Daytime Nighttime Cold and Flu
- Product NDC
- 49483-695
- 11-digit product format
- 494830695
- Labeler code
- 49483
- Product ID
- 49483-695_2dc46c8a-7915-d95d-e063-6394a90aafa9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI, Doxylamine Succinate 325, 10/15, 5, 6.25 mg softgels
- Dosage form
- KIT
- Route
- ORAL
- Labeler
- TIME CAP LABORATORIES INC.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-06-07
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Daytime Nighttime Cold and Flu
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 1086997, 1094549, 2634564 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49483-695-48 | 2025-02-10 | C162847 | 48780-1 | 2cef2736-9824-d83d-e063-dadaa90ab31f | 695T_Timely_49483-695_Daytime and Nighttime cold & flu softgels |
| 49483-695-48 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9824-d83d-e063-dadaa90ab31f | 695T_Timely_49483-695_Daytime and Nighttime cold & flu softgels |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49483-695-48 | Daytime Nighttime Cold and Flu | 1 in 1 BLISTER PACK | KIT | 1 | 2 | |
| 49483-695-48 | Daytime Nighttime Cold and Flu | 4 in 1 CARTON | KIT | 4 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49483-695 | DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI, DOXYLAMINE SUCCINATE 325, 10/15, 5, 6.25 MG SOFTGELS) KIT [TIME CAP LABORATORIES INC.] | 2 | Current NDC, 2 package rows | 20250212_fd81dd4b-9617-f4c1-e053-6394a90a5e72.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2634564 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } Pack | GPCK | fd81dd4b-9617-f4c1-e053-6394a90a5e72 | 2 |
| 2634564 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | PSN | fd81dd4b-9617-f4c1-e053-6394a90a5e72 | 2 |
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | fd81dd4b-9617-f4c1-e053-6394a90a5e72 | 2 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | fd81dd4b-9617-f4c1-e053-6394a90a5e72 | 2 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | fd81dd4b-9617-f4c1-e053-6394a90a5e72 | 2 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | fd81dd4b-9617-f4c1-e053-6394a90a5e72 | 2 |
| 2634564 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | SY | fd81dd4b-9617-f4c1-e053-6394a90a5e72 | 2 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | fd81dd4b-9617-f4c1-e053-6394a90a5e72 | 2 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | fd81dd4b-9617-f4c1-e053-6394a90a5e72 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 49483-695-48 | 49483069548 | 4 BLISTER PACK in 1 CARTON (49483-695-48) / 1 KIT in 1 BLISTER PACK * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 4 blister pack | 2023-06-07 | No | No | Current |