Mucus Relief Cold and Flu All in One
- Product NDC
- 63868-589
- 11-digit product format
- 638680589
- Labeler code
- 63868
- Product ID
- 63868-589_2435b3e0-536c-f685-e063-6394a90a6a77
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- CHAIN DRUG MARKETING ASSOCIATION INC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-12-01
- Marketing end
- 2027-01-31
- 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
- Current FDA listing
- Yes
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
- Mucus Relief Cold and Flu All in One
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 |
|---|---|
| 1110988 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ff433512-55b7-4fc9-8a55-aff5cbb749ef | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63868-589-20 | Mucus Relief Cold and Flu All in One | 2 in 1 CARTON | TABLET, COATED | 2 | 4 | |
| 63868-589-20 | Mucus Relief Cold and Flu All in One | 10 in 1 BLISTER PACK | TABLET, COATED | 10 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63868-589-20 | EA - Each | 63868-589 | 8671f248-698d-48bb-adb9-af9d4342cdc6 | 1 | 2022-12-07 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63868-589 | MUCUS RELIEF COLD AND FLU ALL IN ONE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241013_ff433512-55b7-4fc9-8a55-aff5cbb749ef.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 |
|---|---|---|---|---|---|---|
| Tussin DM Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Safeway, Inc. | 6fefff08-13b0-47eb-aa32-8d7e4deeae7b | 2025-11-05 | Warnings | M012 |
| Menthol Drops Freegells Extra Strong Eucalyptus 30ct | MENTHOL | R.L. ALBERT & SON, INC | 165a8efa-2b03-4329-99fa-3233f0af7d08 | 2025-11-04 | Warnings | M012 |
| Menthol Drops Freegells Extra Strong Honey Lemon 30ct | MENTHOL | R.L. ALBERT & SON, INC | f9ea46fc-0b04-444e-95fc-09aff7e7978a | 2025-11-04 | Warnings | M012 |
| QUALITY CHOICE Maximum Strength Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association, Inc. | 40413cdb-68ac-70e1-e063-6394a90a9217 | 2025-11-04 | Warnings | M012 |
| Tussin CF | DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL | WinCo Foods, LLC | 73fec783-1594-447b-b059-49ea9dbb5bee | 2025-11-04 | Warnings | M012 |
| Texaclear Fast Acting Allergy Relief | CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE | GM Pharmaceuticals, INC | 17a2f643-fa98-21ee-e054-00144ff88e88 | 2025-11-03 | Warnings | M012 |
| Cold plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 3e618bc7-0f51-e586-e063-6294a90afe37 | 2025-11-03 | Warnings | M012 |
| Head Congestion plus Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 3e61b5b3-ad15-01bf-e063-6394a90a6ec3 | 2025-11-03 | Warnings | M012 |
| Cold plus Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 409540c0-1bab-9969-e063-6394a90a47c1 | 2025-11-03 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 3e60b340-bd60-9318-e063-6294a90ad079 | 2025-11-03 | Warnings | M012 |
| Sinus Pressure and Pain PE | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 3e60e32f-3e5f-b775-e063-6294a90a097d | 2025-11-03 | Warnings | M012 |
| Sinus and Headache | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | HYVEE INC | 3e614265-b35a-5d01-e063-6294a90aad85 | 2025-11-03 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | HYVEE INC | 3e60b0ed-889d-0f17-e063-6394a90a4694 | 2025-11-03 | Warnings | M012 |
| VANACOF DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | GM Pharmaceuticals, INC | 2ed699f2-d004-4fa9-8042-6c85a9ff69b6 | 2025-11-03 | Warnings | M012 |
| Geri Dryl | DIPHENHYDRAMINE HCL | VERITYRX, LLC | 42a05f69-0599-5571-e063-6394a90a37d3 | 2025-11-02 | Warnings | M012 |
| M-Dryl | DIPHENHYDRAMINE HYDROCHLORIDE | VERITYRX, LLC | 42a0e577-a1b6-2c16-e063-6294a90af8e3 | 2025-11-02 | Warnings | M012 |
| Severe Sinus Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE | Shield Pharmaceuticals Corp | c296efd0-5030-4a26-a9b0-e66423d995dc | 2025-10-31 | Warnings | M012 |
| Daytime Cold and Flu Max Maximum Strength Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Topco Associates, LLC | f7ebe482-cb22-4517-8463-3432cf60071d | 2025-10-31 | Warnings | M012 |
| Nighttime Cold and Flu Max Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Topco Associates, LLC | 787bff76-0ee2-4e7e-b908-876e4a3e3bfc | 2025-10-31 | Warnings | M012 |
| Honey Lemon Cough Drops | MENTHOL | Trader Joe's Company | 647dadae-f37a-8399-e053-2991aa0aedb3 | 2025-10-31 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | ff433512-55b7-4fc9-8a55-aff5cbb749ef | 4 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | ff433512-55b7-4fc9-8a55-aff5cbb749ef | 4 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | ff433512-55b7-4fc9-8a55-aff5cbb749ef | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63868-589-20 | 63868058920 | 2 BLISTER PACK in 1 CARTON (63868-589-20) / 10 TABLET, COATED in 1 BLISTER PACK | 2 blister pack | 2020-12-08 | 2027-01-31 | No | No | Current |