Daytime Cold and Flu
- Product NDC
- 51316-421
- 11-digit product format
- 513160421
- Labeler code
- 51316
- Product ID
- 51316-421_70d0e6d8-8206-4daa-b704-765e6d7f67a4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- CVS PHARMACY, INC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-05-31
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 325; 10 mg/15mL; mg/15mL
- Pharmacologic classes
- 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
- 2026-12-31
- 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
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/15mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2604561 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-421-12 | Daytime Cold and Flu | 355 mL in 1 BOTTLE, PLASTIC | LIQUID | 355 | 5 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Childrens Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night Time | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 9aca1a68-893c-4770-8a48-d5d678058253 | 2026-05-27 | Warnings | M012 |
| Childrens Delsym Cough Plus Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | d26b5143-aa07-4114-a6ba-4f503aadd46f | 2026-05-27 | Warnings | M012 |
| Goodmeds Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | 37533188-8c91-428b-a796-c5afd9e4959f | 2026-05-27 | Warnings | M012 |
| Delsym Cough Plus Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | 8252cdec-b668-4450-b045-e093479ab542 | 2026-05-27 | Warnings | M012 |
| Delsym Nighttime Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 27f9d2db-38ce-41d2-8f1a-0eb171600274 | 2026-05-27 | Warnings | M012 |
| Delsym Cough Plus Sore Throat | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | b37b786e-0cce-419d-94ed-3b64a1eb1201 | 2026-05-27 | Warnings | M012 |
| Delsym Cough | DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | a43d59f9-3a6c-4a7c-b98d-b86d6035f716 | 2026-05-27 | Warnings | M012 |
| Cold and Flu Relief Severe Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 5700ef26-ffa6-480a-bf36-bd5111799e9b | 2026-05-27 | Warnings | M012 |
| Air Power | GUAIFENESIN | Schwabe North America, Inc | 5cdefc7a-6242-4681-88a3-04422a1d48d3 | 2026-05-27 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | WALMART INC. | adb658c8-db8d-4db6-80c8-e0f2de88a2de | 2026-05-27 | Warnings | M012 |
| Daytime Cold and Flu Non Drowsy | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS Pharmacy | c71427d4-707f-411f-8bd4-133517a9992b | 2026-05-26 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | CVS PHARMACY, INC | 643e929d-9e62-4260-91ee-e88a184dd7cd | 2026-05-26 | Warnings | M012 |
| TopCare Day Time Nite Time Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Topco Associates LLC | c00ff684-acaf-4fbe-bc74-7e48751b927d | 2026-05-26 | Warnings | M012 |
| Goodmeds Non-Drowsy Nasal Decongestant PE | PHENYLEPHRINE | Cabinet Health P.B.C. | 4e75da23-35f2-431c-92cb-c2c4cb3f09f1 | 2026-05-26 | Warnings | M012 |
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | CVS Pharmacy | 13492631-d5de-4562-a201-664f7d3591de | 2026-05-26 | Warnings | M012 |
| Sinufrin Decongestant | NASAL CONGESTION RELIEF | NeilMed Pharmaceuticals Inc | 52a2e5f9-e0a2-02f7-e063-6294a90a3ae9 | 2026-05-25 | Warnings | M012 |
| Cough Suppressant Adult | DEXTROMETHORPHAN HYDROBROMIDE | Rugby Laboratories | 47b713bd-4c1e-f44a-e063-6294a90a63d3 | 2026-05-25 | Warnings | M012 |
| ClorRelief | CHLORPHENIRAMINE MALEATE | FERRER MEDICAL INNOVATIONS LLC | db729011-f72f-5911-e053-2a95a90a68bf | 2026-05-22 | Warnings | M012 |
| Childrens Dye Free Allergy Relief | DIPHENHYDRAMINE HCL | Rite Aid Corporation | 74ff4f0d-7952-4b74-b1b2-5a2beab91f7c | 2026-05-22 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | WALMART INC. | 321430a5-11c9-4d33-8638-5149f601f1bb | 2026-05-22 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2604561 | acetaminophen 650 MG / dextromethorphan HBr 20 MG in 30 mL Oral Solution | PSN | 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | 5 |
| 2604561 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution | SCD | 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | 5 |
| 2604561 | acetaminophen 325 MG / dextromethorphan HBr 10 MG per 15 ML Oral Solution | SY | 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | 5 |
| 2604561 | acetaminophen 650 MG / dextromethorphan HBr 20 MG per 30 ML Oral Solution | SY | 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | 5 |
| 2604561 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution | SY | 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51316-421-12 | 51316042112 | 355 mL in 1 BOTTLE, PLASTIC (51316-421-12) | 355 ml | 2024-05-31 | No | No | Current |