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 |
|---|---|---|---|---|---|---|
| NICE Honey Lemon Cough Drops | MENTHOL | Leosons Overseas Corp | 96da2c9d-2d0d-6252-e053-2995a90ac338 | 2024-11-19 | Warnings | M012 |
| SanaTos Boost | DEXTROMETHORPHAN HBR | Pharmadel LLC | ae6a424f-f3f0-3f6c-e053-2995a90a972d | 2024-11-18 | Warnings | M012 |
| SanaTos Turbo Max Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Pharmadel LLC | d56a071c-a747-5397-e053-2995a90aad8b | 2024-11-18 | Warnings | M012 |
| equaline childrens cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | a24021a0-ef68-4bce-ba53-d262d1025cc0 | 2024-11-17 | Warnings | M012 |
| Cold and Cough DM | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Publix Super Markets Inc | 4d5f93c1-7752-4948-ba58-c4385cfc24c8 | 2024-11-17 | Warnings | M012 |
| Good Sense Childrens Cold and Cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L. Perrigo Company | 8a87104f-94a4-4585-afd5-d610eea32e39 | 2024-11-17 | Warnings | M012 |
| equate childrens cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | c91e94f4-4c51-4fe7-ad2e-0b9dc58b51e4 | 2024-11-17 | Warnings | M012 |
| foster and thrive childrens allergy relief | DIPHENHYDRAMINE HYDROCHLORIDE | Strategic Sourcing Services LLC | 1eac715b-351c-4b47-8d1d-6e921813c1a4 | 2024-11-15 | Warnings | M012 |
| basic care daytime severe cold and flu nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | 298d2796-5ae5-4346-b6d2-2ced2dd29dc3 | 2024-11-15 | Warnings | M012 |
| dg health day time severe cold and flu relief night time severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Dolgencorp, LLC | f721b393-9ad5-4fc6-a2c5-bd89e58caf16 | 2024-11-15 | Warnings | M012 |
| basic care daytime severe cold and flu nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | 9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f2 | 2024-11-15 | Warnings | M012 |
| Rompe Pecho EX | GUAIFENESIN | Efficient Laboratories Inc | 89ea23a5-0da7-407e-83d9-77a0b562f3af | 2024-11-14 | Warnings | M012 |
| basic care daytime cold and flu nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Amazon.com Services LLC | ceb342da-ff6d-4c19-9f78-0033d028075e | 2024-11-14 | Warnings | M012 |
| Topcare Nite Time Day Time Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Topco Associates LLC | efb8e0e2-0795-4f4a-8ca6-955f33bee143 | 2024-11-14 | Warnings | M012 |
| good neighbor pharmacy nasal four | PHENYLEPHRINE HYDROCHLORIDE | Amerisource Bergen | a3d637dc-d957-458c-8a75-f948601a31aa | 2024-11-14 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | Meijer Distribution Inc | ec8db98f-4fd1-4644-b76f-ff04f72e87f4 | 2024-11-13 | Warnings | M012 |
| dg health tussin | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp, LLC | 6f9b8267-1e0b-430b-8e44-06408ae82ea4 | 2024-11-13 | Warnings | M012 |
| Walgreens Effervescent Cold Relief Plus | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Walgreens | b60e2cf9-11ec-469e-e053-2a95a90a712a | 2024-11-13 | Warnings | M012 |
| Kroger Effervescent Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Kroger Company | 69333774-3cf4-384d-e053-2a91aa0a48b3 | 2024-11-13 | Warnings | M012 |
| Effervescent Orange Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | H. E. Butt Grocery Company | 6403fe3d-d82b-f4d5-e053-2991aa0ac7d6 | 2024-11-13 | 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 |