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 |
|---|---|---|---|---|---|---|
| Mentholatum No Mess Vaporizing Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | The Mentholatum Company | f4675bc1-01cc-4a33-a3bf-bfc99230fe32 | 2024-12-17 | Warnings | M012 |
| Mentholatum Cherry Vaporizing Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | The Mentholatum Company | de01225a-eabb-4972-bf3a-3e5a0e44abef | 2024-12-17 | Warnings | M012 |
| Rite Aid Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Rite Aid Corporation | 198a666a-3f34-4e4f-89e8-ec7f412f00af | 2024-12-17 | Warnings | M012 |
| Equate Childrens Vaporizing | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Wal-Mart Stores Inc | 372e66a6-1f1f-4aa3-a2ed-d215fafee9b9 | 2024-12-17 | Warnings | M012 |
| Caring Mill Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | FSA Store Inc. | caa83419-c332-4b92-b151-22da2fa85289 | 2024-12-17 | Warnings | M012 |
| Always Save Chest Congestion Relief GUAF | GUAIFENESIN | Valu Merch | 9d81d88b-2db9-4891-942b-fecb1be961dd | 2024-12-17 | Warnings | M012 |
| Kroger EXTRA STRENGTH Acetaminophen PM Caplet | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | The Kroger Co. | 24a75ffa-c2a7-71a9-e063-6394a90a0e25 | 2024-12-17 | Warnings | M012 |
| Allergy 36ct, Caseys 4good | DIPHENHYDRAMINE HCL 25MG | Lil' Drug Store Products, Inc. | 04b78b23-424d-9762-e063-6394a90a52e3 | 2024-12-16 | Warnings | M012 |
| Sinus Relief, Caseys 4good | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATED | Lil' Drug Store Products, Inc. | 033837c0-fa68-a38d-e063-6394a90a9832 | 2024-12-16 | Warnings | M012 |
| DayQuil Severe plus VapoCOOL Cold and Flu, Travel BASIX | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | cfab9b80-0580-4482-b6e3-0aab875b5797 | 2024-12-16 | Warnings | M012 |
| Allergy Relief, 24-7 Lift by 7-Eleven | DIPHENHYDRAMINE HCL 25MG | Lil' Drug Store products, Inc. | 04c9db9a-95ef-3a48-e063-6294a90a4e8e | 2024-12-16 | Warnings | M012 |
| Cold and Flu Daytime Severe, 24/7 Life | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLET | Lil' Drug Store Products, Inc. | 05cc7185-d49d-82a3-e063-6294a90a568e | 2024-12-16 | Warnings | M012 |
| Cold and Flu Nighttime Severe, 24-7 Life | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Lil' Drug Store products, Inc. | 05d0410f-164e-e7ee-e063-6394a90a2aaa | 2024-12-16 | Warnings | M012 |
| tussin dm max daytime nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFESESIN | CVS Pharmacy | 6feaf29e-de06-4c94-912c-a76ea2cbd8c1 | 2024-12-16 | Warnings | M012 |
| Leader Childrens Multi Symptom Cold | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CARDINAL HEALTH 110, LLC. DBA LEADER | 169ff9cf-fcf5-46a6-b460-259421f2ec07 | 2024-12-16 | Warnings | M012 |
| Childrens Mucus and Cough Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN | CARDINAL HEALTH 110, LLC. DBA LEADER | 125eeb3d-0ee2-45bb-81c0-4ca699979886 | 2024-12-16 | Warnings | M012 |
| Dextromethorphan HBr 15 mg Liquid Gels | DEXTROMETHORPHAN HBR | RUGBY LABORATORIES | cf3cc387-6642-43fd-999d-688fdaf65d4f | 2024-12-14 | Warnings | M012 |
| Allergy Relief Dye-Free Softgel | DIPHENHYDRAMINE HYDROCHLORIDE | CVS PHARMACY, INC | 60b1bb79-3ed1-438b-a27f-f7fbc108d114 | 2024-12-14 | Warnings | M012 |
| Rycontuss Cherry Flavor | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Okendpharma, Inc. | c91798fa-48ab-47a0-92da-4d44c2aafde0 | 2024-12-13 | Warnings | M012 |
| Mentholatum Lavender Vaporizing Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | The Mentholatum Company | 6f208c05-617d-492a-a016-e9d6be3c971f | 2024-12-13 | 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 |