Facol Cold and Flu Day and Night
- Product NDC
- 69365-004
- 11-digit product format
- 693650004
- Labeler code
- 69365
- Product ID
- 69365-004_ee967298-7aa4-4ec7-e053-2a95a90a4ee5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminphen, guaifenesin, phenylephrine hcl, dextromethorphan hbr, diphenhydramine hcl, lac color, gardenia blue
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- JW HOLDINGS
- Application
- part343
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2015-08-01
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DIPHENHYDRAMINE HYDROCHLORIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 200 mg/1; mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Increased Respiratory Secretions [PE], 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69365-004-01 | 2025-07-29 | C162847 | 48780-1 | 1030e364-f922-111a-e063-dadaa90a10e2 | FACOL COLD AND FLU DAY AND NIGHT |
| 69365-004-01 | 2024-08-29 | C162847 | 48780-1 | 1030e364-f922-111a-e063-dadaa90a10e2 | FACOL COLD AND FLU DAY AND NIGHT |
| 69365-004-01 | 2024-01-30 | C162847 | 48780-1 | 1030e364-f922-111a-e063-dadaa90a10e2 | FACOL COLD AND FLU DAY AND NIGHT |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69365-004-01 | Facol Cold and Flu Day and Night | 1 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 1 | 7 | |
| 69365-004-01 | Facol Cold and Flu Day and Night | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69365-004 | FACOL COLD AND FLU DAY AND NIGHT (ACETAMINPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, LAC COLOR, GARDENIA BLUE) CAPSULE, LIQUID FILLED [JW HOLDINGS] | 7 | Legacy NDC, 2 package rows | 20240830_179486ed-7e06-218e-e054-00144ff8d46c.zip |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69365-004-01 | 69365000401 | 1 BLISTER PACK in 1 CARTON (69365-004-01) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 blister pack | 2015-08-01 | 0000-00-00 | No | No | Current |