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 |
|---|---|---|---|---|---|---|
| Childrens TYLENOL COLD Plus FLU | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 8b516736-86ac-47cb-a0ec-038d4c3a0020 | 2024-11-07 | Warnings | M012 |
| Tylenol Cold plus Flu plus Cough Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | e85e5eb9-3ecf-4784-999e-111e38e306f5 | 2024-11-07 | Warnings | M012 |
| TYLENOL COLD PLUS FLU SEVERE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | ef8a846d-4b29-4fd8-a683-fada04d0a2b9 | 2024-11-07 | Warnings | M012 |
| Childrens TYLENOL COLD Plus FLU | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 9761c807-75a1-4498-a8c6-1f2b1c9ffde6 | 2024-11-07 | Warnings | M012 |
| TYLENOL Cold Plus Mucus Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 24ac94e8-b223-424e-bcd2-9c027c8ff9ed | 2024-11-07 | Warnings | M012 |
| Primatene | EPHEDRINE HYDROCHLORIDE | Foundation Consumer Brands | 2170f081-c03f-47e8-bc63-4052c5e653fa | 2024-11-07 | Warnings | M012 |
| Rompe Pecho Max Multi Symptoms | ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN | EFFICIENT LABORATORIES INC | 938e4e47-d2d9-4b0d-bf88-e9f41b501945 | 2024-11-07 | Warnings | M012 |
| topcare sinus nasal | OXYMETAZOLINE HYDROCHLORIDE | Topco Associates LLC | ca1fefed-e9d7-430a-9da4-972b1a6fb786 | 2024-11-07 | Warnings | M012 |
| Leader Daytime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Cardinal Health 110, LLC. dba Leader | dd82a389-9ec5-4b3f-a9ea-1a56871ebd17 | 2024-11-07 | Warnings | M012 |
| topcare day time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 1a8e2e03-e11b-4da1-945b-e2caadea7243 | 2024-11-07 | Warnings | M012 |
| SUDOGEST NASAL DECONGESTANT | PSEUDOEPHEDRINE HCL | A-S Medication Solutions | 09feb5f0-c22d-4a1b-97a0-d5767e5f7730 | 2024-11-07 | Warnings | M012 |
| up and up childrens allergy melts | DIPHENHYDRAMINE HCL | Target Corporation | f98d1d54-8e11-4bb1-825a-ab5447d37847 | 2024-11-07 | Warnings | M012 |
| good sense severe day time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | 44130a1b-63cc-42ac-9590-fdf21a12d164 | 2024-11-07 | Warnings | M012 |
| foster and thrive daytime severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Strategic Sourcing Services LLC | a5ff1134-8985-4585-8e61-a5fd5f60afeb | 2024-11-07 | Warnings | M012 |
| basic care daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 50528d29-ce8c-4efb-a86c-17246b017db0 | 2024-11-07 | Warnings | M012 |
| cooling severe daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS Pharmacy | d4a21760-b2bd-4e26-bff0-6fc1b05d26b3 | 2024-11-07 | Warnings | M012 |
| dg health day time severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, LLC | 60870311-3234-44ba-95dd-09cf4ea3d508 | 2024-11-07 | Warnings | M012 |
| adult dm max cough and chest congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Meijer Distribution Inc | 3a6855c1-da6d-4fa9-81fe-d2e61355989f | 2024-11-06 | Warnings | M012 |
| oxymetazoline hcl | OXYMETAZOLINE HYDROCHLORIDE | A-S Medication Solutions | e51dfb62-40d0-4bec-9574-90057cb35bcc | 2024-11-06 | Warnings | M012 |
| Foster and Thrive Adult Tussin DM MAX | DEXTROMETHORPHAN HBR, GUAIFENESIN | Strategic Sourcing Services LLC | 5f6e4d56-4a66-4dbd-97c8-550310dea358 | 2024-11-05 | 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 |