Cold and Flu Daytime Relief
- Product NDC
- 50844-251
- 11-digit product format
- 508440251
- Labeler code
- 50844
- Product ID
- 50844-251_02bec796-c116-4fc3-bc25-388e0259ca61
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- L.N.K. International, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-07-20
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 5 mg/15mL; mg/15mL; mg/15mL
- Pharmacologic classes
- Adrenergic alpha1-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-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 50844-251 | 50844-251-02 | D | Discontinued by firm | 2026-10-21 |
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
- Cold and Flu Daytime Relief
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/15mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/15mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1113705 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1a520b4f-6a4b-4e37-94c5-9387f2e4c34a | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50844-251-02 | Cold and Flu Daytime Relief | 355 mL in 1 BOTTLE, PLASTIC | SOLUTION | 355 | 13 | |
| 50844-251-45 | Cold and Flu Daytime Relief | 177 mL in 1 BOTTLE, PLASTIC | SOLUTION | 177 | 13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50844-251 | COLD AND FLU DAYTIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [L.N.K. INTERNATIONAL, INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240719_1a520b4f-6a4b-4e37-94c5-9387f2e4c34a.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 |
|---|---|---|---|---|---|---|
| Antiflu Des Cough and Flu | ACETAMINOPHEN PHENYLEPHRINE HCL CHLORPHENIRAMINE MALEATE | Productos Farmaceuticos, S.A. de C.V. | dcf3897a-a793-6df7-e053-2995a90a25f8 | 2024-10-17 | Warnings | M012 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 1a520b4f-6a4b-4e37-94c5-9387f2e4c34a | 13 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 1a520b4f-6a4b-4e37-94c5-9387f2e4c34a | 13 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 1a520b4f-6a4b-4e37-94c5-9387f2e4c34a | 13 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 1a520b4f-6a4b-4e37-94c5-9387f2e4c34a | 13 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | 1a520b4f-6a4b-4e37-94c5-9387f2e4c34a | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50844-251-02 | 50844025102 | 355 mL in 1 BOTTLE, PLASTIC (50844-251-02) | 355 ml | 2019-07-20 | 0000-00-00 | No | No | Current |
| 50844-251-45 | 50844025145 | 177 mL in 1 BOTTLE, PLASTIC (50844-251-45) | 177 ml | 2019-07-20 | No | No | Current |