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 | 2026-10-21 |
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 | 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 |
|---|---|---|---|---|---|---|
| Amazon Basics Honey Lemon Cough Drops 30ct | MENTHOL | Amazon | 3e75838b-e1c9-2d42-e063-6294a90aab82 | 2026-02-01 | Warnings | M012 |
| cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | HyVee Inc | 5110526f-51fd-401e-ba52-520674d34f37 | 2026-02-01 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Amazon.com Service LLC | 673996ab-6e57-4feb-8af3-d8b474741a8d | 2026-01-30 | Warnings, Adverse reactions | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Strategic Sourcing Services, LLC | 1d6c23d7-d1dc-4cba-8600-5762c18a0e27 | 2026-01-29 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Belmora LLC | 3622e072-2784-c57e-e063-6394a90a8217 | 2026-01-29 | Warnings, Adverse reactions | M012 |
| Night Time Cold and Flu ReadyInCase | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | P & L Development, LLC | e7dd763b-3005-4723-933b-171eb772afee | 2026-01-29 | Warnings | M012 |
| Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR | Softgel Healthcare Pvt Ltd | 24bc9ae6-8e8f-c0a0-e063-6394a90a407f | 2026-01-28 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | Softgel Healthcare Private Limited | 229d1939-84a9-f18e-e063-6394a90aba30 | 2026-01-28 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 1fcbafaa-c871-db6d-e063-6394a90aab5e | 2026-01-28 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 1f7a6375-ab66-9782-e063-6394a90a99f3 | 2026-01-28 | Warnings | M012 |
| ONESSIP ADULT NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI | MEDWISE LIFESCIENCES INC. | 4970b8bc-3c7b-4b8a-e063-6294a90a7f1b | 2026-01-28 | Warnings | M012 |
| Daytime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR | Family Dollar (FAMILY WELLNESS) | fe3e74ba-31d9-4d50-ab61-ffb6aaa66085 | 2026-01-28 | Warnings | M012 |
| Leader Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Cardinal Health 110, LLC. dba Leader | 9b1a5dbe-39dd-4dbb-800c-0cef422ae7c5 | 2026-01-28 | Warnings | M012 |
| Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 93d5b1db-e9ad-4a6a-b869-fd0d1a11df02 | 2026-01-27 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Wal-Mart Stores Inc | 53a3e6a7-d625-4393-95eb-bb6f86e86cc1 | 2026-01-27 | Warnings | M012 |
| Dextromethorphan Hbr,Guaifenesin | DEXTROMETHORPHAN HBR,GUAIFENESIN | SOFTGEL HEALTHCARE PRIVATE LIMITED | 2fbbfc7c-81a9-b647-e063-6394a90a55ac | 2026-01-27 | Warnings | M012 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 32074a31-326b-4aaf-e063-6394a90a0d40 | 2026-01-27 | Warnings | M012 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 335b6ddd-fdc8-1120-e063-6394a90add41 | 2026-01-27 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 37e8ccd5-6be1-9aca-e063-6394a90a5263 | 2026-01-27 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 2f7f078e-de04-9d53-e063-6394a90a409f | 2026-01-27 | 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 |