Home NDC 69365-001-01 Facol Cold and Flu Day
Product NDC 69365-001
Requested package NDC 69365-001-01
11-digit product format 693650001
Labeler code 69365
Product ID 69365-001_ee967298-7aa5-4ec7-e053-2a95a90a4ee5
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hydrobromide
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; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 200 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69365-001-01 Facol Cold and Flu Day 1 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 1 9 69365-001-01 Facol Cold and Flu Day 1 in 1 KIT CAPSULE, LIQUID FILLED 1 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D FACOL COLD AND FLU DAY (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH FACOL COLD AND FLU DAY (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ FACOL COLD AND FLU DAY (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ FACOL COLD AND FLU DAY (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D FACOL COLD AND FLU DAY (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS FACOL COLD AND FLU DAY (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ FACOL COLD AND FLU DAY (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV FACOL COLD AND FLU DAY (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 FACOL COLD AND FLU DAY (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 COCHINEAL INACTIVE INGREDIENT TZ8Z31B35M FACOL COLD AND FLU DAY (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L FACOL COLD AND FLU DAY (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ FACOL COLD AND FLU DAY (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ FACOL COLD AND FLU DAY (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FACOL COLD AND FLU DAY (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R FACOL COLD AND FLU DAY (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 WATER INACTIVE INGREDIENT 059QF0KO0R FACOL COLD AND FLU DAY (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69365-001 FACOL COLD AND FLU DAY (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [JW HOLDINGS] 9 Legacy NDC, 2 package rows 20240830_0e273007-36ca-320f-e054-00144ff8d46c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69365-001-01 69365000101 1 BLISTER PACK in 1 KIT (69365-001-01) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 1 blister pack 2015-08-01 0000-00-00 No No Current