Mucinex Fast-Max
- Product NDC
- 63824-193
- 11-digit product format
- 638240193
- Labeler code
- 63824
- Product ID
- 63824-193_51a49920-1f2b-2b23-e063-6294a90ace67
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Reckitt Benckiser LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-03-15
- Substance
- GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 200; 10; 5 mg/1; mg/1; mg/1
- 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 | 63824-193 | 63824-193-20 | D | Discontinued by firm | 2026-10-20 | |
| excluded package | package | 63824-193 | 63824-193-30 | D | Discontinued by firm | 2026-10-20 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 63824-193-20 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 63824-193-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 63824-193-20 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 63824-193-20 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 63824-193-20 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 63824-193-20 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 63824-193-20 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 63824-193-20 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 63824-193-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 63824-193-20 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 63824-193-20 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 63824-193-20 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 63824-193-20 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 |
|---|---|
| GUAIFENESIN | 200 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 495W7451VQ | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1372652 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3ff4c4ea-7628-4d2b-a6e9-d994c25baef4 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63824-193-20 | Mucinex Fast-MaxSevere Congestion and Cough | 10 in 1 BLISTER PACK | TABLET, COATED | 10 | 12 | |
| 63824-193-20 | Mucinex Fast-MaxSevere Congestion and Cough | 2 in 1 CARTON | TABLET, COATED | 2 | 12 | |
| 63824-193-21 | Mucinex Fast-MaxSevere Congestion and Cough | 2 in 1 CARTON | TABLET, COATED | 2 | 12 | |
| 63824-193-21 | Mucinex Fast-MaxSevere Congestion and Cough | 10 in 1 BLISTER PACK | TABLET, COATED | 10 | 12 | |
| 63824-193-30 | Mucinex Fast-MaxSevere Congestion and Cough | 3 in 1 CARTON | TABLET, COATED | 3 | 12 | |
| 63824-193-30 | Mucinex Fast-MaxSevere Congestion and Cough | 10 in 1 BLISTER PACK | TABLET, COATED | 10 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-193-20 | EA - Each | 63824-193 | ce7e2c2e-b0c4-44d2-9cf8-7f3b1991e1c3 | 1 | 2013-11-04 |
| 63824-193-30 | EA - Each | 63824-193 | f55e9eef-3a6b-42c7-9cfe-b7dd61da2d62 | 1 | 2014-04-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63824-193 | MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RB HEALTH (US) LLC] | 11 | Current NDC, Legacy NDC, 6 package rows | 20241222_3ff4c4ea-7628-4d2b-a6e9-d994c25baef4.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 |
|---|---|---|---|---|---|---|
| Allegra Allergy 24 hour | FEXOFENADINE HYDROCHLORIDE | Select Consumer Group | 2de81a41-8488-7e39-e063-6294a90a394b | 2026-06-01 | Warnings | M012 |
| Cough and Runny Nose Childrens Plus | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | TOP CARE (Topco Associates LLC) | 6f04bd51-093c-4624-aef3-0145ac387386 | 2026-06-01 | Warnings | M012 |
| Nasal | PHENYLEPHRINE HYDROCHLORIDE | CVS Pharmacy | 694a3116-1b75-42cd-bbcf-d19831c2d796 | 2026-06-01 | Warnings | M012 |
| night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | H E B | cf31538c-9eee-4c81-80cb-66eecabf0aff | 2026-06-01 | Warnings | M012 |
| Mucinex Childrens Mighty Chews Cough | DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 155e07b3-0a08-3be8-e063-6394a90a7635 | 2026-05-31 | Warnings | M012 |
| Mucinex Childrens Mighty Chews Cough Nighttime | DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Reckitt Benckiser LLC | 156033ae-b16a-007b-e063-6294a90a7445 | 2026-05-31 | Warnings | M012 |
| Cold and Flu Day | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Walgreen Company | ebf8c82d-a653-4c02-893b-61704901acbb | 2026-05-29 | Warnings | M012 |
| Allergy Relief Childrens | DIPHENHYDRAMINE HCL | Amerisource Bergen | 934c7b91-3cba-47f0-8efa-77216f3f15c4 | 2026-05-29 | Warnings | M012 |
| Allergy Medicine | DIPHENHYDRAMINE HCL | COSTCO WHOLESALE CORPORATION | d9f03e11-d11f-43ee-8ed0-9e07d1058f66 | 2026-05-29 | Warnings | M012 |
| Cold Childrens, Multi Symptom | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | eaa07dd4-cb7e-45ca-abe4-7a3f7a9d928d | 2026-05-29 | Warnings | M012 |
| NebuClear MD | RACEPINEPHRINE HYDROCHLORIDE | Blue Echo Care LLC | 3598ac5b-29f9-f002-e063-6294a90a62cb | 2026-05-28 | Warnings | M012 |
| NebuClear MD | RACEPINEPHRINE HYDROCHLORIDE | Blue Echo Care LLC | 51badd2f-4a43-3dbe-e063-6294a90a4bd1 | 2026-05-28 | Warnings | M012 |
| Kids Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Genexa Inc. | a7ab2140-de09-158f-e053-2a95a90a25a0 | 2026-05-28 | Warnings | M012 |
| Kids Multi Symptom Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Genexa Inc. | 2d918ec8-3098-1d09-e063-6294a90a9e8f | 2026-05-28 | Warnings | M012 |
| Daytime and Nighttime Kids Multi-Symptom Cold and Flu combo pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL | Genexa Inc. | 213fe898-dace-9a0f-e063-6394a90afd64 | 2026-05-28 | Warnings | M012 |
| MGC Health Cough Drops Honey Lemon Flavor | MENTHOL | Medical Group Care LLC | 556628ab-e233-92fe-e063-6394a90a0090 | 2026-05-28 | Warnings | M012 |
| Sinus Decongestion PE | PHENYLEPHRINE HCL | Kroger Company | 68eff734-177e-4999-9126-6b92bb204107 | 2026-05-28 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | ARMY AND AIR FORCE EXCHANGE SERVICE | ff39084f-ab2f-48ed-ac62-837f7fff2b65 | 2026-05-28 | Warnings | M012 |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Select Consumer Group LLC | 52c5fda0-c358-72e8-e063-6394a90a3f68 | 2026-05-27 | Warnings | M012 |
| Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack | DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Reckitt Benckiser LLC | 16637d54-8049-d3ce-e063-6394a90aafc9 | 2026-05-27 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1372652 | dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 3ff4c4ea-7628-4d2b-a6e9-d994c25baef4 | 12 |
| 1372652 | dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 3ff4c4ea-7628-4d2b-a6e9-d994c25baef4 | 12 |
| 1372652 | dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | SY | 3ff4c4ea-7628-4d2b-a6e9-d994c25baef4 | 12 |
| 2560238 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / triprolidine hydrochloride 1.25 MG Oral Tablet) / 1 (dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet) } Pack | GPCK | a401eb92-60b6-427d-a677-29371a3150be | 4 |
| 2560238 | 1 daytime (dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / triprolidine HCl 1.25 MG Oral Tablet) Pack | PSN | a401eb92-60b6-427d-a677-29371a3150be | 4 |
| 2549034 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / triprolidine HCl 1.25 MG Oral Tablet | PSN | a401eb92-60b6-427d-a677-29371a3150be | 4 |
| 1372652 | dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | a401eb92-60b6-427d-a677-29371a3150be | 4 |
| 2549034 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / triprolidine hydrochloride 1.25 MG Oral Tablet | SCD | a401eb92-60b6-427d-a677-29371a3150be | 4 |
| 1372652 | dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | a401eb92-60b6-427d-a677-29371a3150be | 4 |
| 2560238 | 1 daytime (dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / triprolidine HCl 1.25 MG Oral Tablet) Pack | SY | a401eb92-60b6-427d-a677-29371a3150be | 4 |
| 2549034 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / triprolidine hydrochloride 1.25 MG Oral Tablet | SY | a401eb92-60b6-427d-a677-29371a3150be | 4 |
| 1372652 | dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | SY | a401eb92-60b6-427d-a677-29371a3150be | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63824-193-20 | 63824019320 | 2 BLISTER PACK in 1 CARTON (63824-193-20) > 10 TABLET, COATED in 1 BLISTER PACK | 2 blister pack | 2013-03-15 | 0000-00-00 | No | No | Current |
| 63824-193-21 | 63824019321 | 2 BLISTER PACK in 1 CARTON (63824-193-21) / 10 TABLET, COATED in 1 BLISTER PACK | 2 blister pack | 2020-10-01 | 0000-00-00 | No | No | Current |
| 63824-193-30 | 63824019330 | 3 BLISTER PACK in 1 CARTON (63824-193-30) > 10 TABLET, COATED in 1 BLISTER PACK | 3 blister pack | 2013-03-15 | 0000-00-00 | No | No | Current |