Mucinex Fast-Max
- Product NDC
- 63824-591
- 11-digit product format
- 638240591
- Labeler code
- 63824
- Product ID
- 63824-591_51b46950-2d62-8fbc-e063-6294a90a76e6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Reckitt Benckiser LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-07-15
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 200; 5 mg/1; 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
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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 63824-591-16 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 63824-591-16 | bd6a592717d7… | 303034d00443… |
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
- Cold, Flu and Sore Throat
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1656815 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a3523aa3-9ed1-472d-9986-438440d0a3eb | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63824-591-16 | 2022-08-08 | C162847 | 48780-1 | d6a99b39-50ad-a426-e053-dadaa90af4c2 | Mucinex® Fast-Max ® Cold, Flu & Sore Throat |
| 63824-591-16 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-50ad-a426-e053-dadaa90af4c2 | Mucinex® Fast-Max ® Cold, Flu & Sore Throat |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63824-591-16 | Mucinex Fast-MaxCold, Flu and Sore Throat | 8 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 8 | 10 | |
| 63824-591-16 | Mucinex Fast-MaxCold, Flu and Sore Throat | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-591-16 | EA - Each | 63824-591 | fc2e079d-bbcc-4aa8-b185-34673df99f50 | 1 | 2015-08-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63824-591 | MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RB HEALTH (US) LLC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241222_a3523aa3-9ed1-472d-9986-438440d0a3eb.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 |
|---|---|---|---|---|---|---|
| Coricidin HBP Cold and Flu | ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE | Bayer HealthCare LLC. | 763a5334-a741-4678-9947-603776622450 | 2025-02-18 | Warnings | M012 |
| Sof Skin Vaporizing Chest Rub and Cough Suppressant | MENTHOL AND CAMPHOR AND EUCALYPTUS OIL | Viny Health and Beauty Inc | 46ae16a4-b8a7-44de-ae1a-9bb503c15ea0 | 2025-02-18 | Warnings | M012 |
| Pain Reliever PM | ACETAMINOPHEN DIPHENHYDRAMINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 4897d1df-4fb3-46e2-bbf0-847e964dca0a | 2025-02-18 | Warnings | M012 |
| meijer EXTRA STRENGTH Pain Relief PM Caplet | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Meijer, Inc. | 1bee7e4f-1813-1bdf-e063-6294a90a6a32 | 2025-02-17 | Warnings | M012 |
| ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCL | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAILFENESIN,PHENLYEPHRINE HCL | Kroger Company | a24f09d9-60f1-853a-e053-2a95a90ae1fa | 2025-02-15 | Warnings | M012 |
| MAXIMUM STRENGTH COLD AND FLU | ACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | FAMILY DOLLAR SERVICES | a7343bea-53cc-4621-e053-2a95a90a2a5f | 2025-02-15 | Warnings | M012 |
| MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULA | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL | FAMILY DOLLAR | aa8f6dd0-d19f-0c10-e053-2a95a90a1e8a | 2025-02-15 | Warnings | M012 |
| MAXIMUM STRENGHT DAY COLD AND FLU FORMULA | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL | FAMILY DOLLAR | aa8ebccf-6813-2dca-e053-2a95a90a032b | 2025-02-15 | Warnings | M012 |
| MAXIMUM STRENTH NIGHT COLD AND FLU FORMULA | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | FAMILY DOLLAR | aa8f0465-1595-0b0f-e053-2a95a90a0081 | 2025-02-15 | Warnings | M012 |
| DAYTIME SEVERE COLD AND FLU | ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN | KROGER COMPANY | 9bb7aaf0-6698-9a5c-e053-2a95a90a097c | 2025-02-14 | Warnings | M012 |
| Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | H-E-B | db432947-fe02-79b2-e053-2a95a90af4a9 | 2025-02-14 | Warnings | M012 |
| Halls Sugar Free Cherry | MENTHOL | Mondelez Global LLC | ea8dfe96-f6a4-4172-bf9e-ae3cf606ff50 | 2025-02-14 | Warnings | M012 |
| Halls Sugar Free Watermelon | MENTHOL | Mondelez Global LLC | c4c090ca-f083-74e0-e053-2a95a90a9d60 | 2025-02-14 | Warnings | M012 |
| Tukol Max Action | OXYMETAZOLINE HYDROCHLORIDE | Genomma Lab USA | 73358103-43dc-4b11-9c89-9a6ba45bf1af | 2025-02-14 | Warnings | M012 |
| Maximum Strength Mucus Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Chain Drug Marketing Association Inc. | 6c4e867b-24b9-4525-9fab-10f1e7910b13 | 2025-02-13 | Warnings | M012 |
| DAYTIME- NIGHTTIME COLD AND FLU | DAYTIME NIGHTTIME COLD AND FLU | TARGET CORP | 9def204a-ee1e-6868-e053-2995a90a76b8 | 2025-02-13 | Warnings | M012 |
| Daytime Cold and Flu and Nigttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | BETTER LIVING BRANDS LLC. | f2c11b63-278f-64de-e053-2995a90a5aae | 2025-02-12 | Warnings | M012 |
| Daytime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | BETTER LIVING BRANDS LLC. | f29c604a-271d-a702-e053-2a95a90a3427 | 2025-02-12 | Warnings | M012 |
| Nighttime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | BETTER LIVING BRANDS LLC. | f2c01090-645c-1efe-e053-2995a90a7df5 | 2025-02-12 | Warnings | M012 |
| AXIV DayTime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | VIVUNT PHARMA LLC | 131b1f17-cd86-f9b3-e063-6294a90a3028 | 2025-02-12 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1656815 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | a3523aa3-9ed1-472d-9986-438440d0a3eb | 10 |
| 1656815 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | a3523aa3-9ed1-472d-9986-438440d0a3eb | 10 |
| 1656815 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | a3523aa3-9ed1-472d-9986-438440d0a3eb | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63824-591-16 | 63824059116 | 2 BLISTER PACK in 1 CARTON (63824-591-16) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2 blister pack | 2015-07-15 | 0000-00-00 | No | No | Current |