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 |
|---|---|---|---|---|---|---|
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Walgreen Company | 0b34b5a3-98a2-4096-9d95-071bb5a63c86 | 2026-04-17 | Warnings | M012 |
| Mucus Relief | GUAIFENESIN | Walgreen Company | 1cd69ede-29c6-4216-95b7-b58fc96c084b | 2026-04-16 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Valu Merchandisers Company | cdcb8e0d-7847-4f28-bb09-7dc7b5d35c13 | 2026-04-16 | Warnings | M012 |
| Cold Multi-Symptom Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Valu Merchandisers Company | b0d9d869-9f0d-4834-aa2b-1ee21fd8b67b | 2026-04-16 | Warnings | M012 |
| Rompe Pecho Max | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN | Efficient Laboratories Inc | 4f86985c-48f3-2148-e063-6394a90ae2f1 | 2026-04-15 | Warnings | M012 |
| Childrens Daytime Mucus | DEXTROMETHORPHAN HBR | Walgreens | 7a55b7e1-1054-421e-847e-5e4d90d1aebb | 2026-04-15 | Warnings | M012 |
| Childrens Nighttime Mucus | DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | Walgreens | dc69f581-27c7-4030-bb18-39685c7691a1 | 2026-04-15 | Warnings | M012 |
| Pseudoephedrine HCl | PSEUDOEPHEDRINE HCL | Major Pharmaceuticals | da95c643-7122-4025-977f-42205080e56b | 2026-04-15 | Warnings | M012 |
| Daytime Nighttime Chewable | DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | Walgreens | 9ddc0aa7-e7b8-41c5-a2b4-fece0c2e26c6 | 2026-04-15 | Warnings | M012 |
| foster and thrive nasal | OXYMETAZOLINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 4f7090f4-89c9-c3da-e063-6294a90a4716 | 2026-04-14 | Warnings | M012 |
| Sinus and Headache | ACETAMINOPHEN, PHENYLEPHRINE HCL | Walgreen Company | 2115f095-2d75-4e02-a6af-22dd693e0840 | 2026-04-14 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Lidl US LLC | 00f89eee-0edc-40dc-9297-8645afb91004 | 2026-04-14 | Warnings | M012 |
| Sinus Pressure and Pain Daytime Nighttime Maximum Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 8647c136-a323-453a-8f57-e66938bbf639 | 2026-04-14 | Warnings | M012 |
| daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 5515148f-3e1d-4b03-89fa-40967d508292 | 2026-04-14 | Warnings | M012 |
| Mucus Relief Sinus Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | c70e6506-6c5b-4d3f-ab18-a690840caabc | 2026-04-13 | Warnings | M012 |
| Nasal Decongestant PE | PHENYLEPHRINE HCL | Walgreen Company | 48387b95-8240-4d6e-842b-cc29cc18709c | 2026-04-13 | Warnings | M012 |
| Sinufrin Plus No Drip Decongestant | NASAL CONGESTION RELIEF | NeilMed Pharmaceuticals Inc | 4f06c732-1f9f-bfc6-e063-6394a90a53f5 | 2026-04-13 | Warnings | M012 |
| Severe Sinus Congestion | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 8745d9d8-640d-4e3b-96fe-d25032c1e3ce | 2026-04-13 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Cardinal Health 107, LLC | 5a5c5f33-5b70-465d-a38b-6f518af09788 | 2026-04-13 | Warnings | M012 |
| Allergy | DIPHENHYDRAMINE HCL | Publix Super Markets Inc | f2263e38-f686-45ed-bf85-b47f5e1aa982 | 2026-04-13 | 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 |