-f9dd75030120 | 2024-11-11 | Warnings | M012 |
| Biofreeze Colorless | MENTHOL | A-S Medication Solutions | cc1cba14-da40-4d7d-b522-b5c648798e96 | 2024-11-11 | Warnings | M012 |
| foster and thrive nighttime severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Strategic Sourcing Services LLC | 298b7754-d0d8-496d-9949-4c346cb11e34 | 2024-11-11 | Warnings | M012 |
| leader tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Cardinal Health 110, LLC. dba Leader | b418c10c-528b-4395-944e-af959b639ec2 | 2024-11-10 | Warnings | M012 |
| equaline adult tussin | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | United Natural Foods, Inc. dba UNFI | f7c753f8-4b12-4797-a599-736d597bc1bc | 2024-11-10 | Warnings | M012 |
| foster and thrive adult tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Strategic Sourcing Services LLC | f8933226-fbc9-44e3-a90f-4e6c1dbdb7b7 | 2024-11-10 | Warnings | M012 |
| dg health adult tussin | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Dolgencorp Inc | 81f12484-ddf7-49c6-b530-3a81d62ab40d | 2024-11-10 | Warnings | M012 |
| careone tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Retail Business Services, LLC | 230fa1ea-ae7c-425e-8447-79a90c96ae9e | 2024-11-10 | Warnings | M012 |
| good sense tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | L. Perrigo Company | cb8a1d81-b1a3-4217-b157-9e5d398f202d | 2024-11-09 | Warnings | M012 |
| PhysiciansCare Allergy Antihistamine | DIPHENHYDRAMINE HYDROCHLORIDE | Acme United Corporation | 5e31b1ff-291f-7b8c-e053-2a91aa0aedbc | 2024-11-09 | Warnings | M012 |
| Duraflu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL | Poly Pharmaceuticals, Inc. | 55fffc1d-8449-4c28-a391-c6f60dd85622 | 2024-11-09 | Warnings | M012 |
| Poly-Vent IR | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Poly Pharmaceuticals, Inc. | ce0d8c45-446a-4df4-a36b-5000ba69d30d | 2024-11-09 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1116572 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | 182222b5-a852-4dbe-b05f-a41d89806021 | 8 |
| 1116572 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 182222b5-a852-4dbe-b05f-a41d89806021 | 8 |
| 1116572 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | 182222b5-a852-4dbe-b05f-a41d89806021 | 8 |
| 1116572 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution | SY | 182222b5-a852-4dbe-b05f-a41d89806021 | 8 |
| 1116572 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 182222b5-a852-4dbe-b05f-a41d89806021 | 8 |
| 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 | 3ba3548e-85e7-b4a6-e063-6394a90af84d | 6 |
| 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 | 3ba3548e-85e7-b4a6-e063-6394a90af84d | 6 |
| 1116572 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | 3ba3548e-85e7-b4a6-e063-6394a90af84d | 6 |
| 2173662 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution | PSN | 3ba3548e-85e7-b4a6-e063-6394a90af84d | 6 |
| 1116572 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 3ba3548e-85e7-b4a6-e063-6394a90af84d | 6 |
| 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 | 3ba3548e-85e7-b4a6-e063-6394a90af84d | 6 |
| 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 | 3ba3548e-85e7-b4a6-e063-6394a90af84d | 6 |
| 1116572 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | 3ba3548e-85e7-b4a6-e063-6394a90af84d | 6 |
| 2173662 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG per 10 mL Oral Solution | SY | 3ba3548e-85e7-b4a6-e063-6394a90af84d | 6 |
| 1116572 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution | SY | 3ba3548e-85e7-b4a6-e063-6394a90af84d | 6 |
| 2173662 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral Solution | SY | 3ba3548e-85e7-b4a6-e063-6394a90af84d | 6 |
| 1116572 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 3ba3548e-85e7-b4a6-e063-6394a90af84d | 6 |
| 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 | 3ba3548e-85e7-b4a6-e063-6394a90af84d | 6 |
| 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 | 29571047-4c4b-44ca-8726-57c28308e8cf | 5 |
| 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 | 29571047-4c4b-44ca-8726-57c28308e8cf | 5 |
| 1116572 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | 29571047-4c4b-44ca-8726-57c28308e8cf | 5 |
| 2173662 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution | PSN | 29571047-4c4b-44ca-8726-57c28308e8cf | 5 |
| 1116572 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 29571047-4c4b-44ca-8726-57c28308e8cf | 5 |
| 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 | 29571047-4c4b-44ca-8726-57c28308e8cf | 5 |
| 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 | 29571047-4c4b-44ca-8726-57c28308e8cf | 5 |
| 1116572 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | 29571047-4c4b-44ca-8726-57c28308e8cf | 5 |
| 2173662 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG / triprolidine hydrochloride 1.25 MG per 10 mL Oral Solution | SY | 29571047-4c4b-44ca-8726-57c28308e8cf | 5 |
| 1116572 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution | SY | 29571047-4c4b-44ca-8726-57c28308e8cf | 5 |
| 2173662 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral Solution | SY | 29571047-4c4b-44ca-8726-57c28308e8cf | 5 |
| 1116572 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 29571047-4c4b-44ca-8726-57c28308e8cf | 5 |
| 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 | 29571047-4c4b-44ca-8726-57c28308e8cf | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63824-548-33 | 63824054833 | 3 BOTTLE in 1 CARTON (63824-548-33) / 180 mL in 1 BOTTLE | 3 bottle | 2023-08-01 | No | No | Current | |
| 63824-548-64 | 63824054864 | 1 BOTTLE in 1 CARTON (63824-548-64) / 118 mL in 1 BOTTLE | 1 bottle | 2018-10-01 | 0000-00-00 | No | No | Current |
| 63824-548-66 | 63824054866 | 180 mL in 1 BOTTLE (63824-548-66) | 180 ml | 2018-07-28 | 0000-00-00 | No | No | Current |
| 63824-548-69 | 63824054869 | 266 mL in 1 BOTTLE (63824-548-69) | 266 ml | 2018-07-28 | 0000-00-00 | No | No | Current |