Mucinex Fast-Max
- Product NDC
- 63824-015
- 11-digit product format
- 638240015
- Labeler code
- 63824
- Product ID
- 63824-015_5dcca751-b616-dd80-e063-6394a90a795d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Reckitt Benckiser LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-02-07
- 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
- Mucinex Fast-Max
- Brand name suffix
- Cold, Flu and Sore Throat
- 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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63824-015-66 | Mucinex Fast-MaxCold, Flu and Sore Throat | 180 mL in 1 BOTTLE | SOLUTION | 180 | 12 | |
| 63824-015-69 | Mucinex Fast-MaxCold, Flu and Sore Throat | 266 mL in 1 BOTTLE | SOLUTION | 266 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-015-66 | ML - Milliliter | 63824-015 | 9e1d0fea-96e4-4abe-be6b-7a79cd90af7e | 1 | 2012-07-24 |
| 63824-015-69 | ML - Milliliter | 63824-015 | 43719413-5127-43ea-a198-470846792c69 | 1 | 2013-09-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63824-015 | MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RB HEALTH (US) LLC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20241222_c902b4fc-c71c-4ef2-b5cb-6c2bd019acbc.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 |
|---|---|---|---|---|---|---|
| Mucus Relief DM | DEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MG | Pioneer Life Sciences, LLC | 3ce0f096-906e-47eb-8061-0ac1e9d8ea55 | 2025-12-26 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 1194c338-e115-4105-93d8-9ab833c43193 | 2025-12-26 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 9c9e558d-d991-4a2e-aa13-37c0b08071e6 | 2025-12-26 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 1695e7ea-2f83-4d3a-980e-c91be6c1f2a5 | 2025-12-25 | Warnings | M012 |
| GUAIFENESIN | GUAIFENESIN | Pharbest Pharmaceuticals, Inc. | 0bf70fb4-d3c8-476d-b864-4eadc697a7d8 | 2025-12-24 | Warnings | M012 |
| PHARBINEX-DM | GUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MG | Pharbest Pharmaceuticals, Inc. | 8d71db43-da87-45ee-aa4a-7e870bc5016d | 2025-12-24 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Safeway, Inc. | 764bcc58-bc5f-4ee6-82b7-cb0ed5baf3be | 2025-12-23 | Warnings | M012 |
| Tussin | GUAIFENESIN | Discount Drug Mart | 14de3d6d-4eb0-42cf-8941-cb42b3dd5c71 | 2025-12-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Pioneer Life Sciences, LLC | c8dcba06-a461-4af5-a120-666a63f06ac4 | 2025-12-23 | Warnings | M012 |
| SAFETUSSIN MAX STRENGTH MS Cough, Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN | KRAMER LABORATORIES | 920bde5f-4079-45de-aa59-24b00e50cb56 | 2025-12-23 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd | 46996bbf-948c-0aba-e063-6394a90a09e3 | 2025-12-23 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Lil' Drug Store Products, Inc. | 1d2e2a5a-099b-41b3-82bd-5bf704377f78 | 2025-12-23 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | 5b493ed7-9044-4841-9935-236d0bdc71a9 | 2025-12-23 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | 77a7ff9a-a414-4053-8d8d-369907d4380d | 2025-12-23 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Lil' Drug Store Products, Inc. | 8f320235-f243-4211-b99c-18526e686548 | 2025-12-23 | Warnings | M012 |
| Circle K Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | b6a46498-d9a8-4da2-9283-57d135f305a5 | 2025-12-23 | Warnings | M012 |
| Circle K Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Lil' Drug Store Products, Inc. | 7c5faec2-28c6-4c15-a268-d8b578140b74 | 2025-12-23 | Warnings | M012 |
| Sugar Free Honey Lemon Cough Drops | MENTHOL | Walmart | 67650b94-adbb-87fb-e053-2a91aa0a87e6 | 2025-12-23 | Warnings | M012 |
| Equate Benz-Dex Cough and Throat Lozenges | BENZOCAINE | Walmart | c0a6cb7f-a247-e610-e053-2a95a90a4199 | 2025-12-23 | Warnings | M012 |
| Equate Honey Lemon Cough Drops | MENTHOL | WalMart | 0028be18-5162-ff51-e063-6294a90ae517 | 2025-12-23 | 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 | c902b4fc-c71c-4ef2-b5cb-6c2bd019acbc | 12 |
| 1116572 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | c902b4fc-c71c-4ef2-b5cb-6c2bd019acbc | 12 |
| 1116572 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | c902b4fc-c71c-4ef2-b5cb-6c2bd019acbc | 12 |
| 1116572 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution | SY | c902b4fc-c71c-4ef2-b5cb-6c2bd019acbc | 12 |
| 1116572 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | c902b4fc-c71c-4ef2-b5cb-6c2bd019acbc | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63824-015-66 | 63824001566 | 180 mL in 1 BOTTLE (63824-015-66) | 180 ml | 2012-02-07 | 0000-00-00 | No | No | Current |
| 63824-015-69 | 63824001569 | 266 mL in 1 BOTTLE (63824-015-69) | 266 ml | 2012-02-07 | 0000-00-00 | No | No | Current |