Ultra concentrated Daytime/ Nighttime Severe Softgel
- Product NDC
- 51316-547
- 11-digit product format
- 513160547
- Labeler code
- 51316
- Product ID
- 51316-547_4de9aabc-fafa-fd37-e063-6294a90ab10c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine hydrochloride softgel
- Dosage form
- KIT
- Route
- ORAL
- Labeler
- CVS PHARMACY, INC
- 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
- Ultra concentrated Daytime/ Nighttime Severe Softgel
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 24cedaec-06a6-8fde-e063-6394a90a3d7a | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-547-24 | Ultra concentrated Daytime/ Nighttime Severe Softgel | 2 in 1 CARTON | KIT | 2 | 3 | |
| 51316-547-24 | Ultra concentrated Daytime/ Nighttime Severe Softgel | 1 in 1 BLISTER PACK | KIT | 1 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51316-547 | ULTRA CONCENTRATED DAYTIME/ NIGHTTIME SEVERE SOFTGEL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE SOFTGEL) KIT [CVS PHARMACY, INC] | 2 | Current NDC, 2 package rows | 20250429_24cedaec-06a6-8fde-e063-6394a90a3d7a.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 |
|---|---|---|---|---|---|---|
| TexaClear Pain and Chest Congestion Relief | CHOLINE SALICYLATE,GUAIFENESIN | GM Pharmaceuticals, INC | 672bc78a-2c71-4135-b64a-2b8c40ac688c | 2025-10-13 | Warnings | M012 |
| Vapor Stick | CAMPHOR/MENTHOL | Rejoice International Corp. | 33d1fbf3-d33c-58b9-e063-6294a90ae098 | 2025-10-13 | Warnings | M012 |
| Nitetime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Meijer Distribution Inc | 47f03174-6e91-4529-bbfa-ce58aa7b7d79 | 2025-10-13 | Warnings | M012 |
| Nasal Decongestant Maximum Strength | PSEUDOEPHEDRINE HCL | CHAIN DRUG MARKETING ASSOCIATION INC | db81e32b-0cad-400b-8479-a3b51de92b12 | 2025-10-10 | Warnings | M012 |
| Giltuss Childrens Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Gil Pharmaceutical Corp | 852b77ae-a5ac-3ead-e053-2a91aa0a54bd | 2025-10-09 | Warnings | M012 |
| Giltuss Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Gil Pharmaceutical Corp | 8503c956-42a5-7684-e053-2991aa0adb27 | 2025-10-09 | Warnings | M012 |
| Giltuss HBP Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Gil Pharmaceutical Corp | 852ceea2-d6a1-6de2-e053-2a91aa0ad50d | 2025-10-09 | Warnings | M012 |
| Giltuss Childrens Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Gil Pharmaceutical Corp | 852d5f01-9289-5515-e053-2a91aa0acf32 | 2025-10-09 | Warnings | M012 |
| Giltuss Diabetic Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Gil Pharmaceutical Corp | 85183b38-ce2a-0e0e-e053-2991aa0a336f | 2025-10-09 | Warnings | M012 |
| Giltuss MultiSymptom Cold and Flu | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Giltuss Pharmaceutical Corp | 8518fd91-981e-de78-e053-2a91aa0afcb2 | 2025-10-09 | Warnings | M012 |
| Giltuss Childrens MultiSymptom Cold and Flu | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Giltuss Pharmaceutical Corp | 852c8cd6-271f-0fa8-e053-2991aa0ab179 | 2025-10-09 | Warnings | M012 |
| Giltuss Allergy Plus Cough and Congestion | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Gil Pharmaceutical Corp | 85065cf3-386d-22d5-e053-2a91aa0a72da | 2025-10-09 | Warnings | M012 |
| Giltuss Honey Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Gil Pharmaceutical Corp | a8b2c847-25e9-8714-e053-2995a90a73ce | 2025-10-09 | Warnings | M012 |
| Giltuss Childrens Allergy Plus Cough and Congestion | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Gil Pharmaceutical Corp | 852c5a57-7ee4-3c5c-e053-2a91aa0a1433 | 2025-10-09 | Warnings | M012 |
| Childrens Giltuss Honey DM Cough | DEXTROMETHORPHAN HBR | Gil Pharmaceutical Corp | a8c5027f-9701-fb07-e053-2a95a90a6029 | 2025-10-09 | Warnings | M012 |
| Childrens Giltuss Honey Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Gil Pharmaceutical Corp | a8c052d8-fb9f-09f2-e053-2a95a90a37af | 2025-10-09 | Warnings | M012 |
| Giltuss EX Expectorant | GUAIFENESIN | Gil Pharmaceutical Corp | a8c53c14-ba82-2c68-e053-2a95a90a9894 | 2025-10-09 | Warnings | M012 |
| Giltuss Severe Sinus | OXYMETAZOLINE HCL | Gil Pharmaceutical Corp | ab7fae3b-1f7d-5d0f-e053-2a95a90a148e | 2025-10-09 | Warnings | M012 |
| Giltuss Honey DM Cough | DEXTROMETHORPHAN HBR | Gil Pharmaceutical Corp | a8c08532-1169-6603-e053-2a95a90a3484 | 2025-10-09 | Warnings | M012 |
| Childrens Giltuss EX Expectorant | GUAIFENESIN | Gil Pharmaceutical Corp | a8c59e6d-c11c-2664-e053-2a95a90a8333 | 2025-10-09 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2634363 | {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 / phenylephrine hydrochloride 5 MG Oral Capsule) } Pack | GPCK | 24cedaec-06a6-8fde-e063-6394a90a3d7a | 3 |
| 2634363 | 1 daytime (acetaminophen 325 MG / dextromethorphan Hbr 10 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 | 24cedaec-06a6-8fde-e063-6394a90a3d7a | 3 |
| 1297288 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 24cedaec-06a6-8fde-e063-6394a90a3d7a | 3 |
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 24cedaec-06a6-8fde-e063-6394a90a3d7a | 3 |
| 1297288 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 24cedaec-06a6-8fde-e063-6394a90a3d7a | 3 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 24cedaec-06a6-8fde-e063-6394a90a3d7a | 3 |
| 2634363 | 1 daytime (acetaminophen 325 MG / dextromethorphan Hbr 10 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 | 24cedaec-06a6-8fde-e063-6394a90a3d7a | 3 |
| 1297288 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 24cedaec-06a6-8fde-e063-6394a90a3d7a | 3 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 24cedaec-06a6-8fde-e063-6394a90a3d7a | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51316-547-24 | 51316054724 | 2 BLISTER PACK in 1 CARTON (51316-547-24) / 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 |