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 |
|---|---|---|---|---|---|---|
| Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | American Health Packaging | 4cd8aee3-5522-434b-a1b1-9591bed3e9a6 | 2024-08-04 | Warnings | M012 |
| Guaifenesin DM | GUAIFENESIN AND DEXTROMETHORPHAN | American Health Packaging | 8632a655-7f5b-450f-95fa-62478a174e9c | 2024-08-04 | Warnings | M012 |
| Guaifenesin DM | GUAIFENESIN AND DEXTROMETHORPHAN | American Health Packaging | 990906b3-c566-4f35-923c-060202ba48e0 | 2024-08-04 | Warnings | M012 |
| Honey Lemon Flavor Cough Drops | HONEY LEMON FLAVOR MENTHOL | WHOLE FOODS MARKET, INC. | 1eb7abdc-061f-0e18-e063-6294a90a3a65 | 2024-08-02 | Warnings | M012 |
| Herbal Flavor Menthol Cough Drops | HERBAL FLAVOR MENTHOL COUGH DROPS | WHOLE FOODS MARKET, INC. | 1eb848b6-3dec-5b5f-e063-6394a90aea14 | 2024-08-02 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL COUGH DROPS | WHOLE FOODS MARKET, INC. | 1eb8927b-22c5-2ca3-e063-6294a90aa563 | 2024-08-02 | Warnings | M012 |
| No Drip Severe Anefrin Nasal | 0.05% OXYMETAZOLINE HCL | Walgreens Company | c126e969-56f3-47b4-a011-02ff150eccb8 | 2024-08-02 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | Rite Aid Corporation | 90e0426b-654f-4bcd-8b1d-cf56d1fc0c68 | 2024-07-27 | Warnings | M012 |
| nasal decongestant | OXYMETAZOLINE HCL | A-S Medication Solutions | 0e81a937-59e5-4869-8ffb-c758fb37230d | 2024-07-23 | Warnings | M012 |
| WesTussin DM | DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Westminster Pharmaceuticals, LLC | 68a0cd44-3fdd-430e-af1a-498d4415ab78 | 2024-07-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Lil' Drug Store Products, Inc. | edc244d6-eb0b-d3c9-e053-2a95a90a2622 | 2024-07-22 | Warnings | M012 |
| Night Time Sleep Aid | DIPHENHYDRAMINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 1f3eeb6c-4c44-4e2a-ad72-12c95e6589c9 | 2024-07-22 | Warnings | M012 |
| CareOne Childrens Allergy Relief | DIPHENHYDRAMINE HCL | American Sales Company | bb78ef2c-4f42-4e8f-b38d-f9b2965a384b | 2024-07-19 | Warnings | M012 |
| dg health allergy childrens | DIPHENHYDRAMINE HYDROCHLORIDE | Dolgencorp, LLC | 71445443-34bd-4d8c-b9c8-e7c3b8d4c832 | 2024-07-19 | Warnings | M012 |
| basic care childrens allergy relief | DIPHENHYDRAMINE HCL | Amazon.com Services LLC | 75b9ee90-ad26-433e-8b90-97441b8d1e15 | 2024-07-19 | Warnings | M012 |
| Cold and Flu Severe Day and Night | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC | 9b74dd00-8f84-4fce-b5ea-df886b595326 | 2024-07-18 | Warnings | M012 |
| Cold plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 4872dfdd-0df6-47ae-87f2-8049191cd482 | 2024-07-18 | Warnings | M012 |
| equate allergy relief | DIPHENHYDRAMINE HYDROCHLORIDE | Wal-Mart Stores Inc | b05acd16-21cb-4ee0-afa0-8f7d59166435 | 2024-07-18 | Warnings | M012 |
| Childrens Allergy | DIPHENHYDRAMINE HCL | Publix Super Markets Inc | cc6e4e26-84f5-4003-b1eb-f0e06d3e294e | 2024-07-18 | Warnings | M012 |
| childrens allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Kroger Company | 10ebc7f8-dc8a-4640-8f87-d0d073998fd5 | 2024-07-18 | 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 |