CVS NightTime Cold
- Product NDC
- 51316-641
- 11-digit product format
- 513160641
- Labeler code
- 51316
- Product ID
- 51316-641_418a3592-639f-47ec-8717-87fe77e0d837
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- CVS PHARMACY
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-01-09
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], 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], 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
- CVS NightTime Cold
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1431245 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0f0cc40d-7939-4d4d-a931-b4de4070fea1 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-641-12 | CVS NightTime Cold | 354 mL in 1 BOTTLE, PLASTIC | SOLUTION | 354 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51316-641 | CVS NIGHTTIME COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [CVS PHARMACY] | 5 | Current NDC, 1 package rows | 20240817_0f0cc40d-7939-4d4d-a931-b4de4070fea1.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 |
|---|---|---|---|---|---|---|
| Nighttime sleep aid Maximum Strength | DIPHENHYDRAMINE HYDROCHLORIDE | Best Choice (Valu Merchandisers Company) | 40e73317-5126-4961-8f28-60899ffbec5a | 2024-02-20 | Warnings | M010 |
| Nighttime sleep aid Maximum Strength | DIPHENHYDRAMINE HYDROCHLORIDE | Best Choice (Valu Merchandisers Company) | 2424fb95-06e2-49e7-aea0-7797a37aef4d | 2024-02-20 | Warnings | M010 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | CVS Pharmacy, Inc | f5b609e1-e63b-2e3b-e053-2995a90a76b9 | 2024-02-12 | Warnings | M010 |
| Kroger Nighttime Sleep Aid CAPLET | DIPHENHYDRAMINE HYDROCHLORIDE | The Kroger Co. | f0f3f58d-9457-4697-98e6-ef52d350cf67 | 2024-01-29 | Warnings | M010 |
| Nighttime Sleep Aid | NIGHTTIME SLEEP AID | Allegiant Health | 88feea1d-c961-45e9-b9a6-1418b970aaba | 2024-01-16 | Warnings | M010 |
| Sleep-Aid Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Cardinal Health 110, LLC. DBA Leader | 4283558d-62df-4297-bc85-a4e06681a920 | 2024-01-11 | Warnings | M010 |
| Nighttime Sleep-Aid | DIPHENHYDRAMINE HYDROCHLORIDE | DeMoulas Market Basket | d3f35102-94ed-4da0-9c29-312e5468fa05 | 2023-12-29 | Warnings | M010 |
| nighttime sleep-aid | DIPHENHYDRAMINE HCL | Bionpharma Inc. | c0074c77-287e-6c26-e053-2995a90a4d31 | 2023-12-26 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYRAMINE HYDROCHLORIDE | TARGET CORPORATION | fac83dad-f6fd-3316-e053-6394a90a99aa | 2023-12-21 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENYDRAMINE HYDROCHLORIDE | TARGET CORPORATION | fc7ed67f-bac9-f9ed-e053-6294a90ad9a1 | 2023-12-16 | Warnings | M010 |
| Sleep-Aid, Circle K | DIPHENHYDRAMINE HCL CAPLET, 25MG | Lil' Drug Store Products, Inc. | d3ad24c4-44ba-6451-e053-2a95a90a1339 | 2023-12-14 | Warnings | M010 |
| Nighttime Sleep-Aid | DIPHENHYDRAMINE HCL | VALU MERCHANDISERS COMPANY | fed2f7ae-2829-f967-e053-6294a90adc0a | 2023-10-12 | Warnings | M010 |
| Sleep Aid | SLEEP AID | Better Living Brands LLC | 2b730fa5-47f9-468d-86ed-0d49d9cd8dc4 | 2023-07-06 | Warnings | M010 |
| Diphenhydramine HCl 25mg | SLEEP AID | Allegiant Health | 2890e4ba-d642-437d-8a86-24996a74e027 | 2021-11-23 | Warnings | M010 |
| Sleep Aid | SLEEP AID | Allegiant Health | 9a0b347e-5719-42f3-9050-df5165495e88 | 2021-10-14 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Allegiant Health | ec57db48-0f3a-4b12-8633-b45a4366c269 | 2020-11-06 | Warnings | M010 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | 0f0cc40d-7939-4d4d-a931-b4de4070fea1 | 6 |
| 1431245 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 0f0cc40d-7939-4d4d-a931-b4de4070fea1 | 6 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 0f0cc40d-7939-4d4d-a931-b4de4070fea1 | 6 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 0f0cc40d-7939-4d4d-a931-b4de4070fea1 | 6 |
| 1431245 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | 0f0cc40d-7939-4d4d-a931-b4de4070fea1 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51316-641-12 | 51316064112 | 354 mL in 1 BOTTLE, PLASTIC (51316-641-12) | 354 ml | 2023-01-09 | No | No | Current |