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 |
|---|---|---|---|---|---|---|
| Cold Flu Severe Day Night | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Harris Teeter | 2924a691-b352-4263-b6ba-9ab97e95e2a5 | 2024-10-22 | Warnings | M012 |
| Mucus Relief Cold and Flu All in One | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HARRIS TEETER | b2091281-a64a-190a-e053-2995a90a890a | 2024-10-22 | Warnings | M012 |
| tussin | DEXTROMETHORPHAN HBR, GUAIFENESIN | Safeway | cf04bdf7-fed4-4f06-a193-f2e83fcc531c | 2024-10-22 | Warnings | M012 |
| Tukol Honey Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | c9572b16-8e28-4f98-bd87-8a07721a49c6 | 2024-10-21 | Warnings | M012 |
| Tukol Honey Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Genomma Lab USA | bf25f38e-3549-4f78-be90-46605b5f2c11 | 2024-10-21 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | HEB | b5a6719e-746b-58ec-e053-2a95a90af010 | 2024-10-21 | Warnings | M012 |
| Allergy Multi Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | a6cdc084-c23b-e733-e053-2995a90a3506 | 2024-10-21 | Warnings | M012 |
| Cold Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | ea39a67d-8a99-4f7c-9925-94b07d0b1092 | 2024-10-21 | Warnings | M012 |
| Head Congestion plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | eb7920a3-3c25-6aa1-e053-2995a90ac2b9 | 2024-10-21 | Warnings | M012 |
| Mucus Relief Sinus Severe Congestion Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | 9cbb3ab1-5f32-421e-9f28-d99be9447e9f | 2024-10-21 | Warnings | M012 |
| Head Congestion plus Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | eb791902-e2c3-5662-e053-2995a90a37fd | 2024-10-21 | Warnings | M012 |
| Cold Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | c3849b66-697f-4f6e-93ab-76de031b3c70 | 2024-10-21 | Warnings | M012 |
| Cold Flu Severe Day Night | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | ee1477ed-00c4-46ea-bc57-aef214076dc2 | 2024-10-21 | Warnings | M012 |
| DAYTIME SEVERE COLD AND FLU MAXIMUM STRENGTH | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | 774e8bee-1ab5-4587-82e4-31da8ec83544 | 2024-10-21 | Warnings | M012 |
| Mucus Relief Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | b1ba8ade-3441-f243-e053-2995a90a1230 | 2024-10-21 | Warnings | M012 |
| Mucus Relief Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | b1ba22ac-c38d-a42e-e053-2995a90a6900 | 2024-10-21 | Warnings | M012 |
| Diphenhydramine HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 25034563-6422-daf6-e063-6394a90af980 | 2024-10-21 | Warnings | M012 |
| Childrens Allergy Relief Dye Free | DIPHENHYDRAMINE HCL | CARDINAL HEALTH 110, LLC. DBA LEADER | 198add5f-20b7-75b0-e063-6394a90a6bd4 | 2024-10-21 | Warnings | M012 |
| Tukol Honey Children Cough and Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | dae33df8-2294-4242-a25b-2d89d1f63b23 | 2024-10-18 | Warnings | M012 |
| sinus pressure and pain pe | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | GOODSENSE | a7931e4c-8a5e-66e2-e053-2995a90af2a4 | 2024-10-18 | 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 |