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 |
|---|---|---|---|---|---|---|
| TexaClear Pain and Chest Congestion Relief | CHOLINE SALICYLATE,GUAIFENESIN | GM Pharmaceuticals, INC | 672bc78a-2c71-4135-b64a-2b8c40ac688c | 2025-10-13 | Warnings | M012 |
| Vapor Stick | CAMPHOR/MENTHOL | Rejoice International Corp. | 33d1fbf3-d33c-58b9-e063-6294a90ae098 | 2025-10-13 | Warnings | M012 |
| Nitetime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Meijer Distribution Inc | 47f03174-6e91-4529-bbfa-ce58aa7b7d79 | 2025-10-13 | Warnings | M012 |
| Nasal Decongestant Maximum Strength | PSEUDOEPHEDRINE HCL | CHAIN DRUG MARKETING ASSOCIATION INC | db81e32b-0cad-400b-8479-a3b51de92b12 | 2025-10-10 | Warnings | M012 |
| Giltuss Childrens Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Gil Pharmaceutical Corp | 852b77ae-a5ac-3ead-e053-2a91aa0a54bd | 2025-10-09 | Warnings | M012 |
| Giltuss Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Gil Pharmaceutical Corp | 8503c956-42a5-7684-e053-2991aa0adb27 | 2025-10-09 | Warnings | M012 |
| Giltuss HBP Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Gil Pharmaceutical Corp | 852ceea2-d6a1-6de2-e053-2a91aa0ad50d | 2025-10-09 | Warnings | M012 |
| Giltuss Childrens Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Gil Pharmaceutical Corp | 852d5f01-9289-5515-e053-2a91aa0acf32 | 2025-10-09 | Warnings | M012 |
| Giltuss Diabetic Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Gil Pharmaceutical Corp | 85183b38-ce2a-0e0e-e053-2991aa0a336f | 2025-10-09 | Warnings | M012 |
| Giltuss MultiSymptom Cold and Flu | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Giltuss Pharmaceutical Corp | 8518fd91-981e-de78-e053-2a91aa0afcb2 | 2025-10-09 | Warnings | M012 |
| Giltuss Childrens MultiSymptom Cold and Flu | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Giltuss Pharmaceutical Corp | 852c8cd6-271f-0fa8-e053-2991aa0ab179 | 2025-10-09 | Warnings | M012 |
| Giltuss Allergy Plus Cough and Congestion | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Gil Pharmaceutical Corp | 85065cf3-386d-22d5-e053-2a91aa0a72da | 2025-10-09 | Warnings | M012 |
| Giltuss Honey Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Gil Pharmaceutical Corp | a8b2c847-25e9-8714-e053-2995a90a73ce | 2025-10-09 | Warnings | M012 |
| Giltuss Childrens Allergy Plus Cough and Congestion | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Gil Pharmaceutical Corp | 852c5a57-7ee4-3c5c-e053-2a91aa0a1433 | 2025-10-09 | Warnings | M012 |
| Childrens Giltuss Honey DM Cough | DEXTROMETHORPHAN HBR | Gil Pharmaceutical Corp | a8c5027f-9701-fb07-e053-2a95a90a6029 | 2025-10-09 | Warnings | M012 |
| Childrens Giltuss Honey Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Gil Pharmaceutical Corp | a8c052d8-fb9f-09f2-e053-2a95a90a37af | 2025-10-09 | Warnings | M012 |
| Giltuss EX Expectorant | GUAIFENESIN | Gil Pharmaceutical Corp | a8c53c14-ba82-2c68-e053-2a95a90a9894 | 2025-10-09 | Warnings | M012 |
| Giltuss Severe Sinus | OXYMETAZOLINE HCL | Gil Pharmaceutical Corp | ab7fae3b-1f7d-5d0f-e053-2a95a90a148e | 2025-10-09 | Warnings | M012 |
| Giltuss Honey DM Cough | DEXTROMETHORPHAN HBR | Gil Pharmaceutical Corp | a8c08532-1169-6603-e053-2a95a90a3484 | 2025-10-09 | Warnings | M012 |
| Childrens Giltuss EX Expectorant | GUAIFENESIN | Gil Pharmaceutical Corp | a8c59e6d-c11c-2664-e053-2a95a90a8333 | 2025-10-09 | 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 |