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 | DIPHENHYDRAMINE HCL | AMERISOURCE BERGEN | 16b2edd2-c16b-5713-e063-6394a90acf46 | 2025-12-01 | Warnings | M010 |
| Nighttime Sleep-Aid | DIPHENHYDRAMINE HCL | VALU MERCHANDISERS COMPANY | 08a38cd2-04ae-1ef9-e063-6294a90a8868 | 2025-12-01 | Warnings | M010 |
| Nighttime Sleep-Aid | DIPHENHYDRAMINE HCL | KROGER COMPANY | 0f2c1c6a-29bc-e4a8-e063-6394a90a28cb | 2025-12-01 | Warnings | M010 |
| Nighttime Sleep-Aid | DIPHENHYDRAMINE HCL | Whole Foods Market, INC. | 35acf7d9-e567-996d-e063-6394a90a1cf6 | 2025-12-01 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | WALGREEN COMPANY | 048cfa3a-4519-400d-a5ab-ce05c9cc4ec8 | 2025-11-26 | Warnings | M010 |
| Sleep Aid Nighttime | DIPHENHYDRAMINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | fe58ce40-ae88-4dc5-9486-e67041f6d852 | 2025-11-26 | Warnings | M010 |
| nighttime sleep aid | DIPHENHYDRAMINE HYDROCHLORIDE | H E B | b72c47a3-cae3-4b98-ae85-e1313b6fd501 | 2025-11-25 | Warnings | M010 |
| Nighttime Wal Flu Severe Cold and Cough | ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE | WALGREEN CO. | e88f7777-9987-4e3c-a3d5-3da60f190bfd | 2025-11-25 | Warnings | M010 |
| Overnight Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | WALGREENS CO | 807e8ace-2901-4c5f-96dc-04c755484b95 | 2025-11-25 | Warnings | M010 |
| Sleep | DIPHENHYDRAMINE HCL | Salado Sales, Inc. | 837c02dd-971b-4451-98d8-9c438c9db696 | 2025-11-24 | Warnings | M010 |
| Nighttime SleepAid | DIPHENHYDRAMINE HYDROCHLORIDE | AMERIFOODS TRADING COMPANY | 3802d57e-7943-c0c2-e063-6394a90a7580 | 2025-11-20 | Warnings | M010 |
| Sleep-Aid Nighttime | DIPHENHYDRAMINE HCL | CVS PHARMACY | 6bd1ad2e-8f47-412d-8620-b149ad90c292 | 2025-11-17 | Warnings | M010 |
| Nighttime Sleep-Aid | DIPHENHYDRAMINE HCL | Rite Aid Corporation | f8d50b4e-735d-4d91-a18d-be3537e46e99 | 2025-11-15 | Warnings | M010 |
| SLEEP AID | DIPHENHYDRAMINE HYDROCHLORIDE | Company name: Topco Associates, LLC | 7aec7b1b-39dc-4e99-9f92-d45af0a4a6ec | 2025-10-31 | Warnings | M010 |
| NIGHTTIME SLEEP AID | DIPHENHYDRAMINE HYDROCHLORIDE | WALGREEN COMPANY | e96ec4d4-53b9-4636-a58c-1a5923a021ad | 2025-10-31 | Warnings | M010 |
| GOODNOW SLEEP AID | DIPHENHYDRAMINE HCL | Gobrands, Inc | 7d821b7d-6a31-4ff7-b587-51907ba62658 | 2025-10-29 | Warnings | M010 |
| Meijer Nighttime Sleep-aid Berry Flavor | DIPHENHYDRAMINE HYDROCHLORIDE | MEIJER DISTRIBUTION INC | c7258241-2966-4876-918b-84bbf50ec4bc | 2025-10-24 | Warnings | M010 |
| Meijer Nighttime Sleep Aid Non Habit Forming | DIPHENHYDRAMINE HYDROCHLORIDE | MEIJER DISTRIBUTION INC | fd476bfa-3e2e-470c-9180-19aa43e4af24 | 2025-10-24 | Warnings | M010 |
| Sominex | DIPHENHYDRAMINE HYDROCHLORIDE | Medtech Products Inc. | f7858ecf-8498-4465-85d8-3e7814737573 | 2025-10-23 | Warnings | M010 |
| Sominex Max | DIPHENHYDRAMINE HCL | Medtech Products Inc. | e8f6991f-c47a-4d12-934b-04fdf092dac3 | 2025-10-23 | 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 |