Cold and Flu Relief
- Product NDC
- 67091-260
- 11-digit product format
- 670910260
- Labeler code
- 67091
- Product ID
- 67091-260_77b95d40-205b-459d-8834-c3a7433b1cb8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- WinCo Foods, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-12-31
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 67091-260 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | ||
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 67091-260 | 67091-260-54 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 67091-260 | 67091-260-23 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… |
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 Relief
- Brand name suffix
- Multi Symptom Nighttime
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1043400 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 89272d2d-5533-4ae8-865b-cb204cec6d65 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67091-260-23 | Cold and Flu ReliefMulti Symptom Nighttime | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 | 6 | |
| 67091-260-54 | Cold and Flu ReliefMulti Symptom Nighttime | 355 mL in 1 BOTTLE, PLASTIC | LIQUID | 355 | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67091-260 | COLD AND FLU RELIEF MULTI SYMPTOM NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [WINCO FOODS, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240920_89272d2d-5533-4ae8-865b-cb204cec6d65.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 |
|---|---|---|---|---|---|---|
| oxymetazoline hcl | OXYMETAZOLINE HYDROCHLORIDE | Padagis Israel Pharmaceuticals Ltd | a1103cd8-344b-4a65-8a60-3c7be86d01a6 | 2024-09-11 | Warnings | M012 |
| Good Sense Nasal | OXYMETAZOLINE HYDROCHLORIDE | L. Perrigo Company | 276d7d3c-c4a7-4754-8845-c38f85aac5f7 | 2024-09-08 | Warnings | M012 |
| foster and thrive nasal | OXYMETAZOLINE HYDROCHLORIDE | Strategic Sourcing Services LLC | 4ff5a4ae-9649-4a6d-a5f8-ca23efbbb479 | 2024-09-08 | Warnings | M012 |
| equate nasal original | OXYMETAZOLINE HYDROCHLORIDE | Wal-Mart Stores Inc | 7e40c9b8-e0b5-448a-a674-72388fbab189 | 2024-09-08 | Warnings | M012 |
| Anefrin Nasal Original | OXYMETAZOLINE HYDROCHLORIDE | Walgreen Company | 85b442dc-1703-4fef-948a-fad7cbe9f224 | 2024-09-07 | Warnings | M012 |
| equaline nasal | OXYMETAZOLINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 07e0328e-1912-4f25-9e1e-9482d4665be0 | 2024-09-07 | Warnings | M012 |
| Benadryl Allergy EXTRA STRENGTH | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | dd0a8069-18d8-5696-e053-2995a90a2f22 | 2024-09-06 | Warnings | M012 |
| Guaifenesin and Codeine Phosphate | GUAIFENESIN AND CODEINE PHOSPHATE | PAI Holdings, LLC | 88d0994c-4270-4408-8837-bd97510b2118 | 2024-09-06 | Warnings | M012 |
| QCH Maximum Strength Mucus Relief 617 | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Chain Drug Marketing Association Inc. | a1c5c15e-0f3a-47d3-b9ed-1e0018417514 | 2024-09-06 | Warnings | M012 |
| Theraflu Severe Cold Relief Nighttime Soft Chews | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | 6ba64bbe-7599-406a-9187-737c0f8c1c2a | 2024-09-05 | Warnings | M012 |
| Cough Relief Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Best Choice (Valu Merchandisers Company) | 344282fc-3bd1-4f49-9bd1-08c5a58d1f73 | 2024-09-05 | Warnings | M012 |
| Equate Nasal | PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | 95ef1819-edc3-4dda-8514-85b61538cc72 | 2024-09-04 | Warnings | M012 |
| Up and up nasal | OXYMETAZOLINE HYDROCHLORIDE | Target Corporation | 0c246c11-eadd-4ac6-bd58-5fdb151e06d6 | 2024-09-04 | Warnings | M012 |
| Exchange Select Nasal | OXYMETAZOLINE HYDROCHLORIDE | Army & Air Force Exchange Service | aafa9163-f08e-48c9-9ca1-7b72f67d007d | 2024-08-31 | Warnings | M012 |
| nasal 12 hour | OXYMETAZOLINE HYDROCHLORIDE | Meijer Distribution Inc | e9ee03db-a070-4c2b-ac61-7fd22bab2795 | 2024-08-31 | Warnings | M012 |
| dg health nasal | OXYMETAZOLINE HYDROCHLORIDE | Dolgencorp, LLC | 42b58928-e8e5-49e4-b49e-498d77d64fcd | 2024-08-28 | Warnings | M012 |
| nasal | OXYMETAZOLINE HCL | Kroger Company | 0a24d98a-5950-49de-8b77-ea880b08d2c5 | 2024-08-28 | Warnings | M012 |
| basic care no drip nasal | OXYMETAZOLINE HYDROCHLORIDE | Amazon.com Services LLC | 96e018e2-e0b5-4802-a4a1-73a73d574082 | 2024-08-28 | Warnings | M012 |
| Topcare Nasal | OXYMETAZOLINE HCL | Topco Associates LLC | b5434599-5485-4949-9d76-b1ef3ad17c1a | 2024-08-28 | Warnings | M012 |
| basic care no drip nasal | OXYMETAZOLINE HYDROCHLORIDE | Amazon.com Services LLC | b15eb271-7842-495b-aa0f-9b20def86dc1 | 2024-08-28 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2637726 | {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) } Pack | GPCK | 4535fa03-64ac-4ec6-9d0c-b372bb12773b | 6 |
| 2637726 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution) Pack | PSN | 4535fa03-64ac-4ec6-9d0c-b372bb12773b | 6 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 4535fa03-64ac-4ec6-9d0c-b372bb12773b | 6 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 4535fa03-64ac-4ec6-9d0c-b372bb12773b | 6 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 89272d2d-5533-4ae8-865b-cb204cec6d65 | 6 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 4535fa03-64ac-4ec6-9d0c-b372bb12773b | 6 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 4535fa03-64ac-4ec6-9d0c-b372bb12773b | 6 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 89272d2d-5533-4ae8-865b-cb204cec6d65 | 6 |
| 2637726 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 mL Oral Solution) Pack | SY | 4535fa03-64ac-4ec6-9d0c-b372bb12773b | 6 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 4535fa03-64ac-4ec6-9d0c-b372bb12773b | 6 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 89272d2d-5533-4ae8-865b-cb204cec6d65 | 6 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 4535fa03-64ac-4ec6-9d0c-b372bb12773b | 6 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 4535fa03-64ac-4ec6-9d0c-b372bb12773b | 6 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 4535fa03-64ac-4ec6-9d0c-b372bb12773b | 6 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 89272d2d-5533-4ae8-865b-cb204cec6d65 | 6 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | 4535fa03-64ac-4ec6-9d0c-b372bb12773b | 6 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 4535fa03-64ac-4ec6-9d0c-b372bb12773b | 6 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 89272d2d-5533-4ae8-865b-cb204cec6d65 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 67091-260-23 | 67091026023 | 237 mL in 1 BOTTLE, PLASTIC (67091-260-23) | 237 ml | 2014-12-31 | No | No | Current |
| 67091-260-54 | 67091026054 | 355 mL in 1 BOTTLE, PLASTIC (67091-260-54) | 355 ml | 2014-12-31 | No | No | Current |