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 |
|---|---|---|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | CVS Pharmacy, Inc. | 6e0f7ab7-eb1e-9a19-e053-2991aa0a6d1f | 2024-12-02 | Warnings | M010 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | CVS Pharmacy, Inc. | 6dd802ec-fc26-3913-e053-2a91aa0ad05d | 2024-12-02 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | PUBLIX SUPER MARKETS INC | 236ff457-0ec1-9c49-e063-6394a90a707a | 2024-11-26 | Warnings | M010 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 50d74111-6d1b-4681-a264-f7e550320259 | 2024-11-25 | Warnings | M010 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | efb05387-72c0-4643-8541-b7990c202ce6 | 2024-11-25 | Warnings | M010 |
| Nighttime Sleep Aid, 24-7 Life BY 7-ELEVEN, 6oz | DIPHENHYDRAMINE HCL SOLUTION | Lil' Drug Store Products, Inc. | 2781fc28-8a7d-d0fa-e063-6394a90ac793 | 2024-11-22 | Warnings | M010 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 7830ce18-908a-4f86-a238-8c31cfe47ce6 | 2024-11-21 | Warnings | M010 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | f8de6605-4a0a-492d-beb5-f414ce8bfb0e | 2024-11-20 | Warnings | M010 |
| Nighttime SLEEP AID | DIPHENHYDRAMINE HCL 50MG | PuraCap Pharmaceutical LLC | 272a7138-2a97-8e62-e063-6394a90a1af1 | 2024-11-18 | Warnings | M010 |
| ZzzQuil | DIPHENHYDRAMINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | 0b2777be-85d4-443d-b65f-6750e0ba97ba | 2024-11-18 | Warnings | M010 |
| RiteAid Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHEN | RITE AID CORPORATION | 54fc0893-9702-4849-a702-3e84dc9ead03 | 2024-10-30 | Warnings | M010 |
| Rite Aid Nighttime Sleep Aid Non Habit Forming | DIPHENHYDRAMINE HYDROCHLORIDE | RITE AID CORPORATION | 59ba6824-fa6c-4b3f-9f1f-ea194766c8a1 | 2024-10-30 | Warnings | M010 |
| GOOD REMEDIES Nighttime Sleep Aid Caplets | DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 24fba735-cedf-9d15-e063-6394a90af873 | 2024-10-29 | Warnings | M010 |
| Premier Value Nighttime Sleep-Aid Liquid Sleep-Aid | DIPHENHYDRAMINE HYDROCHLORIDE | Chain Drug Consortium | 6d24b6e1-7959-47c6-a09b-c7e00a437495 | 2024-10-28 | Warnings | M010 |
| Nytol | DIPHENHYDRAMINE HCL | Medtech Products Inc. | c81d018a-0170-4396-81e9-2e13a53f868a | 2024-10-25 | Warnings | M010 |
| Rest Simply | DIPHENHYDRAMINE HYDROCHLORIDE | Marc Glassman, Inc. | 2ab3852d-53a4-411b-a9ad-3ef88ab3ee87 | 2024-10-23 | Warnings | M010 |
| nitetime sleep aid | DIPHENHYDRAMINE HCL | Meijer Distribution Inc | 43184abd-2525-402a-a388-85af2e5c13ad | 2024-10-17 | Warnings | M010 |
| Good Sense Sleep Time | DIPHENHYDRAMINE HCL | L. Perrigo Company | 164200a9-b1f8-44c9-8598-a7dff5020e9d | 2024-10-16 | Warnings | M010 |
| Equaline Night Time Sleep Aid | DIPHENHYDRAMINE HCL | United Natural Foods, Inc. dba UNFI | 6d34ee3e-3d61-481e-98d6-acfa066e4247 | 2024-10-16 | Warnings | M010 |
| basic care nighttime sleep aid | DIPHENHYDRAMINE HCL | Amazon.com Services LLC | 027de5ea-5c07-4960-8a98-8cf2c0e54a92 | 2024-10-16 | 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 |