TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT
- Product NDC
- 50580-414
- 11-digit product format
- 505800414
- Labeler code
- 50580
- Product ID
- 50580-414_21ab6663-3be6-9926-e063-6294a90aa5db
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
- Dosage form
- KIT
- Labeler
- Kenvue Brands LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-07-18
- 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
- TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50580-414-03 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0097-111a-e063-dadaa90a10e2 | 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 |
| 50580-414-04 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0097-111a-e063-dadaa90a10e2 | 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-414-03 | TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT | 3 in 1 CELLO PACK | KIT | 3 | 17 | |
| 50580-414-04 | TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT | 1 in 1 CARTON | KIT | 1 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-414-01 | EA - Each | 50580-414 | 39e09cee-e584-495e-a75b-3a102e61366b | 1 | 2018-05-09 |
| 50580-414-04 | EA - Each | 50580-414 | 517056d5-1e2f-4576-9c51-fbda19d0189d | 1 | 2024-04-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50580-414 | TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC] | 17 | Current NDC, Legacy NDC, 2 package rows | 20241109_2ddb86a8-e34c-4a03-a60a-d3fedaf90608.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 |
|---|---|---|---|---|---|---|
| Severe Sinus Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE | Shield Pharmaceuticals Corp | d0dd4a75-da65-4c66-b65f-54ee14100846 | 2025-12-05 | Warnings | M012 |
| Basic Care Cherry Cough Drops | MENTHOL | Amazon.com | c0588221-0c84-66d8-e053-2995a90a874f | 2025-12-05 | Warnings | M012 |
| Basic Care Honey Lemon Cough Drops | MENTHOL | Amazon.com | c0937b13-f679-a764-e053-2a95a90abf89 | 2025-12-05 | Warnings | M012 |
| Basic Care SF Menthol Cough Drops | MENTHOL | Amazon.com | c0946295-7cf0-1bd8-e053-2a95a90af5af | 2025-12-05 | Warnings | M012 |
| Basic Care SF Honey Lemon Cough Drops | MENTHOL | Amazon.com | cf82fb0b-1b4d-def1-e053-2995a90a6fd9 | 2025-12-05 | Warnings | M012 |
| G-DOLOGEN | ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE | Kramer Novis | 7a4e1d64-2510-405f-a1dc-e02a803b6fbd | 2025-12-05 | Warnings | M012 |
| Quality Choice Severe Cold and Cough Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE | Chain Drug Manufacturing Assn | ce658dd5-b683-436e-b16b-0c06f6f87fd9 | 2025-12-04 | Warnings | M012 |
| Quality Choice Maximum Strength | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | a87ba15f-b5a9-4983-a721-ca7f705aea86 | 2025-12-04 | Warnings | M012 |
| Quality Choice | PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | a12e2e66-d2f3-47a6-a915-a309ae828d27 | 2025-12-04 | Warnings | M012 |
| Childrens Mucus Relief Chest Congestion | GUAIFENESIN | Chain Drug Manufacturing Assn | 034d39c0-9aad-4dff-a158-a041b9f0504f | 2025-12-04 | Warnings | M012 |
| Quality Choice | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | d01b8fb6-1ddf-4901-bda6-ae608e94a6a4 | 2025-12-04 | Warnings | M012 |
| Childrens Mucus and Cough Relief | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Chain Drug Manufacturing Assn | 06822a28-3f82-471d-8db5-c5981b263a03 | 2025-12-04 | Warnings | M012 |
| QUALITY CHOICE | PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | 14596551-dd82-46b3-8eb8-e69efaea105b | 2025-12-04 | Warnings | M012 |
| Daytime Cold and Flu Lil Drug Store Products | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc | fd5c20ed-5520-4db0-bfd4-995f043af2a4 | 2025-12-04 | Warnings | M012 |
| Afrin Original | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | 89c165ba-3ad5-49b5-a5bb-423dc8e15bad | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold Powerfast Fizz Night | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | a2b30c27-b836-f09f-e053-2995a90ac383 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | a37c9d9d-52db-23ff-e053-2995a90a8f76 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer Healthcare LLC. | dd7d8a8c-0f91-5ef1-e053-2a95a90a3c6a | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cough, Mucus and Congestion Day and Night Powermax | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | a68df74d-dd26-3ae9-e053-2995a90a08d6 | 2025-12-04 | Warnings | M012 |
| Circle K Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | 55662ada-677e-4048-9529-5bca44076316 | 2025-12-04 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2634819 | {1 (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet) } Pack | GPCK | 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 | 17 |
| 2634819 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 Oral Tablet) Pack | PSN | 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 | 17 |
| 1086991 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 | 17 |
| 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 | 17 |
| 1086991 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 | 17 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 | 17 |
| 2634819 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 Oral Tablet) Pack | SY | 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 | 17 |
| 1086991 | APAP 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 | 17 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 | 17 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50580-414-03 | 50580041403 | 3 CARTON in 1 CELLO PACK (50580-414-03) / 1 KIT in 1 CARTON (50580-414-04) * 2 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK | 3 carton | 2016-07-18 | 0000-00-00 | No | No | Current |
| 50580-414-04 | 50580041404 | 1 KIT in 1 CARTON (50580-414-04) * 2 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK | 1 kit | 2018-12-21 | 0000-00-00 | No | No | Current |