| Product ID | 69365-004_7bc71348-5272-64a9-e053-2a91aa0ae9db |
| NDC | 69365-004 |
| Product Type | Human Otc Drug |
| Proprietary Name | Facol Cold and Flu Day and Night |
| Generic Name | Acetaminphen, Guaifenesin, Phenylephrine Hcl, Dextromethorphan Hbr, Diphenhydramine Hcl, Lac Color, Gardenia Blue |
| Dosage Form | Capsule, Liquid Filled |
| Route of Administration | ORAL |
| Marketing Start Date | 2015-08-01 |
| Marketing Category | OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL |
| Application Number | part343 |
| Labeler Name | JW HOLDINGS |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN; ACETAMINOPHEN |
| Active Ingredient Strength | 19 mg/1; mg/1; mg/1; mg/1; mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |