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 |
|---|---|---|---|---|---|---|
| Freegells Cough Drops Menthol Honey Lemon 80ct | MENTHOL | R.L. ALBERT & SON, INC | 61deea94-d0a9-4563-926b-53f255a7c425 | 2025-10-08 | Warnings | M012 |
| FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPS | MENTHOL | R.L. ALBERT & SON, INC | c6b36350-386b-4346-bef0-a37ec11319c0 | 2025-10-08 | Warnings | M012 |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Strategic Sourcing Services LLC | 3314b174-d5bb-4843-9288-9b9c5fce79d5 | 2025-10-08 | Warnings | M012 |
| OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution | DIPHENHYDRAMINE HCL | MEDWISE LIFESCIENCES INC. | 407b7cbb-7ebd-7b7e-e063-6394a90af501 | 2025-10-06 | Warnings | M012 |
| Quality Choice Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) | d0cce0a0-a6bc-4c45-b9c6-08865b61c1dc | 2025-10-06 | Warnings | M012 |
| Halls Sugar Free Honey Lemon | MENTHOL | Mondelez Global LLC | 2b19fdd2-8088-47f2-be20-f220a6b825fc | 2025-10-06 | Warnings | M012 |
| Giltuss Childrens Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Dextrum Laboratories, Inc | 40802fb6-c1ec-d7b0-e063-6394a90ab423 | 2025-10-06 | Warnings | M012 |
| Giltuss Diabetic | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Dextrum Laboratories, Inc | 3f64c81a-bbfc-4575-e063-6294a90a6ed7 | 2025-10-06 | Warnings | M012 |
| TexaClear Severe Cough, Cold and Flu | CHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | GM Pharmaceuticals, INC | cb99e5b3-1908-43c9-b31f-d35e7ce58b44 | 2025-10-06 | Warnings | M012 |
| RoboHBr Cough SUPPRESSANT | DEXTROMETHORPHAN HBR | DXM Pharmaceutical, Inc | 0af624ce-191f-45e1-882b-e8acb90cc77b | 2025-10-06 | Warnings | M012 |
| RoboTablets | DEXTROMETHORPHAN | DXM Pharmaceutical, Inc | b92cf698-032d-4d8d-b19c-456c6338b094 | 2025-10-06 | Warnings | M012 |
| SinuLief | LORATADINE | RoseWell Pharmaceuticals LLC | 32619143-a782-3497-e063-6394a90aaaec | 2025-10-06 | Warnings | M012 |
| STAHIST AD | CHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | Magna Pharmaceuticals, Inc. | ccedbc38-2479-4c35-9f86-a9f29bcfab3f | 2025-10-03 | Warnings | M012 |
| Childrens PediaClear 8 | PYRILAMINE MALEATE | GM Pharmaceuticals, INC | 8e524967-d01c-4c93-9198-c42f15fe3fe0 | 2025-10-03 | Warnings | M012 |
| Childrens PediaClear PD | TRIPROLIDINE HYDROCHLORIDE | GM Pharmaceuticals, INC | f3ede5b7-1b0f-493a-b647-4459affc7e54 | 2025-10-03 | Warnings | M012 |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | InvaTech Pharma Solutions LLC | 40288ecf-043d-eb9e-e063-6394a90ac0a7 | 2025-10-02 | Warnings | M012 |
| Guaifenesin 400 | GUAIFENESIN TABLETS 400 | InvaTech Pharma Solutions LLC | 40291505-55ca-0759-e063-6394a90acee1 | 2025-10-02 | M012 | |
| CVS Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | CVS Pharmacy | 3dd5b783-5b64-24b5-e063-6394a90ab4ee | 2025-10-02 | Warnings | M012 |
| Acetaminophen and Diphenhydramine citrate | ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE | InvaTech Pharma Solutions LLC | 403a88fa-e06b-9b6e-e063-6394a90a97b8 | 2025-10-02 | Warnings | M012 |
| Equaline childrens cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | United Natural Foods, Inc. dba UNFI | 3053f6d7-0eff-488c-8901-770dcc62af06 | 2025-10-02 | 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 |