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 | United Natural Foods, Inc. dba UNFI | 6c9b7576-428a-4884-8331-bb312c9046bd | 2026-04-01 | Warnings | M010 |
| Calmco Sleep Aid | DIPHENHYDRAMINE HCL | CalmCo LLC | 471d4c70-813a-19de-e063-6394a90aeb25 | 2026-03-31 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | The Kroger Co. | 0db543bb-c6c3-4370-a70c-e1652781fd7d | 2026-03-25 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL 50MG | Grocery Outlet | 57a751e9-d8b6-4527-8537-bc4be718f5ec | 2026-03-17 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Walgreen Company | df7a43d1-83a7-4e86-baef-4b9d1ebf0dbb | 2026-03-16 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | Grocery Outlet, Inc. | 4454df6a-931f-3f03-e063-6294a90afe73 | 2026-03-14 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Cardinal Health 110, LLC. DBA Leader | 1d73e966-aa4a-40a0-b42a-fda8e500756e | 2026-03-13 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Walgreens | ea1b5ec1-3c8e-437d-8e37-f38ab66d9f78 | 2026-03-13 | Warnings | M010 |
| ZzzQuil Nighttime Sleep-Aid | DIPHENHYDRAMINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | ad4babdb-d98d-420e-b8b0-9a5368c89a44 | 2026-03-12 | Warnings | M010 |
| Sleep Aid Nighttime | DIPHENHYDRAMINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 8dc17b5d-1cf7-44d2-9e78-d2c6952c7d20 | 2026-03-11 | Warnings | M010 |
| sleep aid | DIPHENHYDRAMINE HCL | Rite Aid Corporation | bdfd7d87-2b54-4c29-ba69-aad0fab682e7 | 2026-03-11 | Warnings | M010 |
| ZzzQuil Nighttime Sleep-Aid | DIPHENHYDRAMINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | 1d608c94-1651-f318-e063-6294a90aa11e | 2026-03-05 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Wal-Mart Stores Inc | 5ef35ab9-b6e8-4c88-a623-35ac9d6bd359 | 2026-03-05 | Warnings | M010 |
| ZzzQuil Nighttime Sleep-Aid | DIPHENHYDRAMINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | e441c952-cd48-4159-ada2-271ca7541600 | 2026-02-20 | Warnings | M010 |
| Vicks ZzzQuil NIGHT PAIN NIGHTTIME SLEEP-AID PAIN RELIEVER | DIPHENHYDRAMINE HCL, ACETAMINOPHEN | The Procter & Gamble Manufacturing Company | 065d760b-70a5-3e26-e063-6394a90a48cd | 2026-02-20 | Warnings | M010 |
| Sleep-Aid | DIPHENHYDRAMINE HCL | WALMART INC. (see also Equate) | 84c37f4d-60f6-490e-ba8b-47d1257fa6f8 | 2026-02-13 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | P & L Development, LLC | 59c063ad-6ea3-4f1d-a20e-5e5e062a9098 | 2026-02-10 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | WinCo Foods, LLC | f446e56f-c664-4092-8712-aa3f204172f8 | 2026-02-02 | Warnings | M010 |
| Sleep Aid Night Time | DIPHENHYDRAMINE HCL | DOLGENCORP, LLC | d805fab3-9dca-497f-bdc6-c8a7b1736109 | 2026-01-27 | Warnings | M010 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 0e45d0e8-3741-7cee-e063-6394a90a2de5 | 2026-01-27 | 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 |