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 |
|---|---|---|---|---|---|---|
| nighttime cough dm | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | 5a45b4c2-6a15-40b4-9ac6-d1554244ec42 | 2026-07-23 | Warnings | M012 |
| DAY TIME NITE TIME INTENSE FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | 6372cbdd-a3a3-499d-91ce-53bcdb83e739 | 2026-07-23 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy | df6e522c-3e30-4aa0-8ab9-3b579c80bcad | 2026-07-22 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 0ab2ba6a-1fac-4a34-ab76-0b50b425d0ba | 2026-07-22 | Warnings | M012 |
| TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | Kenvue Brands LLC | 1c5386c1-e45d-9dcb-e063-6294a90aff07 | 2026-07-22 | Warnings | M012 |
| Allergy plus Sinus Headache | ACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MG | Shield Pharmaceuticals Corp | 772d0184-8c41-40f1-bbef-7e68692eec66 | 2026-07-22 | Warnings | M012 |
| good sense allergy | DIPHENHYDRAMINE HCL | L. Perrigo Company | bf5039a0-2109-41a2-84a9-b5167d0a93da | 2026-07-22 | Warnings | M012 |
| Congestion and Headache | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | 432c3ec4-7595-4213-94e3-ce41af91804e | 2026-07-21 | Warnings | M012 |
| SKAPEMED ORIGINAL NASAL | NAPHAZOLINE HCL 0.05% ORIGINAL NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a208a1f-f6e8-0b4a-e063-6294a90a10c8 | 2026-07-21 | Warnings | M012 |
| SERYNTH FAST RELIEF NASAL | NAPHAZOLINE HCL 0.05% FAST RELIEF NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4abdc0-aded-1b8a-e063-6394a90a9b56 | 2026-07-21 | Warnings | M012 |
| DERMFREE ORIGINAL NASAL | NAPHAZOLINE HCL0.05%ORIGINAL NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4d0c03-7d8f-76cb-e063-6394a90a938c | 2026-07-21 | Warnings | M012 |
| DERMFREE ORIGINAL NASAL | NAPHAZOLINE HCL 0.05%ORIGINAL NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4d3a2b-a4ed-c736-e063-6394a90a96df | 2026-07-21 | Warnings | M012 |
| Severe Cough and Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | 791eaac1-ddb5-40e2-9040-52dfadc30e06 | 2026-07-21 | Warnings | M012 |
| DRx Choice DAYTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Raritan Pharmaceuticals Inc. | 9ab47b10-b1ed-4ae1-94e8-09d50e952bb0 | 2026-07-21 | Warnings | M012 |
| Sleep Aid Maximum Strength | DIPHENHYDRAMINE HCL | P & L Development, LLC | 17639c3b-5d36-41f5-bd0d-da29075abd09 | 2026-07-21 | Warnings | M012 |
| NATUHEAL ORIGINAL NASAL | NAPHAZOLINE HCL 0.05% ORIGINAL NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a470b9e-c83f-fb20-e063-6294a90a2f13 | 2026-07-20 | Warnings | M012 |
| TYLENOL Cold plus Flu Multi-Symptom Liquid Gels Day | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | 1c444202-19e9-8d04-e063-6394a90a9294 | 2026-07-20 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS HONEY LEMON | DISCOUNT DRUG MART | 5565a581-e2b5-81a5-e063-6394a90af409 | 2026-07-20 | Warnings | M012 |
| Best Choice Maximum Strength | OXYMETAZOLINE HYDROCHLORIDE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 40e0b17a-5704-4203-8f0a-11b2fcf81f8f | 2026-07-17 | Warnings | M012 |
| Equate Daytime Vapor Ice Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | WALMART INC. | ee1ef41d-b8be-42f3-9918-ccf1c0a80241 | 2026-07-17 | 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 |