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 | 2026-10-21 | |
| excluded package | package | 63824-193 | 63824-193-30 | 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 | 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 |
|---|---|---|---|---|---|---|
| Dr. Simi Nighttime Cold and Flu | ACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 15 MG, DOXYLAMINE SUCCINATE 6.25 MG | Farmacias De Similares TX LLC | 4e5772ee-586c-6191-e063-6294a90a132d | 2026-03-30 | Warnings | M012 |
| allergy | DIPHENHYDRAMINE HCL | HyVee Inc | 75b19163-db1c-42fc-8bbb-364be16b9b2f | 2026-03-30 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | HyVee Inc | a9f23c63-eeda-4de9-aec6-fe482f469e98 | 2026-03-27 | Warnings | M012 |
| Flu HBP Maximum Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | CHAIN DRUG MARKETING ASSOCIATION INC | 7d1b3418-85a8-4ca0-bca7-261b2b58032a | 2026-03-26 | Warnings | M012 |
| MAXIMUM STRENGTH COLD, FLU AND SORE THROAT | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS Pharmacy, Inc. | bfc38500-5706-0d03-e053-2995a90a5c72 | 2026-03-26 | Warnings | M012 |
| NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS HEALTH CORP | 2baa0861-dbef-7910-e063-6394a90a117e | 2026-03-26 | Warnings | M012 |
| MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF | ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL AND ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCL | CVS Pharmacy, Inc. | c17d5ba7-3302-7931-e053-2a95a90a5a6c | 2026-03-26 | Warnings | M012 |
| MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy, Inc. | c17b8f17-95f6-37e4-e053-2995a90a411a | 2026-03-26 | Warnings | M012 |
| Ultra concentrated Daytime/ Nighttime Severe Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE SOFTGEL | CVS PHARMACY, INC | 24cedaec-06a6-8fde-e063-6394a90a3d7a | 2026-03-26 | Warnings | M012 |
| MGC Health | COUGH DROPS HONEY SUGAR-FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 23079537-1c06-1373-e063-6394a90a37d2 | 2026-03-26 | Warnings | M012 |
| MGC Health | COUGH DROPS MENTHOL SUGAR-FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f2fa8c-071f-50ab-e063-6394a90a4a4a | 2026-03-26 | Warnings | M012 |
| Theraflu Flu Relief Max Strength Daytime Nighttime Value Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 2026-03-26 | Warnings | M012 |
| Vicks childrens Cough Congestion Night | PHENYLEPHRINE HYDROCHLORIDE AND DIPHENHYDRAMINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | 87231460-8b45-b995-e053-2a91aa0a6c43 | 2026-03-26 | Warnings | M012 |
| VICKS CHILDRENS COUGH CONGESTION | DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | f1d67797-c806-261d-e053-2a95a90a3c15 | 2026-03-26 | Warnings | M012 |
| childrens cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | HyVee Inc | 686f43ea-4296-4eee-b762-9a9e68344340 | 2026-03-26 | Warnings | M012 |
| Tussin DM Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 59d3a486-97c2-4e60-90e2-1b5bfa7638c7 | 2026-03-26 | Warnings | M012 |
| flu HBP Maximum Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Meijer Distribution Inc | 1a853e47-21a2-40e1-9e64-290af4843b13 | 2026-03-25 | Warnings | M012 |
| cold flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | HyVee Inc | c4dcc427-aeec-4a26-80f3-02a4b227a520 | 2026-03-25 | Warnings | M012 |
| Walgreens Lavender Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Walgreen Company | 327a1a00-852d-2756-e063-6394a90a5e29 | 2026-03-25 | Warnings | M012 |
| Walgreens Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Walgreen Company | 2d56ddcd-3cc8-51eb-e063-6394a90ae745 | 2026-03-25 | 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 |