Mucinex Fast-Max
- Product NDC
- 63824-540
- 11-digit product format
- 638240540
- Labeler code
- 63824
- Product ID
- 63824-540_5dcf1519-2c79-ee19-e063-6394a90aaadb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Reckitt Benckiser LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-11-01
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 20; 400; 10 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
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 | 63824-540 | 63824-540-81 | 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 | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63824-540-81 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63824-540-81 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63824-540-81 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63824-540-81 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63824-540-81 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63824-540-81 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63824-540-81 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63824-540-81 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63824-540-81 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 63824-540-81 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 63824-540-81 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 63824-540-81 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 63824-540-66 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 63824-540-69 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 63824-540-81 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 63824-540-66 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 63824-540-69 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
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
- Severe Congestion and Cough
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/20mL |
| GUAIFENESIN | 400 mg/20mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/20mL |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63824-540-66 | Mucinex Fast-MaxSevere Congestion and Cough | 180 mL in 1 BOTTLE | SOLUTION | 180 | 10 | |
| 63824-540-69 | Mucinex Fast-MaxSevere Congestion and Cough | 266 mL in 1 BOTTLE | SOLUTION | 266 | 10 | |
| 63824-540-81 | Mucinex Fast-MaxSevere Congestion and Cough | 2 in 1 CELLO PACK | SOLUTION | 2 | 10 | |
| 63824-540-66 | Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nighttime Cold and Flu | 180 mL in 1 BOTTLE | SOLUTION | 180 mL | 20 mg in 20mL | 6 |
| 63824-540-66 | Mucinex Fast-Max Severe Congestion and Cough 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 |
|---|---|---|---|---|---|
| 63824-540-66 | ML - Milliliter | 63824-540 | f7218095-11c4-4af3-b74a-45d57a17d90f | 1 | 2019-02-13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63824-540 | MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RB HEALTH (US) LLC] | 8 | Current NDC, Legacy NDC, 3 package rows | 20240124_a25278bd-c3b9-4db3-b4f7-b395eb5f9177.zip |
| 63824-540 | MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH AND MUCINEX NIGHTSHIFT COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) KIT [RB HEALTH (US) LLC] | 4 | Current NDC, Legacy NDC | 20241222_4592d547-556f-4eec-8faf-6ff9a92e46c8.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 |
|---|---|---|---|---|---|---|
| Thompson Cherry Cough Drops | MENTHOL | Thompson Safety LLC | c948f5b0-8491-6f9f-e053-2995a90a55fa | 2025-09-08 | Warnings | M012 |
| Medique Decorel Forte | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | e64c283b-0efa-0bfd-e053-2a95a90ab71d | 2025-09-08 | Warnings | M012 |
| Daytime Nighttime Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE | Walgreens | a99fdd49-0160-4a82-983b-fa56ab38ae76 | 2025-09-08 | Warnings | M012 |
| Dye Free Wal Dryl Allergy childrens | DIPHENHYDRAMINE HYDROCHLORIDE | Walgreens | 53e6f72d-15a4-4efe-8b1f-5753fed53df8 | 2025-09-08 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreens | 40bfd631-51a4-4684-9ba0-a365d61da9bc | 2025-09-08 | Warnings | M012 |
| Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Walgreens | f796ce1f-3077-4a0d-a41a-249c345ddb5f | 2025-09-08 | Warnings | M012 |
| equate nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Wal-Mart Stores Inc | 6ccbd537-2264-4b3c-804e-3d3ea5368a5f | 2025-09-05 | Warnings | M012 |
| Ephedrine Sulfate | EPHEDRINE SULFATE | Walgreen Company | dc0072f9-7111-1af0-e053-2a95a90aed56 | 2025-09-04 | Warnings | M012 |
| Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | CVS Pharmacy, Inc | 31aa77e0-cfdb-57a8-e063-6394a90af98c | 2025-09-04 | Warnings | M012 |
| Effervescent Orange Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | CVS Pharmacy, Inc. | 4bb70a55-de44-3dc1-e054-00144ff8d46c | 2025-09-04 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3de637b1-3402-db86-e063-6294a90ac981 | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C | Medical Group Care LLC | f4a9cfec-0725-8f4a-e053-2995a90a1b4a | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3de65c99-6c2d-3650-e063-6394a90aa98c | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREE | Medical Group Care LLC | f4a9d879-4736-4f63-e053-2995a90adeba | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3de66240-441c-00ad-e063-6294a90a4a05 | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C | Medical Group Care LLC | ff99c57a-e06a-69d3-e053-6394a90a6775 | 2025-09-03 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS VITAMIN C SUGAR-FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3de7ace0-e389-b751-e063-6394a90ab4e9 | 2025-09-03 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS VITAMIN C SUGAR-FREE | DISCOUNT DRUG MART | 06673358-1afc-4d75-e063-6394a90a6ab1 | 2025-09-03 | Warnings | M012 |
| ValuMeds Cough Relief, Dextromethorphan Hbr | DEXTROMETHORPHAN HYDROBROMIDE | Cabinet Health P.B.C. | b16a81db-d9bc-4cce-8ec2-dc189184931e | 2025-09-03 | Warnings | M012 |
| topcare day time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 256d96f0-67bf-42d2-85ef-f49625c5910f | 2025-09-02 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1043543 | dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | a25278bd-c3b9-4db3-b4f7-b395eb5f9177 | 10 |
| 1043543 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | a25278bd-c3b9-4db3-b4f7-b395eb5f9177 | 10 |
| 1043543 | dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | a25278bd-c3b9-4db3-b4f7-b395eb5f9177 | 10 |
| 1043543 | dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution | SY | a25278bd-c3b9-4db3-b4f7-b395eb5f9177 | 10 |
| 2390630 | {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 / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } Pack | GPCK | 3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc | 6 |
| 2390630 | 1 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 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 | 3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc | 6 |
| 2173667 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution | PSN | 3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc | 6 |
| 1043543 | dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | 3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc | 6 |
| 2173667 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution | SCD | 3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc | 6 |
| 1043543 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc | 6 |
| 2390630 | 1 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 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 | 3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc | 6 |
| 2173667 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral Solution | SY | 3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc | 6 |
| 2173667 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral Solution | SY | 3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc | 6 |
| 1043543 | dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc | 6 |
| 1043543 | dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution | SY | 3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc | 6 |
| 2390630 | {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 / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } Pack | GPCK | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 5 |
| 2390630 | 1 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 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 | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 5 |
| 2173667 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution | PSN | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 5 |
| 1043543 | dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 5 |
| 2173667 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution | SCD | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 5 |
| 1043543 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 5 |
| 2390630 | 1 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 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 | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 5 |
| 2173667 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral Solution | SY | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 5 |
| 2173667 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral Solution | SY | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 5 |
| 1043543 | dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 5 |
| 1043543 | dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution | SY | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63824-540-66 | 63824054066 | 180 mL in 1 BOTTLE (63824-540-66) | 180 ml | 2017-11-01 | 0000-00-00 | No | No | Current |
| 63824-540-69 | 63824054069 | 266 mL in 1 BOTTLE (63824-540-69) | 266 ml | 2017-11-01 | 0000-00-00 | No | No | Current |
| 63824-540-81 | 63824054081 | 2 BOTTLE in 1 CELLO PACK (63824-540-81) > 266 mL in 1 BOTTLE (63824-540-69) | 2 bottle | 2018-10-01 | 0000-00-00 | No | No | Current |