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 | TOP CARE (Topco Associates LLC) | 027d7eff-6c83-40f1-9716-231637cdbeba | 2025-06-12 | Warnings | M010 |
| Nighttime Sleep Aid maximum strength | DIPHENHYDRAMINE HCL | Cardinal Health (Leader) 70000 | 546e4fda-6eb2-4358-840e-e2473bf7f352 | 2025-06-03 | Warnings | M010 |
| Simply Sleep | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 37c606b0-04d5-49f0-886a-3ee2c9b0e9cc | 2025-06-02 | Warnings | M010 |
| Sleep Aid Maximum Strength | DIPHENHYDRAMINE HCL | WinCo Foods, LLC | e9bc5a16-b1fc-4585-8f3b-30ccf4300492 | 2025-05-30 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | Care One (Retail Business Services, LLC.) | 51e633a8-5bfc-4ff9-816f-3bc22b8a5c4c | 2025-05-23 | Warnings | M010 |
| Nighttime Sleep Aid Maximum Strength | DIPHENHYDRAMINE HCL | Care One (Retail Business Services, LLC.) | 536cd7d6-a470-4614-89c8-6c3ada582a90 | 2025-05-23 | Warnings | M010 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | BI-MART | 2914504a-ed42-4168-9e5c-f49407ed5a30 | 2025-05-20 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | Cardinal Health (Leader) 70000 | 133d6f38-9de7-4104-8175-3933b263afe0 | 2025-05-16 | Warnings | M010 |
| Nighttime Sleep-aid | DIPHENHYDRAMINE HCL | NORTHEAST PHARMA | d2062094-d1b5-38ab-e053-2995a90a5670 | 2025-05-15 | Warnings | M010 |
| Nighttime Sleep-aid | DIPHENHYDRAMINE HCL | Geri-Care Pharmaceutical Corp | 0fce381f-28ef-4591-a569-c5d599a3b95f | 2025-05-14 | Warnings | M010 |
| Rest Simply | DIPHENHYDRAMINE HYDROCHLORIDE | Chain Drug Marketing Association | 54bdb6bc-622c-412a-8365-a1b1c968e13e | 2025-05-01 | Warnings | M010 |
| Diphenhydramine HCl Maximum Strength | DIPHENHYDRAMINE HCL | Bi-Mart | b89c80aa-27ae-4fce-b574-8ee64bbae275 | 2025-05-01 | Warnings | M010 |
| Sleep Aid Nighttime | DIPHENHYDRAMINE HCL | United Natural Foods, Inc. dba UNFI | 217a211e-b8bf-4119-a094-0e5e733d0b18 | 2025-04-21 | Warnings | M010 |
| Vicks PainQuil PM PAIN RELIEVER plus NIGHTTIME SLEEP-AID | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | The Procter & Gamble Manufacturing Company | 32bedbbc-b939-1bea-e063-6394a90a6934 | 2025-04-14 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 25f32a1c-0687-45e9-8142-96cf63599090 | 2025-04-03 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | FSA Store Inc. (Caring Mills) | 9d32a3a1-9528-4de4-9fd1-1d01a1ad93e9 | 2025-03-28 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | WR Group, Inc. | d28d0f6d-8029-4e31-b417-4f8f864d840e | 2025-03-28 | Warnings | M010 |
| Sleep Aid NightTime | DIPHENHYDRAMINE HCL | P & L Development, LLC | 4144b1a6-aeae-4560-a997-b07206d80350 | 2025-03-24 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Strategic Sourcing Services LLC | a512413c-639b-4846-b016-332a78b50ab7 | 2025-03-21 | Warnings | M010 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | PD-Rx Pharmaceuticals, Inc. | 1ee41c86-6767-43ca-a5bb-fc685fa662cd | 2025-03-20 | 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 |