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 | 2026-10-27 |
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 |
|---|---|---|---|---|---|---|
| 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 |
| Cough Drops Honey Lemon with Sugar | MENTHOL | Lidl US LLC | 4ad9398f-7488-6eaf-e054-00144ff8d46c | 2024-11-05 | Warnings | M012 |
| rexall dm cough and congestion relief | DEXTROMETHORPHAN HBR, GUAIFENESIN | Dolgencorp, LLC | 906838b1-a742-4728-944d-42b687b8cd59 | 2024-11-05 | Warnings | M012 |
| tussin | DEXTROMETHORPHAN HBR, GUAIFENESIN | H E B | 7c24c59c-7549-4c64-95f8-4bf755cd6f61 | 2024-11-05 | Warnings | M012 |
| equate adult tussin dm max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Wal-Mart Stores Inc | 3592e000-a6c6-47fe-8bb0-9341c65c2959 | 2024-11-05 | Warnings | M012 |
| tussin dm max | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Walgreen Company | 756794b0-8d3b-4732-947c-a407caf400e2 | 2024-11-05 | Warnings | M012 |
| basic care tussin dm max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Amazon.com Services LLC | c6863e31-e1b9-40ff-ae2e-4aec86b4acc0 | 2024-11-05 | Warnings | M012 |
| topcare tussin dm max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Topco Associates LLC | 94c35025-7bb4-4cb0-8bf3-4b44bb7fa59a | 2024-11-05 | Warnings | M012 |
| Childrens Sudafed PE NASAL DECONGESTANT | PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d | 2024-11-04 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Safeway, Inc. | 164b2559-2d3f-431e-a03c-07e86731af5c | 2024-11-04 | Warnings | M012 |
| tussin severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | H E B | 7cc2c136-d1b7-4658-99bb-73bb1d140261 | 2024-11-04 | Warnings | M012 |
| dg health tussin | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp Inc | a5d0ee70-d528-4a53-bf01-7bb13b364ed0 | 2024-11-04 | Warnings | M012 |
| basic care tussin cf severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | bba9a17d-eb87-46f3-acee-c9dd34e5bfd4 | 2024-11-04 | Warnings | M012 |
| topcare tussin cf max | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | b553b7e6-933b-49e3-97d3-22a4643a04b9 | 2024-11-04 | Warnings | M012 |
| dg health nasal original | OXYMETAZOLINE HYDROCHLORIDE | Dolgencorp, LLC | fb209752-705a-4bb0-9298-8b70357f3911 | 2024-11-02 | 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 |