Daytime Cold and Flu
- Product NDC
- 83324-167
- 11-digit product format
- 833240167
- Labeler code
- 83324
- Product ID
- 83324-167_5a586e44-70db-4b17-9ae1-4b9bb77d9fa4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen Dextromethorphan HBr Phenylephrine HCl
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- QUALITY CHOICE (Chain Drug Marketing Association)
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-07-31
- 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
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
- Daytime Cold and Flu
- 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 |
|---|---|
| 4754363d-e163-42e0-a65d-1c4bac24f6c9 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83324-167-12 | Daytime Cold and Flu | 355 mL in 1 BOTTLE, PLASTIC | LIQUID | 355 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 83324-167 | DAYTIME COLD AND FLU (ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] | 1 | Current NDC, 1 package rows | 20240731_4754363d-e163-42e0-a65d-1c4bac24f6c9.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 |
|---|---|---|---|---|---|---|
| severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreen Company | 7dc3941a-e5f8-4caa-bae5-6a0d075295cb | 2024-11-01 | Warnings | M012 |
| DoloMax Cold Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | BENARD INDUSTRIES INC | 520aee75-8b9a-4dcc-8970-75e122640e91 | 2024-10-31 | Warnings | M012 |
| Good Sense Nasal | OXYMETAZOLINE HYDROCHLORIDE | A-S Medication Solutions | b6fbc0ba-7e88-4ab9-b0fa-1e1e8f9132fe | 2024-10-31 | Warnings | M012 |
| CareOne Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | American Sales Company | 819d5c82-0240-4013-9904-c335bd65d03e | 2024-10-30 | Warnings | M012 |
| Signature Care Nighttime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Safeway | 9a0ad5d5-8fd9-468d-be2c-87c14d08b934 | 2024-10-30 | Warnings | M012 |
| Good Sense Severe NightTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | L. Perrigo Company | f2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd2 | 2024-10-30 | Warnings | M012 |
| dg health cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Dolgencorp, LLC | 81f3ac36-9bae-4f42-92a0-8a2e4bbd0984 | 2024-10-30 | Warnings | M012 |
| severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Rite Aid Corporation | 9a71e8eb-4195-4694-bf3e-44f691ff2cef | 2024-10-30 | Warnings | M012 |
| nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | H E B | fe4a95d2-6fb3-43fe-baec-6f22d1965323 | 2024-10-30 | Warnings | M012 |
| NightTime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Kroger Company | 2c9ef0d7-3d5b-494a-8f06-9dd42110d78a | 2024-10-30 | Warnings | M012 |
| Severe Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy | d40d6fd1-3f84-40ae-ab7e-04569eb41617 | 2024-10-30 | Warnings | M012 |
| equaline nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 4e0c6ad6-81ef-4b0e-b2eb-44256faf7358 | 2024-10-30 | Warnings | M012 |
| GOOD REMEDIES Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 24fbe2c0-7749-4c8a-e063-6394a90a7c6e | 2024-10-30 | Warnings | M012 |
| basic care nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 130e68d1-9048-49c1-beee-490eecaed2d9 | 2024-10-30 | Warnings | M012 |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreen Company | 02f3e739-3153-412f-b2cd-6f01dcd5875b | 2024-10-30 | Warnings | M012 |
| HealthWise Medicated Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Veridian Healthcare | 25a19d3e-37b3-50d5-e063-6394a90a97d1 | 2024-10-29 | Warnings | M012 |
| Antigrip Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Pharmadel LLC | 25a23a03-6110-f595-e063-6394a90a70fe | 2024-10-29 | Warnings | M012 |
| Antigrip Cough and Cold | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Pharmadel LLC | 25a23e5e-302a-7b7f-e063-6294a90a0463 | 2024-10-29 | Warnings | M012 |
| Antigrip Extra Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Pharmadel LLC | 25a26adf-fd90-bf57-e063-6294a90a4073 | 2024-10-29 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | BOSTON NUTRACEUTICAL PRODUCTION, S.L | e82dac83-2910-44dc-e053-2995a90a38e1 | 2024-10-29 | 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 | 4754363d-e163-42e0-a65d-1c4bac24f6c9 | 2 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 4754363d-e163-42e0-a65d-1c4bac24f6c9 | 2 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 4754363d-e163-42e0-a65d-1c4bac24f6c9 | 2 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 4754363d-e163-42e0-a65d-1c4bac24f6c9 | 2 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | 4754363d-e163-42e0-a65d-1c4bac24f6c9 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83324-167-12 | 83324016712 | 355 mL in 1 BOTTLE, PLASTIC (83324-167-12) | 355 ml | 2024-07-31 | No | No | Current |