Daytime cold and flu
- Product NDC
- 49483-693
- 11-digit product format
- 494830693
- Labeler code
- 49483
- Product ID
- 49483-693_2dc3a685-34e1-0823-e063-6294a90ad27d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI 325, 10, 5 mg softgels
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- TIME CAP LABORATORIES, INC.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-07-06
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 5 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Daytime cold and flu
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ |
| Rxcui | 1086997 |
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 |
|---|---|---|---|---|---|
| 49483-693-48 | 2025-02-10 | C162847 | 48780-1 | 2cef2736-87fe-d83d-e063-dadaa90ab31f | 693T_49483-693_Timely_Acetaminophen/ Dextromethorphan HBr/ Phenylephrine HCI 325/10/5mg softgels |
| 49483-693-48 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-87fe-d83d-e063-dadaa90ab31f | 693T_49483-693_Timely_Acetaminophen/ Dextromethorphan HBr/ Phenylephrine HCI 325/10/5mg softgels |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49483-693-48 | Daytime cold and flu | 4 in 1 CARTON | CAPSULE, LIQUID FILLED | 4 | 2 | |
| 49483-693-48 | Daytime cold and flu | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49483-693 | DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI 325, 10, 5 MG SOFTGELS) CAPSULE, LIQUID FILLED [TIME CAP LABORATORIES, INC.] | 2 | Current NDC, 2 package rows | 20250212_fd24653e-c4fa-3c09-e053-6394a90aaa9e.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 | fd24653e-c4fa-3c09-e053-6394a90aaa9e | 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 | fd24653e-c4fa-3c09-e053-6394a90aaa9e | 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 | fd24653e-c4fa-3c09-e053-6394a90aaa9e | 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 |
|---|---|---|---|---|---|---|---|
| 49483-693-48 | 49483069348 | 4 BLISTER PACK in 1 CARTON (49483-693-48) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 4 blister pack | 2023-07-06 | No | No | Current |