Extra Strength TYLENOL Cold Plus Flu Multi-Action
- Product NDC
- 50580-344
- 11-digit product format
- 505800344
- Labeler code
- 50580
- Product ID
- 50580-344_21702ebc-459b-7f5a-e063-6294a90ad432
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, Pseudoephedrine hydrochloride, and Dextromethorphan Hydrobromide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-06-21
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 15; 500; 30 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]
- 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 Cold Plus Flu Multi-Action
- Brand name suffix
- Day
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/1 |
| ACETAMINOPHEN | 500 mg/1 |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 30 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
| 6V9V2RYJ8N | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1250743 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7d3266dc-879a-4d28-b8ea-74d238c3020a | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| d17a97fa-387f-690e-d2be-0083ab044a03 | Product name | 3 | 20170725 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| e974e22d-8688-7d92-1e87-40c1079e170c | Product name | 3 | 20151125 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 4f26f669-fc6c-40ef-9e26-1c7b2390ee66 | Product name | 1 | 20140508 |
| 70a83adc-6047-bbea-5a08-dfd304aa47d2 | Product name | 1 | 20140508 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| 858ce051-9941-aafc-8c7c-44a8e0227463 | Product name | 1 | 20140508 |
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-344-01 | Extra Strength TYLENOL Cold Plus Flu Multi-ActionDay | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 8 | |
| 50580-344-01 | Extra Strength TYLENOL Cold Plus Flu Multi-ActionDay | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-344-01 | EA - Each | 50580-344 | bb42db4e-7a0c-40fb-ac80-ce52e5c2bac1 | 1 | 2021-08-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50580-344 | EXTRA STRENGTH TYLENOL COLD PLUS FLU MULTI-ACTION DAY (ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, FILM COATED [KENVUE BRANDS LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20241109_7d3266dc-879a-4d28-b8ea-74d238c3020a.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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1250743 | acetaminophen 500 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral Tablet | PSN | 7d3266dc-879a-4d28-b8ea-74d238c3020a | 8 |
| 1250743 | acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet | SCD | 7d3266dc-879a-4d28-b8ea-74d238c3020a | 8 |
| 1250743 | APAP 500 MG / Dextromethorphan Hydrobromide 15 MG / Pseudoephedrine Hydrochloride 30 MG Oral Tablet | SY | 7d3266dc-879a-4d28-b8ea-74d238c3020a | 8 |
| 2558505 | {1 (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet) / 1 (acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet) } Pack | GPCK | 712ba011-79aa-469b-9f0f-04a0b4b705bd | 6 |
| 2558505 | 1 daytime (acetaminophen 500 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral Tablet) / 1 nighttime (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral Tablet) Pack | PSN | 712ba011-79aa-469b-9f0f-04a0b4b705bd | 6 |
| 1089968 | acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral Tablet | PSN | 712ba011-79aa-469b-9f0f-04a0b4b705bd | 6 |
| 1250743 | acetaminophen 500 MG / dextromethorphan HBr 15 MG / pseudoephedrine HCl 30 MG Oral Tablet | PSN | 712ba011-79aa-469b-9f0f-04a0b4b705bd | 6 |
| 1089968 | acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet | SCD | 712ba011-79aa-469b-9f0f-04a0b4b705bd | 6 |
| 1250743 | acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet | SCD | 712ba011-79aa-469b-9f0f-04a0b4b705bd | 6 |
| 2558505 | 1 daytime (acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet) / 1 nighttime (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet) Pack | SY | 712ba011-79aa-469b-9f0f-04a0b4b705bd | 6 |
| 1089968 | APAP 500 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 15 MG / Pseudoephedrine Hydrochloride 30 MG Oral Tablet | SY | 712ba011-79aa-469b-9f0f-04a0b4b705bd | 6 |
| 1250743 | APAP 500 MG / Dextromethorphan Hydrobromide 15 MG / Pseudoephedrine Hydrochloride 30 MG Oral Tablet | SY | 712ba011-79aa-469b-9f0f-04a0b4b705bd | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50580-344-01 | 50580034401 | 2 BLISTER PACK in 1 CARTON (50580-344-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2021-06-21 | 0000-00-00 | No | No | Current |