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 |
|---|---|---|---|---|---|---|
| TexaClear Pain and Chest Congestion Relief | CHOLINE SALICYLATE,GUAIFENESIN | GM Pharmaceuticals, INC | 672bc78a-2c71-4135-b64a-2b8c40ac688c | 2025-10-13 | Warnings | M012 |
| Vapor Stick | CAMPHOR/MENTHOL | Rejoice International Corp. | 33d1fbf3-d33c-58b9-e063-6294a90ae098 | 2025-10-13 | Warnings | M012 |
| Nitetime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Meijer Distribution Inc | 47f03174-6e91-4529-bbfa-ce58aa7b7d79 | 2025-10-13 | Warnings | M012 |
| Nasal Decongestant Maximum Strength | PSEUDOEPHEDRINE HCL | CHAIN DRUG MARKETING ASSOCIATION INC | db81e32b-0cad-400b-8479-a3b51de92b12 | 2025-10-10 | Warnings | M012 |
| Giltuss Childrens Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Gil Pharmaceutical Corp | 852b77ae-a5ac-3ead-e053-2a91aa0a54bd | 2025-10-09 | Warnings | M012 |
| Giltuss Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Gil Pharmaceutical Corp | 8503c956-42a5-7684-e053-2991aa0adb27 | 2025-10-09 | Warnings | M012 |
| Giltuss HBP Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Gil Pharmaceutical Corp | 852ceea2-d6a1-6de2-e053-2a91aa0ad50d | 2025-10-09 | Warnings | M012 |
| Giltuss Childrens Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Gil Pharmaceutical Corp | 852d5f01-9289-5515-e053-2a91aa0acf32 | 2025-10-09 | Warnings | M012 |
| Giltuss Diabetic Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Gil Pharmaceutical Corp | 85183b38-ce2a-0e0e-e053-2991aa0a336f | 2025-10-09 | Warnings | M012 |
| Giltuss MultiSymptom Cold and Flu | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Giltuss Pharmaceutical Corp | 8518fd91-981e-de78-e053-2a91aa0afcb2 | 2025-10-09 | Warnings | M012 |
| Giltuss Childrens MultiSymptom Cold and Flu | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Giltuss Pharmaceutical Corp | 852c8cd6-271f-0fa8-e053-2991aa0ab179 | 2025-10-09 | Warnings | M012 |
| Giltuss Allergy Plus Cough and Congestion | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Gil Pharmaceutical Corp | 85065cf3-386d-22d5-e053-2a91aa0a72da | 2025-10-09 | Warnings | M012 |
| Giltuss Honey Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Gil Pharmaceutical Corp | a8b2c847-25e9-8714-e053-2995a90a73ce | 2025-10-09 | Warnings | M012 |
| Giltuss Childrens Allergy Plus Cough and Congestion | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Gil Pharmaceutical Corp | 852c5a57-7ee4-3c5c-e053-2a91aa0a1433 | 2025-10-09 | Warnings | M012 |
| Childrens Giltuss Honey DM Cough | DEXTROMETHORPHAN HBR | Gil Pharmaceutical Corp | a8c5027f-9701-fb07-e053-2a95a90a6029 | 2025-10-09 | Warnings | M012 |
| Childrens Giltuss Honey Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Gil Pharmaceutical Corp | a8c052d8-fb9f-09f2-e053-2a95a90a37af | 2025-10-09 | Warnings | M012 |
| Giltuss EX Expectorant | GUAIFENESIN | Gil Pharmaceutical Corp | a8c53c14-ba82-2c68-e053-2a95a90a9894 | 2025-10-09 | Warnings | M012 |
| Giltuss Severe Sinus | OXYMETAZOLINE HCL | Gil Pharmaceutical Corp | ab7fae3b-1f7d-5d0f-e053-2a95a90a148e | 2025-10-09 | Warnings | M012 |
| Giltuss Honey DM Cough | DEXTROMETHORPHAN HBR | Gil Pharmaceutical Corp | a8c08532-1169-6603-e053-2a95a90a3484 | 2025-10-09 | Warnings | M012 |
| Childrens Giltuss EX Expectorant | GUAIFENESIN | Gil Pharmaceutical Corp | a8c59e6d-c11c-2664-e053-2a95a90a8333 | 2025-10-09 | 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 |