Maximum Strength Mucinex Fast-Max Cold and Flu
- Product NDC
- 63824-548
- 11-digit product format
- 638240548
- Labeler code
- 63824
- Product ID
- 63824-548_51a46827-4e7d-7b1e-e063-6394a90a48c2
- 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 |
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 |
|---|---|
| 182222b5-a852-4dbe-b05f-a41d89806021 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Dollar General | NASAL PHENYLEPHRINE HYDROCHLORIDE | DOLGENCORP, INC. (DOLLAR GENERAL & REXALL) | e8fd3f0e-a023-4423-8906-17ae02bc083b | 2026-09-03 | Warnings | M012 |
| Mucus Relief Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI | TARGET Corporation | 1bf9a59e-cc37-4780-ba75-7138c546eb19 | 2026-09-02 | Warnings | M012 |
| Childrens Multi Symptom Fever and Cold | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | THE KROGER CO. | 3daf7620-eb57-43d5-ba88-938b7221e346 | 2026-09-02 | Warnings | M012 |
| PHENAGIL | PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE | Gil Pharmaceutical Corp | 69fd13a1-2b76-8574-e053-2a91aa0a27e7 | 2026-09-02 | Warnings | M012 |
| PHENAGIL | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL | Gil Pharmaceutical Corp. | a6880389-0dc1-43a7-a73b-77f77bafe51e | 2026-09-02 | Warnings | M012 |
| PHENAGIL | PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE | Gil Pharmaceutical Corp | fa8510d8-d50a-4743-ba87-a12e9ab43125 | 2026-09-02 | Warnings | M012 |
| PHENAGIL | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL | Gil Pharmaceutical Corp | dfcf1231-8271-458d-b375-e328d6fd4e9b | 2026-09-02 | Warnings | M012 |
| Nighttime Cold and Flu Multi Symptom Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Shield Pharmaceuticals Corp | decafa3a-3734-4161-bab0-121945881846 | 2026-09-02 | Warnings | M012 |
| Kroger Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCL | KROGER COMPANY | 1ff037ea-1a3b-430a-be31-2e240cc3b6f3 | 2026-09-02 | Warnings | M012 |
| KROGER Mucus Relief DM Maximum Strength | DEXTROMETHORPHAN HBR AND GUAIFENESIN | KROGER COMPANY | 79d24014-1af7-4d62-bcb8-5bea76a7d6ee | 2026-09-02 | Warnings | M012 |
| Kroger No Drip | ALLERGY SINUS | KROGER COMPANY | 4788bafb-8866-4a0a-b217-226513799c24 | 2026-09-02 | Warnings | M012 |
| Maximum Strength Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | KROGER COMPANY | e1d27123-358f-4b0c-8e3b-33474750a0e6 | 2026-09-02 | Warnings | M012 |
| Maximum Strength Nighttime Cold and Flu | ACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCL | THE KROGER CO | 058b2021-8a61-40b0-8a2e-a784d2b847fb | 2026-09-02 | Warnings | M012 |
| KROGER Dye Free Childrens Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | KROGER COMPANY | 2bea22e9-34b6-4961-94bb-5600dd90e891 | 2026-09-02 | Warnings | M012 |
| KROGER No Drip Nasal Mist Severe Congestion | OXYMETAZOLINE HYDROCHLORIDE | KROGER COMPANY | 7256e048-ad69-4322-844d-872f05e6fc8a | 2026-09-02 | Warnings | M012 |
| Daytime Cold and Flu Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL | The Kroger Co. | 494e69ef-dc9f-4e14-b856-5eaf0f541a03 | 2026-09-02 | Warnings | M012 |
| MAX Tussin Cough and Chest Congestion DM Sugar Free | DEXTROMETHORPHAN HBR, GUAIFENESIN | Akron Pharma Inc. | 5c4c8115-cec9-4f2c-9ea9-328535e97b07 | 2026-09-01 | Warnings | M012 |
| MAX ALLERGY KIDS | DIPHENHYDRAMINE HCL | Akron Pharma Inc. | 96c4ade8-67b1-41e5-8624-fb49090208af | 2026-09-01 | Warnings | M012 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE | HEXYLRESORCINOL AND MENTHOL | Reckitt Benckiser LLC | 4a938e15-a996-8538-e063-6294a90ad4ee | 2026-09-01 | Warnings | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | WALMART INC. | 5e6623c3-6210-4c50-94d6-5554f36876d1 | 2026-08-31 | 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 |