Cold and Flu Relief
- Product NDC
- 67091-258
- 11-digit product format
- 670910258
- Labeler code
- 67091
- Product ID
- 67091-258_8d3b6a00-5d66-4cc1-a062-62ffc6369248
- 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
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 |
|---|---|
| 5791c1c7-f614-4940-a45a-6291742e1e22 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67091-258-23 | Cold and Flu ReliefMulti Symptom Nighttime | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 | 7 | |
| 67091-258-54 | Cold and Flu ReliefMulti Symptom Nighttime | 355 mL in 1 BOTTLE, PLASTIC | LIQUID | 355 | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67091-258 | COLD AND FLU RELIEF MULTI SYMPTOM NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [WINCO FOODS, LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240919_5791c1c7-f614-4940-a45a-6291742e1e22.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 |
|---|---|---|---|---|---|---|
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 1695e7ea-2f83-4d3a-980e-c91be6c1f2a5 | 2025-12-25 | Warnings | M012 |
| GUAIFENESIN | GUAIFENESIN | Pharbest Pharmaceuticals, Inc. | 0bf70fb4-d3c8-476d-b864-4eadc697a7d8 | 2025-12-24 | Warnings | M012 |
| PHARBINEX-DM | GUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MG | Pharbest Pharmaceuticals, Inc. | 8d71db43-da87-45ee-aa4a-7e870bc5016d | 2025-12-24 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Safeway, Inc. | 764bcc58-bc5f-4ee6-82b7-cb0ed5baf3be | 2025-12-23 | Warnings | M012 |
| Tussin | GUAIFENESIN | Discount Drug Mart | 14de3d6d-4eb0-42cf-8941-cb42b3dd5c71 | 2025-12-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Pioneer Life Sciences, LLC | c8dcba06-a461-4af5-a120-666a63f06ac4 | 2025-12-23 | Warnings | M012 |
| SAFETUSSIN MAX STRENGTH MS Cough, Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN | KRAMER LABORATORIES | 920bde5f-4079-45de-aa59-24b00e50cb56 | 2025-12-23 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd | 46996bbf-948c-0aba-e063-6394a90a09e3 | 2025-12-23 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Lil' Drug Store Products, Inc. | 1d2e2a5a-099b-41b3-82bd-5bf704377f78 | 2025-12-23 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | 5b493ed7-9044-4841-9935-236d0bdc71a9 | 2025-12-23 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | 77a7ff9a-a414-4053-8d8d-369907d4380d | 2025-12-23 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Lil' Drug Store Products, Inc. | 8f320235-f243-4211-b99c-18526e686548 | 2025-12-23 | Warnings | M012 |
| Circle K Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | b6a46498-d9a8-4da2-9283-57d135f305a5 | 2025-12-23 | Warnings | M012 |
| Circle K Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Lil' Drug Store Products, Inc. | 7c5faec2-28c6-4c15-a268-d8b578140b74 | 2025-12-23 | Warnings | M012 |
| Sugar Free Honey Lemon Cough Drops | MENTHOL | Walmart | 67650b94-adbb-87fb-e053-2a91aa0a87e6 | 2025-12-23 | Warnings | M012 |
| Equate Benz-Dex Cough and Throat Lozenges | BENZOCAINE | Walmart | c0a6cb7f-a247-e610-e053-2a95a90a4199 | 2025-12-23 | Warnings | M012 |
| Equate Honey Lemon Cough Drops | MENTHOL | WalMart | 0028be18-5162-ff51-e063-6294a90ae517 | 2025-12-23 | Warnings | M012 |
| Equate SF Menthol Cough Drops | MENTHOL | WalMart | 003a229c-b014-e9f3-e063-6294a90aa5ed | 2025-12-23 | Warnings | M012 |
| Equate Menthol Cough Drops | MENTHOL | Walmart | 124e6968-f59c-39d4-e063-6294a90a66d4 | 2025-12-23 | Warnings | M012 |
| Equate Severe Menthol Throat Drop | MENTHOL | Walmart | 125f3f5a-52aa-e398-e063-6394a90a0012 | 2025-12-23 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 5791c1c7-f614-4940-a45a-6291742e1e22 | 7 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 5791c1c7-f614-4940-a45a-6291742e1e22 | 7 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 5791c1c7-f614-4940-a45a-6291742e1e22 | 7 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 5791c1c7-f614-4940-a45a-6291742e1e22 | 7 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 5791c1c7-f614-4940-a45a-6291742e1e22 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 67091-258-23 | 67091025823 | 237 mL in 1 BOTTLE, PLASTIC (67091-258-23) | 237 ml | 2014-12-31 | 0000-00-00 | No | No | Current |
| 67091-258-54 | 67091025854 | 355 mL in 1 BOTTLE, PLASTIC (67091-258-54) | 355 ml | 2014-12-31 | 0000-00-00 | No | No | Current |