EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT
- Product NDC
- 50580-551
- 11-digit product format
- 505800551
- Labeler code
- 50580
- Product ID
- 50580-551_3a190315-8b55-0724-e063-6294a90a7bb5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan hydrobromide, Chlorpheniramine Maleate
- Dosage form
- KIT
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-08-26
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 19ad2cca-c1cb-019c-e063-6294a90a5644 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-551-01 | EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT | 1 in 1 PACKAGE | KIT | 1 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50580-551 | EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE) KIT [KENVUE BRANDS LLC] | 3 | Current NDC, 1 package rows | 20241109_19ad2cca-c1cb-019c-e063-6294a90a5644.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 |
|---|---|---|---|---|
| 2604579 | {1 (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet) / 1 (acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG Oral Tablet) } Pack | GPCK | 19ad2cca-c1cb-019c-e063-6294a90a5644 | 4 |
| 2604579 | 1 daytime (acetaminophen 500 MG / dextromethorphan HBr 15 MG Oral Tablet) / 1 nighttime (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet) Pack | PSN | 19ad2cca-c1cb-019c-e063-6294a90a5644 | 4 |
| 1098496 | acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG Oral Tablet | PSN | 19ad2cca-c1cb-019c-e063-6294a90a5644 | 4 |
| 247324 | acetaminophen 500 MG /dextromethorphan HBr 15 MG Oral Tablet | PSN | 19ad2cca-c1cb-019c-e063-6294a90a5644 | 4 |
| 1098496 | acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet | SCD | 19ad2cca-c1cb-019c-e063-6294a90a5644 | 4 |
| 247324 | acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG Oral Tablet | SCD | 19ad2cca-c1cb-019c-e063-6294a90a5644 | 4 |
| 2604579 | 1 nighttime (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG Oral Tablet) / 1 daytime (acetaminophen 500 MG / dextromethorphan HBr 15 MG Oral Tablet) Pack | SY | 19ad2cca-c1cb-019c-e063-6294a90a5644 | 4 |
| 247324 | acetaminophen 500 MG /dextromethorphan HBr 15 MG Oral Tablet | SY | 19ad2cca-c1cb-019c-e063-6294a90a5644 | 4 |
| 1098496 | APAP 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet | SY | 19ad2cca-c1cb-019c-e063-6294a90a5644 | 4 |
| 247324 | APAP 500 MG / Dextromethorphan Hydrobromide 15 MG Oral Tablet | SY | 19ad2cca-c1cb-019c-e063-6294a90a5644 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50580-551-01 | 50580055101 | 1 KIT in 1 PACKAGE (50580-551-01) * 2 BLISTER PACK in 1 KIT / 8 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 KIT / 4 TABLET, FILM COATED in 1 BLISTER PACK | 1 kit | 2024-08-26 | No | No | Current |