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
- 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 |
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 |
|---|---|---|---|---|---|---|
| Sorbutuss NR | SORBUTUSS | Dextrum Laboratories Inc. | 304f1d5a-218c-51ae-e054-00144ff88e88 | 2025-12-26 | Warnings | M012 |
| caring mill Cough drops CHERRY | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 274a28aa-00e9-8b9d-e063-6394a90ace2a | 2025-12-26 | Warnings | M012 |
| Creamy Strawberry Flavor Cough Drop | CREAMY STRAWBERRY FLAVOR COUGH DROP WITH MENTHOL AND PECTIN | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2749b83a-ea4f-d8ca-e063-6394a90a69b7 | 2025-12-26 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS CHERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f4a026-c4d2-2645-e063-6294a90aac58 | 2025-12-26 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 274a13b5-6fcb-70ed-e063-6394a90a7fb3 | 2025-12-26 | Warnings | M012 |
| Honey Lemon Flavor Cough Drop | HONEY LEMON FLAVOR COUGH DROP | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 274a4802-7c02-ccce-e063-6394a90ad71d | 2025-12-26 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS HONEY LEMON | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2749f353-9286-15b9-e063-6394a90a7693 | 2025-12-26 | Warnings | M012 |
| Leader Cough Drops Vanilla Honey | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 26a93c2c-a663-e3d1-e063-6394a90ad859 | 2025-12-26 | Warnings | M012 |
| Nite-Time COLD/FLU Medicine | ACETAMINOPHEN | AptaPharma Inc. | 344440bc-d810-4296-93ec-e6ae6673856b | 2025-12-26 | Warnings | M012 |
| Nite-Time COLD/FLU Medicine Cherry | ACETAMINOPHEN | AptaPharma Inc. | 87c2b823-ed88-44f3-8f6a-df30430b40f3 | 2025-12-26 | Warnings | M012 |
| TUSSIN CF | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | AptaPharma Inc. | c005c6cf-7891-463e-b65d-1129ad4bf6ec | 2025-12-26 | Warnings | M012 |
| Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | AptaPharma Inc. | b2cef61f-ab54-4a20-a7f7-6d3da4754e8b | 2025-12-26 | Warnings | M012 |
| CHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVOR | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | AptaPharma Inc. | 9ae6fe74-80cd-482a-b3b9-3acafd6708ec | 2025-12-26 | Warnings | M012 |
| Tussin Expectorant | GUAIFENESIN | AptaPharma, Inc. | ca8fa216-09c1-42b2-a95b-fa3d0f13363c | 2025-12-26 | Warnings | M012 |
| Gencare DayTime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Pioneer Life Sciences, LLC | a9875dc9-6a27-413c-a2c7-68a86483ffc1 | 2025-12-26 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 3b7e0ee7-4dda-4bbe-842c-6cbbc208acd5 | 2025-12-26 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 0d604fc6-7bb9-4f7c-99cd-fdae4df4bb6f | 2025-12-26 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MG | Pioneer Life Sciences, LLC | 3ce0f096-906e-47eb-8061-0ac1e9d8ea55 | 2025-12-26 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 1194c338-e115-4105-93d8-9ab833c43193 | 2025-12-26 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 9c9e558d-d991-4a2e-aa13-37c0b08071e6 | 2025-12-26 | 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 |