CVS PHARMACY
- Product NDC
- 51316-635
- 11-digit product format
- 513160635
- Labeler code
- 51316
- Product ID
- 51316-635_18c65cf1-b3d8-4764-8b5d-d77ea642df5d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Brompheniramine maleate,Dextromethorphan HBr,Diphenhydramine HCl
- Dosage form
- KIT
- Labeler
- CVS PHARMACY, INC.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-03-03
- 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 PHARMACY
- Brand name suffix
- COLD and COUGH And NIGHTTIME VALUE PACK
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4d94968b-ada3-4344-8563-cba7fc491d74 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-632-04 | CVS PHARMACYCOLD and COUGH And NIGHTTIME VALUE PACK | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 mL | 2 mg in 10mL | 2 |
| 51316-635-08 | CVS PHARMACYCOLD and COUGH And NIGHTTIME VALUE PACK | 1 in 1 KIT | KIT | 1 | 2 | |
| 51316-646-04 | CVS PHARMACYCOLD and COUGH And NIGHTTIME VALUE PACK | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 mL | 12.5 mg in 10mL | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51316-635 | CVS PHARMACY COLD AND COUGH AND NIGHTTIME VALUE PACK (BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL) KIT [CVS PHARMACY, INC.] | 1 | Current NDC, 3 package rows | 20250322_4d94968b-ada3-4344-8563-cba7fc491d74.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 |
|---|---|---|---|---|---|---|
| Benadryl Allergy EXTRA STRENGTH | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | dd0a8069-18d8-5696-e053-2995a90a2f22 | 2024-09-06 | Warnings | M012 |
| Guaifenesin and Codeine Phosphate | GUAIFENESIN AND CODEINE PHOSPHATE | PAI Holdings, LLC | 88d0994c-4270-4408-8837-bd97510b2118 | 2024-09-06 | Warnings | M012 |
| QCH Maximum Strength Mucus Relief 617 | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Chain Drug Marketing Association Inc. | a1c5c15e-0f3a-47d3-b9ed-1e0018417514 | 2024-09-06 | Warnings | M012 |
| Theraflu Severe Cold Relief Nighttime Soft Chews | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | 6ba64bbe-7599-406a-9187-737c0f8c1c2a | 2024-09-05 | Warnings | M012 |
| Cough Relief Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Best Choice (Valu Merchandisers Company) | 344282fc-3bd1-4f49-9bd1-08c5a58d1f73 | 2024-09-05 | Warnings | M012 |
| Equate Nasal | PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | 95ef1819-edc3-4dda-8514-85b61538cc72 | 2024-09-04 | Warnings | M012 |
| Up and up nasal | OXYMETAZOLINE HYDROCHLORIDE | Target Corporation | 0c246c11-eadd-4ac6-bd58-5fdb151e06d6 | 2024-09-04 | Warnings | M012 |
| Exchange Select Nasal | OXYMETAZOLINE HYDROCHLORIDE | Army & Air Force Exchange Service | aafa9163-f08e-48c9-9ca1-7b72f67d007d | 2024-08-31 | Warnings | M012 |
| nasal 12 hour | OXYMETAZOLINE HYDROCHLORIDE | Meijer Distribution Inc | e9ee03db-a070-4c2b-ac61-7fd22bab2795 | 2024-08-31 | Warnings | M012 |
| dg health nasal | OXYMETAZOLINE HYDROCHLORIDE | Dolgencorp, LLC | 42b58928-e8e5-49e4-b49e-498d77d64fcd | 2024-08-28 | Warnings | M012 |
| nasal mist | OXYMETAZOLINE HCL | CVS Pharmacy | b71c557a-eb93-40d1-87c4-847f5468fc1e | 2024-08-28 | Warnings | M012 |
| nasal | OXYMETAZOLINE HCL | Kroger Company | 0a24d98a-5950-49de-8b77-ea880b08d2c5 | 2024-08-28 | Warnings | M012 |
| basic care no drip nasal | OXYMETAZOLINE HYDROCHLORIDE | Amazon.com Services LLC | 96e018e2-e0b5-4802-a4a1-73a73d574082 | 2024-08-28 | Warnings | M012 |
| Topcare Nasal | OXYMETAZOLINE HCL | Topco Associates LLC | b5434599-5485-4949-9d76-b1ef3ad17c1a | 2024-08-28 | Warnings | M012 |
| basic care no drip nasal | OXYMETAZOLINE HYDROCHLORIDE | Amazon.com Services LLC | b15eb271-7842-495b-aa0f-9b20def86dc1 | 2024-08-28 | Warnings | M012 |
| Topcare Nasal | OXYMETAZOLINE HYDROCHLORIDE | Topco Associates LLC | f1dd78e0-f700-4469-85d6-18cc299e8746 | 2024-08-28 | Warnings | M012 |
| equaline nasal | OXYMETAZOLINE HCL | United Natural Foods, Inc. dba UNFI | 69308693-a094-42a9-a041-e73647a25cc1 | 2024-08-27 | Warnings | M012 |
| signature care nasal decongestant | OXYMETAZOLINE HYDROCHLORIDE | Safeway | f9ac80d1-3753-412b-a407-18a6b50e5d1c | 2024-08-27 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 20ac6010-84f4-eeff-e063-6294a90a50a7 | 2024-08-27 | Warnings | M012 |
| Exchange Select Nasal | OXYMETAZOLINE HCL | Army & Air Force Exchange Service | 40d2090d-c332-4dcb-9f43-5ee467e7b3d1 | 2024-08-27 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2683422 | {1 (brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution) / 1 (diphenhydramine hydrochloride 1.25 MG/ML Oral Solution) } Pack | GPCK | 4d94968b-ada3-4344-8563-cba7fc491d74 | 2 |
| 2683422 | 1 daytime (brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG in 10 mL Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 12.5 MG in 10 mL Oral Solution) Pack | PSN | 4d94968b-ada3-4344-8563-cba7fc491d74 | 2 |
| 2683421 | brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG in 10 mL Oral Solution | PSN | 4d94968b-ada3-4344-8563-cba7fc491d74 | 2 |
| 1049884 | diphenhydrAMINE HCl 50 MG in 40 mL Oral Solution | PSN | 4d94968b-ada3-4344-8563-cba7fc491d74 | 2 |
| 2683421 | brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution | SCD | 4d94968b-ada3-4344-8563-cba7fc491d74 | 2 |
| 1049884 | diphenhydramine hydrochloride 1.25 MG/ML Oral Solution | SCD | 4d94968b-ada3-4344-8563-cba7fc491d74 | 2 |
| 2683422 | 1 daytime (brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG per 10 mL Oral Solution) / 1 nighttime (diphenhydramine HCl 12.5 MG per 10 mL Oral Solution) Pack | SY | 4d94968b-ada3-4344-8563-cba7fc491d74 | 2 |
| 2683421 | brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG per 10 ML Oral Solution | SY | 4d94968b-ada3-4344-8563-cba7fc491d74 | 2 |
| 1049884 | diphenhydramine hydrochloride 50 MG per 40 ML Oral Solution | SY | 4d94968b-ada3-4344-8563-cba7fc491d74 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51316-632-04 | 51316063204 | 118 mL in 1 BOTTLE, PLASTIC | 118 ml | Historical | |||
| 51316-635-08 | 51316063508 | 1 KIT in 1 KIT (51316-635-08) * 118 mL in 1 BOTTLE, PLASTIC (51316-632-04) * 118 mL in 1 BOTTLE, PLASTIC (51316-646-04) | 1 kit | 2025-03-03 | No | No | Current |
| 51316-646-04 | 51316064604 | 118 mL in 1 BOTTLE, PLASTIC | 118 ml | Historical |