Mucinex Fast-Max
- Product NDC
- 63824-019
- 11-digit product format
- 638240019
- Labeler code
- 63824
- Product ID
- 63824-019_5dcd1d5b-fde9-8065-e063-6294a90a1cea
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dextromethorphan hydrobromide and guaifenesin
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Reckitt Benckiser LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-07-18
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 20; 400 mg/20mL; mg/20mL
- Pharmacologic classes
- 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]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 63824-019 | 63824-019-22 | D | Discontinued by firm | 2026-10-21 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
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
- DM Max
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/20mL |
| GUAIFENESIN | 400 mg/20mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63824-019-22 | Mucinex Fast-MaxDM Max | 180 mL in 1 BOTTLE | SOLUTION | 180 | 13 | |
| 63824-019-22 | Mucinex Fast-MaxDM Max | 2 in 1 CARTON | SOLUTION | 2 | 13 | |
| 63824-019-66 | Mucinex Fast-MaxDM Max | 180 mL in 1 BOTTLE | SOLUTION | 180 | 13 | |
| 63824-019-66 | Mucinex Fast-Max DM Max and Mucinex Nighttime Cold and Flu | 180 mL in 1 BOTTLE | SOLUTION | 180 mL | 400 mg in 20mL | 6 |
| 63824-019-66 | Mucinex Fast-Max DM Max and Mucinex Nightshift Cold and Flu | 180 mL in 1 BOTTLE | SOLUTION | 180 mL | 400 mg in 20mL | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-019-66 | ML - Milliliter | 63824-019 | de56a7cd-8891-4cd0-ae71-eaa5dcedbeae | 1 | 2014-10-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63824-019 | MUCINEX FAST-MAX DM MAX (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RB HEALTH (US) LLC] | 11 | Current NDC, Legacy NDC, 3 package rows | 20241004_6a8cdcad-4881-49b8-a3f1-2c1574300d18.zip |
| 63824-019 | MUCINEX FAST-MAX DM MAX AND MUCINEX NIGHTSHIFT COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDE) KIT [RB HEALTH (US) LLC] | 4 | Current NDC, Legacy NDC | 20241222_2ed3c844-0532-40d9-beba-738d196de34d.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 |
|---|---|---|---|---|---|---|
| up and up Daytime Nighttime Childrens Multi Symptom Cold | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Target Corporation | b8a4da0b-e4d3-48e6-b699-cb56c7b67ed7 | 2025-11-20 | Warnings | M012 |
| Supress DX Pediatric Drops | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | KRAMER NOVIS | ddb95436-7806-4086-af4d-18a6625b5c83 | 2025-11-20 | Warnings | M012 |
| Cough Drops Gems Flawless Cherry Flavor 30ct | MENTHOL | Riclan S.A. | 0f0260df-89ac-4b83-afea-3aff56ff1b43 | 2025-11-18 | Warnings | M012 |
| Cough Drops Gems Flawless Honey Lemon Flavor 30ct | MENTHOL | Riclan S.A. | 16f6d531-9298-4172-8d08-ecd87d6add76 | 2025-11-18 | Warnings | M012 |
| Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Haleon US Holdings LLC | a6f750c8-8738-4965-a3ad-612c24611056 | 2025-11-18 | Warnings | M012 |
| YINCHIAO | ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE | ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD. | 09ba45f6-03e1-46b9-83ab-a618b2626716 | 2025-11-18 | Warnings | M012 |
| GANMAOLING | ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE | ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD. | c757a03e-59ea-469c-970d-4bc62e73f36f | 2025-11-18 | Warnings | M012 |
| M-Dryl | DIPHENHYDRAMINE HYDROCHLORIDE | Bryant Ranch Prepack | e1d545dc-9222-4d61-964d-1c781215d7d2 | 2025-11-18 | Warnings | M012 |
| Goodnow cold flu day relief cold flu night relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Gobrands, Inc | 7590d0c6-121e-4016-b6bb-534c5d0a7970 | 2025-11-17 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | R J General Corporation | d786ae07-ce57-44c7-9ba5-f4c87df115de | 2025-11-17 | Warnings | M012 |
| Benadryl Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | R J General Corporation | c46c01c0-29f4-400c-bef5-14b3eb944c51 | 2025-11-17 | Warnings | M012 |
| TYLENOL COLD AND FLU | ACETAMINPHEN | R J General Corporation | b618877b-9dbc-4ba2-be2c-bf1922c646cc | 2025-11-17 | Warnings | M012 |
| TYLENOL SINUS SEVERE | ACETAMINOPHEN | R J General Corporation | 2cbf7954-b28f-4d7b-b142-6c6c5c58b25d | 2025-11-17 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | R J General Corporation | 8f0e4876-6bf0-4f6d-9cf0-f2aef2682ffc | 2025-11-17 | Warnings | M012 |
| Quality Choice Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | QUALITY CHOICE (Chain Drug Marketing Association) | c0e3c959-bed6-2ce5-e053-2995a90a0be9 | 2025-11-17 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | c5ea5a7a-c806-e5e0-e053-2995a90a15e9 | 2025-11-17 | Warnings | M012 |
| Multi-Symptom Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 50f3157b-5788-4b63-835a-e60c8dc33df9 | 2025-11-17 | Warnings | M012 |
| Day and Night Sinus | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | a9d809f5-63a1-4f80-8b4d-33e8e052c7bd | 2025-11-15 | Warnings | M012 |
| Cold and Flu Day, Night | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreen Company | 937b481a-e0b7-4d34-a8a1-0bfb2b867c2b | 2025-11-15 | Warnings | M012 |
| Sinus Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | f701a6ae-200d-48dc-94e4-6bd3228f50d4 | 2025-11-15 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1020138 | dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution | PSN | 6a8cdcad-4881-49b8-a3f1-2c1574300d18 | 13 |
| 1020138 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 6a8cdcad-4881-49b8-a3f1-2c1574300d18 | 13 |
| 1020138 | dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution | SY | 6a8cdcad-4881-49b8-a3f1-2c1574300d18 | 13 |
| 1020138 | dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 6a8cdcad-4881-49b8-a3f1-2c1574300d18 | 13 |
| 2287760 | {1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) } Pack | GPCK | 3ba2cc08-acad-79a8-e063-6394a90af17f | 6 |
| 2287760 | 1 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution) Pack | PSN | 3ba2cc08-acad-79a8-e063-6394a90af17f | 6 |
| 2173667 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution | PSN | 3ba2cc08-acad-79a8-e063-6394a90af17f | 6 |
| 1020138 | dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution | PSN | 3ba2cc08-acad-79a8-e063-6394a90af17f | 6 |
| 2173667 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution | SCD | 3ba2cc08-acad-79a8-e063-6394a90af17f | 6 |
| 1020138 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 3ba2cc08-acad-79a8-e063-6394a90af17f | 6 |
| 2287760 | 1 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG per 20 ML Oral Solution) Pack | SY | 3ba2cc08-acad-79a8-e063-6394a90af17f | 6 |
| 2173667 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral Solution | SY | 3ba2cc08-acad-79a8-e063-6394a90af17f | 6 |
| 2173667 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral Solution | SY | 3ba2cc08-acad-79a8-e063-6394a90af17f | 6 |
| 1020138 | dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution | SY | 3ba2cc08-acad-79a8-e063-6394a90af17f | 6 |
| 1020138 | dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 3ba2cc08-acad-79a8-e063-6394a90af17f | 6 |
| 2287760 | {1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) } Pack | GPCK | 2ed3c844-0532-40d9-beba-738d196de34d | 5 |
| 2287760 | 1 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution) Pack | PSN | 2ed3c844-0532-40d9-beba-738d196de34d | 5 |
| 2173667 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution | PSN | 2ed3c844-0532-40d9-beba-738d196de34d | 5 |
| 1020138 | dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution | PSN | 2ed3c844-0532-40d9-beba-738d196de34d | 5 |
| 2173667 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution | SCD | 2ed3c844-0532-40d9-beba-738d196de34d | 5 |
| 1020138 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 2ed3c844-0532-40d9-beba-738d196de34d | 5 |
| 2287760 | 1 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG per 20 ML Oral Solution) Pack | SY | 2ed3c844-0532-40d9-beba-738d196de34d | 5 |
| 2173667 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral Solution | SY | 2ed3c844-0532-40d9-beba-738d196de34d | 5 |
| 2173667 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral Solution | SY | 2ed3c844-0532-40d9-beba-738d196de34d | 5 |
| 1020138 | dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution | SY | 2ed3c844-0532-40d9-beba-738d196de34d | 5 |
| 1020138 | dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 2ed3c844-0532-40d9-beba-738d196de34d | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63824-019-22 | 63824001922 | 2 BOTTLE in 1 CARTON (63824-019-22) > 180 mL in 1 BOTTLE | 2 bottle | 2020-07-01 | 0000-00-00 | No | No | Current |
| 63824-019-66 | 63824001966 | 180 mL in 1 BOTTLE (63824-019-66) | 180 ml | 2012-07-18 | 0000-00-00 | No | No | Current |