Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nightshift Cold and Flu
- Product NDC
- 63824-117
- 11-digit product format
- 638240117
- Labeler code
- 63824
- Product ID
- 63824-117_4ef878df-7224-bd97-e063-6294a90a490b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, and TRIPROLIDINE HYDROCHLORIDE
- Dosage form
- KIT
- Labeler
- Reckitt Benckiser LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-06-24
- 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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | 63824-117 | I | Inactivated by FDA | excluded / ndc_excluded.zip | fb8cb913e6d1… | eb8c232b6be0… | ||
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 63824-117 | 63824-117-66 | I | Inactivated by FDA | excluded / ndc_excluded.zip | fb8cb913e6d1… | eb8c232b6be0… |
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 Severe Congestion and Cough and Mucinex Nightshift Cold and Flu
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4592d547-556f-4eec-8faf-6ff9a92e46c8 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63824-117-66 | 2022-11-16 | C162847 | 48780-1 | e4f33bdf-a3f7-d8a0-e053-dadaa90a6e4e | Mucinex® Fast-Max ® Severe Congestion & Cough and Mucinex® Nightshift Cold & Flu |
| 63824-117-66 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-a3f7-d8a0-e053-dadaa90a6e4e | Mucinex® Fast-Max ® Severe Congestion & Cough and Mucinex® Nightshift Cold & Flu |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63824-117-66 | Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nightshift Cold and Flu | 1 in 1 CARTON | KIT | 1 | 5 | |
| 63824-503-66 | Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nightshift Cold and Flu | 180 mL in 1 BOTTLE | SOLUTION | 180 mL | 650 mg in 20mL | 5 |
| 63824-540-66 | Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nightshift Cold and Flu | 180 mL in 1 BOTTLE | SOLUTION | 180 mL | 400 mg in 20mL | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-117-66 | ML - Milliliter | 63824-117 | 34c69e07-4e5f-46d0-80c7-bd3b488d2c3d | 1 | 2022-07-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63824-117 | MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH AND MUCINEX NIGHTSHIFT COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) KIT [RB HEALTH (US) LLC] | 4 | Current NDC, Legacy NDC, 3 package rows | 20241222_4592d547-556f-4eec-8faf-6ff9a92e46c8.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 |
|---|---|---|---|---|---|---|
| Mucinex Fast-Max Severe Congestion and Cough | GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 1991d5ee-fc90-4070-8965-cd6f4abc45cf | 2026-05-13 | Warnings | M012 |
| Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc | 2026-05-13 | Warnings | M012 |
| Mucinex Fast-Max DM Max and Mucinex Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 3ba2cc08-acad-79a8-e063-6394a90af17f | 2026-05-13 | Warnings | M012 |
| Mucinex Fast-Max Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | a3523aa3-9ed1-472d-9986-438440d0a3eb | 2026-05-13 | Warnings | M012 |
| Mucinex Fast-Max DM Max and Mucinex Nightshift Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 2ed3c844-0532-40d9-beba-738d196de34d | 2026-05-13 | Warnings | M012 |
| Mucinex Sinus-Max Severe Congestion and Pain | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 1e243dbe-138f-4346-ba22-ceea01e97052 | 2026-05-13 | Warnings | M012 |
| Mucinex Nightshift Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | a14bc0d1-9b05-4a21-aaa8-95d4d073b9ed | 2026-05-13 | Warnings | M012 |
| Mucinex Sinus-Max Severe Congestion Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 128f3442-9802-4303-80be-aead09237936 | 2026-05-13 | Warnings | M012 |
| Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool | OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESIN | Reckitt Benckiser LLC | 33f0d9bb-c67d-92ba-e063-6294a90a9943 | 2026-05-13 | Warnings | M012 |
| Mucinex Sinus-Max Severe Congestion and Pain, Maximum Strength | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 2c01962d-74e3-4dfa-b7cb-a91a687711d5 | 2026-05-13 | Warnings | M012 |
| Mucinex Sinus-Max Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | f5365c6d-9296-41a5-953a-d1008954e67f | 2026-05-13 | Warnings | M012 |
| Mucinex Sinus-Max Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 8905706b-b9da-4520-8cf2-87d7c125edf3 | 2026-05-13 | Warnings | M012 |
| MUCINEX Rapid Clear Day Night and Clear and Cool Nasal | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE, AND OXYMETAZOLINE HYDROCHLORIDE | Reckitt Benckiser LLC | 37dcb0ed-df56-1bec-e063-6394a90a695e | 2026-05-13 | Warnings | M012 |
| Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool | OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESIN | Reckitt Benckiser LLC | 373e0d75-8def-4b98-e063-6394a90a5e47 | 2026-05-13 | Warnings | M012 |
| MUCINEX SINUS-MAX SEVERE NASAL CONGESTION RELIEF CLEAR and COOL NASAL | OXYMETAZOLINE HYDROCHLORIDE | Reckitt Benckiser LLC | 5a397466-8721-4060-a178-5ebfd7069cc9 | 2026-05-13 | Warnings | M012 |
| Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough | ACETAMINOPHEN, GUAIFENESIN | Reckitt Benckiser LLC | 350764de-7801-b24e-e063-6394a90ab3c3 | 2026-05-13 | Warnings | M012 |
| Cepacol Extra Strength Sore Throat and Cough | BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | c0cc32db-90f0-4106-8538-89821083ece1 | 2026-05-13 | Warnings | M012 |
| Mucinex Nightshift Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 316b5569-b66f-f30c-e063-6394a90ae147 | 2026-05-13 | Warnings | M012 |
| Mucinex Nightshift Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | d9467ca2-df75-4fa1-92b3-d2101eb54a77 | 2026-05-13 | Warnings | M012 |
| Mucinex Nightshift Severe Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 12420092-3ef6-464b-9106-2d56cd6ef200 | 2026-05-13 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2390630 | {1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } Pack | GPCK | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 5 |
| 2390630 | 1 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution) Pack | PSN | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 5 |
| 2173667 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution | PSN | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 5 |
| 1043543 | dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 5 |
| 2173667 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution | SCD | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 5 |
| 1043543 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 5 |
| 2390630 | 1 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG per 20 ML Oral Solution) Pack | SY | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 5 |
| 2173667 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral Solution | SY | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 5 |
| 2173667 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral Solution | SY | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 5 |
| 1043543 | dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 5 |
| 1043543 | dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution | SY | 4592d547-556f-4eec-8faf-6ff9a92e46c8 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63824-117-66 | 63824011766 | 1 KIT in 1 CARTON (63824-117-66) * 180 mL in 1 BOTTLE (63824-503-66) * 180 mL in 1 BOTTLE (63824-540-66) | 1 kit | 2022-06-30 | 0000-00-00 | No | No | Current |
| 63824-503-66 | 63824050366 | 180 mL in 1 BOTTLE | 180 ml | Historical | ||||
| 63824-540-66 | 63824054066 | 180 mL in 1 BOTTLE | 180 ml | Historical |