Extra Strength TYLENOL Cold plus Flu Multi Symptom Day
- Product NDC
- 50580-586
- 11-digit product format
- 505800586
- Labeler code
- 50580
- Product ID
- 50580-586_5487d621-8c47-39b3-e063-6294a90a6f31
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen and Dextromethorphan Hydrobromide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-06-18
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
- Active strength
- 15; 500 mg/1; mg/1
- Pharmacologic classes
- Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 Cold plus Flu Multi Symptom Day
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/1 |
| ACETAMINOPHEN | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 247324 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5487b2e1-b0e5-0236-e063-6394a90a3a8b | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | FSA STORE INC. | ec6aef90-ece1-4fe6-e053-2995a90a9310 | 2024-10-16 | Warnings | M012 |
| Tukol MAX ACTION Cold, Sore Throat and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Genomma Lab USA, Inc | c8eebe64-00bf-436d-a9fc-1623401bebfa | 2024-10-16 | Warnings | M012 |
| Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Discount Drug Mart | 4f42c8d2-0538-4bcd-aac0-e26103a30499 | 2024-10-16 | Warnings | M012 |
| Tukol MAX ACTION Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Genomma Lab USA, Inc | 9ac3e24a-d18a-48fc-8005-55393085d57b | 2024-10-16 | Warnings | M012 |
| Nighttime Cough | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 45471fdd-c4cd-46ad-a932-aa37327e8a41 | 2024-10-16 | Warnings | M012 |
| DG Health Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp Inc | 8cb15a8d-c836-4167-bc6b-dd20a34076e8 | 2024-10-16 | Warnings | M012 |
| basic care nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | f4497e56-c69d-4ae9-bd81-80bf2ee1b17f | 2024-10-15 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | FOODHOLD U.S.A., LLC | 8256c1fb-683d-56ab-e053-2a91aa0ac197 | 2024-10-15 | Warnings | M012 |
| SINUS SEVRE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | 9f9586e3-a8b4-4060-e053-2995a90aa068 | 2024-10-15 | Warnings | M012 |
| ALLERGY RELIEF | DIPHENHYDRAMINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | 9f95715f-63dc-6086-e053-2a95a90adb0c | 2024-10-15 | Warnings | M012 |
| Allergy MultiSymptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | a61636e9-8fe2-8419-e053-2a95a90a011c | 2024-10-15 | Warnings | M012 |
| SINUS AND HEADACHE | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | 9f95b2e8-dea4-ef59-e053-2a95a90a0bcb | 2024-10-15 | Warnings | M012 |
| Cold Multi-Symptom Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | American Sales Company | d2dcbc7c-e66c-4922-83df-c706a37bf334 | 2024-10-15 | Warnings | M012 |
| Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. ( | 9f958d97-8dcf-332d-e053-2995a90a0a65 | 2024-10-15 | Warnings | M012 |
| Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Retail Business Services , LLC. | 8bc68a71-62c5-a04f-e053-2995a90a92fd | 2024-10-15 | Warnings | M012 |
| COLD FLU AND SORE THROAT | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | 9f960566-0158-6637-e053-2995a90a9c4a | 2024-10-15 | Warnings | M012 |
| HEAD CONGESTION PLUS FLU SEVERE PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | e65cf21d-3d69-a53e-e053-2a95a90a1c83 | 2024-10-15 | Warnings | M012 |
| night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | H E B | 49f5f4d3-556c-4ee3-b5cd-5331dd434bb9 | 2024-10-15 | Warnings | M012 |
| Mielim y mas | DEXTROMETHORPHAN | Efficient Laboratories Inc. | 711d1dae-3af4-46af-a3a8-cd827356a81a | 2024-10-14 | Warnings | M012 |
| Tukol Cough and Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | 27ab3d86-e960-4d83-aad1-d50d2c8e02a9 | 2024-10-14 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50580-586-01 | 50580058601 | 2 BLISTER PACK in 1 CARTON (50580-586-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2026-06-18 | No | No | Current |