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 |
|---|---|---|---|---|---|---|
| Equate Wild Cherry Throat Drop | PECTIN | Walmart | 4d66547a-b72a-a0ac-e063-6394a90adc71 | 2026-03-19 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Safeway, Inc. | 45d44cd2-5187-4a5c-983a-edb1e8eba0b2 | 2026-03-19 | Warnings | M012 |
| Sedalmex XL Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Belmora LLC | f2edfedf-e06e-4d1b-8c2d-732e08ec113c | 2026-03-19 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | Bryant Ranch Prepack | 1e9887f6-209f-4f1f-9afa-a5ca649721cb | 2026-03-18 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Famora Inc. | 5a7bf4cd-1d44-424d-9ef4-d484e626e326 | 2026-03-18 | Warnings | M012 |
| Harris Teeter Menthol Cough Drops | MENTHOL | Harris Teeter | 4d502c1f-7307-ac50-e063-6294a90a6ff4 | 2026-03-18 | Warnings | M012 |
| Harris Teeter Cherry Cough Drops | MENTHOL | Harris Teeter | 4d50cc62-c84f-0761-e063-6394a90af54a | 2026-03-18 | Warnings | M012 |
| Harris Teeter Honey Lemon Cough Drops | MENTHOL | Harris Teeter | 4d516fce-d219-eee9-e063-6294a90ac59a | 2026-03-18 | Warnings | M012 |
| Harris Teeter SF Honey Lemon Cough Drops | MENTHOL | Harris Teeter | 4d524b45-260e-7411-e063-6294a90af639 | 2026-03-18 | Warnings | M012 |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Bryant Ranch Prepack | 9a77465c-6d3a-4399-9734-ad22e4b435db | 2026-03-18 | Warnings | M012 |
| good sense childrens cold cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Preferred Pharmaceuticals Inc. | a56d2fe4-5bea-4668-8e66-5a6f4279d461 | 2026-03-18 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Cardinal Health 110, LLC. DBA Leader | 4136e5f4-cc00-46d6-aa7f-ef56d087d7ec | 2026-03-18 | Warnings | M012 |
| M-Dryl | DIPHENHYDRAMINE HYDROCHLORIDE | Bryant Ranch Prepack | f9a0fb35-46d6-434f-8f9a-425a4bf50e84 | 2026-03-18 | Warnings | M012 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Grocery Outlet | 7398a372-7679-423b-a3ca-8da905a979dd | 2026-03-17 | Warnings | M012 |
| Allergy Relief | ALLERGY RELIEF | Grocery Outlet | 0661ddeb-6289-471e-af89-7f4b7452c355 | 2026-03-16 | Warnings | M012 |
| Daytime Cold and Cough Nighttime Cold and Congestion | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | CVS | 2cf361eb-6055-2364-e063-6294a90a69a1 | 2026-03-16 | Warnings | M012 |
| Severe Cold and Flu Relief Daytime/Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | b024ab38-e5da-4f5a-888f-e2a281578290 | 2026-03-16 | Warnings | M012 |
| good neighbor pharmacy night time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Amerisource Bergen | 41f87d59-3245-46dc-88a8-b947675a90fc | 2026-03-16 | Warnings | M012 |
| Childrens Cold and Cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE HCL | CVS | 2bc3eae8-ffe6-bc96-e063-6394a90a2283 | 2026-03-16 | Warnings | M012 |
| Daytime Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS HEALTH CORP | 23e2d2dc-12d4-294d-e063-6394a90a9523 | 2026-03-16 | 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 |