Daytime Nighttime Severe Cold and Flu
- Product NDC
- 51316-527
- 11-digit product format
- 513160527
- Labeler code
- 51316
- Product ID
- 51316-527_4d1d8a10-476d-1352-e063-6294a90a1279
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Doxylamine Succinate, Phenylephrine HCl
- Dosage form
- KIT
- Route
- ORAL
- Labeler
- CVS HEALTH CORP
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-02-01
- 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
- Daytime Nighttime Severe Cold and Flu
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 23e2d2dc-12d4-294d-e063-6394a90a9523 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-527-24 | Daytime Nighttime Severe Cold and Flu | 2 in 1 CARTON | KIT | 2 | 3 | |
| 51316-527-24 | Daytime Nighttime Severe Cold and Flu | 1 in 1 BLISTER PACK | KIT | 1 | 3 | |
| 51316-527-48 | Daytime Nighttime Severe Cold and Flu | 4 in 1 CARTON | KIT | 4 | 3 | |
| 51316-527-48 | Daytime Nighttime Severe Cold and Flu | 1 in 1 BLISTER PACK | KIT | 1 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51316-527 | DAYTIME NIGHTTIME SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS HEALTH CORP] | 2 | Current NDC, 4 package rows | 20250429_23e2d2dc-12d4-294d-e063-6394a90a9523.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 |
|---|---|---|---|---|---|---|
| daytime nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreen Company | 4b49137c-8fc9-43b7-b1a1-82e318237eb6 | 2024-11-12 | Warnings | M012 |
| CVS Original Nasal Mist | OXYMETAZOLINE HCL | CVS PHARMACY, INC | e9c551a0-cd78-4272-b42f-36c096d26736 | 2024-11-12 | Warnings | M012 |
| up and up cough plus chest congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Target Corporation | ed5dfeb1-8f7a-46ff-ae27-3fa5de5b397c | 2024-11-12 | Warnings | M012 |
| DG Health Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp Inc | b33d104b-0b4d-40c6-8345-c2c740327331 | 2024-11-11 | Warnings | M012 |
| Zephrex D | PSEUDOEPHEDRINE HYDROCHLORIDE | L. Perrigo Company | 5468a7e2-361b-494f-9ca3-1b62f3819f65 | 2024-11-11 | Warnings | M012 |
| careone tussin dm | DEXTROMETHORPHAN HBR, GUAIFENESIN | American Sales Company | 6c90fccf-0e6f-43df-9468-d8ece8ded009 | 2024-11-11 | Warnings | M012 |
| good sense night time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | 89dc1423-d097-47a8-9025-eab5381cca26 | 2024-11-11 | Warnings | M012 |
| basic care nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 10f9627b-edda-422a-b01f-7066f9c98335 | 2024-11-11 | Warnings | M012 |
| nighttime severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 17c3fe42-3c40-4405-80b7-b3f9e4aa8376 | 2024-11-11 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | H E B | 1dd36aa7-f085-4350-8cf2-f9fa29b583e4 | 2024-11-11 | Warnings | M012 |
| topcare nite time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | a7f9f1d0-7498-461c-b4e8-4c92cf3feae8 | 2024-11-11 | Warnings | M012 |
| nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Walgreen Company | bd079f5d-0a38-40e6-9661-e8236c88a24d | 2024-11-11 | Warnings | M012 |
| GUAIFENESIN DM | GUAIFENESIN AND DEXTROMETHORPHAN | PAI Holdings, LLC dba PAI Pharma | ff970fff-d1a3-4322-83b4-34e361431a1c | 2024-11-11 | Warnings | M012 |
| topcare tussin dm max | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | e1118592-30ac-4505-9f38-c6d395c4cf5b | 2024-11-11 | Warnings | M012 |
| basic care nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 624b8029-9fdb-4908-a13b-f9dd75030120 | 2024-11-11 | Warnings | M012 |
| Biofreeze Colorless | MENTHOL | A-S Medication Solutions | cc1cba14-da40-4d7d-b522-b5c648798e96 | 2024-11-11 | Warnings | M012 |
| foster and thrive nighttime severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Strategic Sourcing Services LLC | 298b7754-d0d8-496d-9949-4c346cb11e34 | 2024-11-11 | Warnings | M012 |
| leader tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Cardinal Health 110, LLC. dba Leader | b418c10c-528b-4395-944e-af959b639ec2 | 2024-11-10 | Warnings | M012 |
| equaline adult tussin | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | United Natural Foods, Inc. dba UNFI | f7c753f8-4b12-4797-a599-736d597bc1bc | 2024-11-10 | Warnings | M012 |
| foster and thrive adult tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Strategic Sourcing Services LLC | f8933226-fbc9-44e3-a90f-4e6c1dbdb7b7 | 2024-11-10 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2634364 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } Pack | GPCK | 23e2d2dc-12d4-294d-e063-6394a90a9523 | 3 |
| 2634364 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) Pack | PSN | 23e2d2dc-12d4-294d-e063-6394a90a9523 | 3 |
| 1297288 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 23e2d2dc-12d4-294d-e063-6394a90a9523 | 3 |
| 1656815 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 23e2d2dc-12d4-294d-e063-6394a90a9523 | 3 |
| 1297288 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 23e2d2dc-12d4-294d-e063-6394a90a9523 | 3 |
| 1656815 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 23e2d2dc-12d4-294d-e063-6394a90a9523 | 3 |
| 2634364 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) Pack | SY | 23e2d2dc-12d4-294d-e063-6394a90a9523 | 3 |
| 1297288 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 23e2d2dc-12d4-294d-e063-6394a90a9523 | 3 |
| 1656815 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 23e2d2dc-12d4-294d-e063-6394a90a9523 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51316-527-24 | 51316052724 | 2 BLISTER PACK in 1 CARTON (51316-527-24) / 1 KIT in 1 BLISTER PACK * 8 CAPSULE in 1 BLISTER PACK * 4 CAPSULE in 1 BLISTER PACK | 2 blister pack | 2025-02-01 | No | No | Current |
| 51316-527-48 | 51316052748 | 4 BLISTER PACK in 1 CARTON (51316-527-48) / 1 KIT in 1 BLISTER PACK * 8 CAPSULE in 1 BLISTER PACK * 4 CAPSULE in 1 BLISTER PACK | 4 blister pack | 2025-02-01 | No | No | Current |