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 | 2026-10-23 | |
| excluded package | package | 63824-193 | 63824-193-30 | D | Discontinued by firm | 2026-10-23 |
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 |
|---|---|---|---|---|---|---|
| S2 | RACEPINEPHRINE HYDROCHLORIDE | Nephron Pharmaceuticals Corporation | dd1b35c7-b23b-4b95-8162-df3d263fe32e | 2026-01-26 | Warnings | M012 |
| SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 0d97c634-0975-42d5-8ade-2ed2018cfe9d | 2026-01-26 | Warnings | M012 |
| GOOD SENSE NIGHT TIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | L. Perrigo Company | cd68289b-3850-40c6-9439-aae0e2d7637d | 2026-01-26 | Warnings | M012 |
| Seacall Nasal Spray. | NASAL SPRAY | Guangdong Quadrant Ecological Technology Co., Ltd. | 1f12618b-7461-fb47-e063-6294a90af753 | 2026-01-23 | Warnings | M012 |
| daytime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | ecf7d210-102c-4053-81f6-67116de6cf7b | 2026-01-23 | Warnings | M012 |
| Good Neighbor Pharmacy Day Time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amerisource Bergen | 44f9255b-0bf9-4573-ac9c-410acb515bc2 | 2026-01-23 | Warnings | M012 |
| Daytime cold and flu non drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Meijer Distribution Inc | 29caa3a7-7fe6-4134-a9b0-49bdb9280ca7 | 2026-01-23 | Warnings | M012 |
| good neighbor pharmacy night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Amerisource Bergen | e2b5c27e-ca5f-4503-a3ce-c86e1d8070a7 | 2026-01-23 | Warnings | M012 |
| RAYO ACTIVE ICE | MENTHOL, CAMPHOR | Quimicas Handal de Centroamerica SA de CV | 09e4a36b-020a-c5b1-e063-6394a90a3e31 | 2026-01-22 | Warnings | M012 |
| DRX CHOICE NIGHTTIME COLD and FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Raritan Pharmaceuticals Inc. | f466fc0e-3384-4884-832e-99bf1fdcf899 | 2026-01-21 | Warnings | M012 |
| Tussin DM | DEXTROMETHORPHAN HBR GUAIFENESIN | Strategic Sourcing Services LLC | 84750bfb-9e94-40a3-b731-21799f5e4fd1 | 2026-01-20 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Amerisource Bergen | 0b58990f-2246-408e-9365-51f56bb6766c | 2026-01-20 | Warnings | M012 |
| NightTime Cold and Flu Multi Symptom | ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | a8460fc9-2d08-4e5f-8dd3-5135ecda5923 | 2026-01-20 | Warnings | M012 |
| Mucus Relief DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Family Dollar Services Inc | 0a651316-623e-41eb-ab3a-641f5d807425 | 2026-01-20 | Warnings | M012 |
| Walgreens Maximum Strength Non Drowsy Day and Night Cold and Flu | WALGREENS MAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLU | Walgreens | 579c47c8-6366-4785-9680-d3986ce9641d | 2026-01-19 | Warnings | M012 |
| Walgreens Maximum Strength Non-Drowsy Day and Night Sinus and Cold | WALGREENS MAXIMUM STRENGTH NON-DROWSY DAY AND NIGHT SINUS AND COLD | Walgreens | dd61c9d3-0b70-450e-9525-282710b383cc | 2026-01-19 | Warnings | M012 |
| Sinus Severe Ultra Fine Mist | OXYMETAZOLINE HYDROCHLORIDE. | VIVUNT PHARMA LLC | 48bf7422-38ef-d4b4-e063-6294a90aa3ab | 2026-01-19 | Warnings | M012 |
| Cold and Flu Daytime, Nighttime, Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreens | fc670515-a820-4ea7-8786-8ae710798b31 | 2026-01-19 | Warnings | M012 |
| Allergy Relief Dye Free | DIPHENHYDRAMINE HCL | WALGREENS | 9dece7b1-00b1-2499-e053-2a95a90a0be3 | 2026-01-19 | Warnings | M012 |
| SEVERE COLD AND FLU DAYTIME NON DROWSY and NIGHTTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE / ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Walgreens | 2dba2bec-e0e3-4910-89c5-ebc093e05bec | 2026-01-19 | 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 |