Home NDC 69365-003 Facol Cold and Flu Night
Product NDC 69365-003
11-digit product format 693650003
Labeler code 69365
Product ID 69365-003_ee967ac8-e656-09f5-e053-2a95a90a4552
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hbr, diphenhydramine hcl
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69365-003-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 69365-003-01 f5e01cc5f278…a2eaf40c39c3…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 69365-003-01 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 69365-003-01 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 69365-003-01 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 69365-003-01 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 69365-003-01 Facol Cold and Flu Night 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 9 69365-003-01 Facol Cold and Flu Night 1 in 1 BLISTER PACK 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 NIGHT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH FACOL COLD AND FLU NIGHT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 FACOL COLD AND FLU NIGHT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ FACOL COLD AND FLU NIGHT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ FACOL COLD AND FLU NIGHT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D FACOL COLD AND FLU NIGHT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS FACOL COLD AND FLU NIGHT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M FACOL COLD AND FLU NIGHT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ FACOL COLD AND FLU NIGHT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV FACOL COLD AND FLU NIGHT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 GARDENIAN BLUE INACTIVE INGREDIENT 54A6568109 FACOL COLD AND FLU NIGHT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L FACOL COLD AND FLU NIGHT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ FACOL COLD AND FLU NIGHT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ FACOL COLD AND FLU NIGHT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FACOL COLD AND FLU NIGHT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R FACOL COLD AND FLU NIGHT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2 WATER INACTIVE INGREDIENT 059QF0KO0R FACOL COLD AND FLU NIGHT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [JW HOLDINGS] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69365-003 FACOL COLD AND FLU NIGHT (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [JW HOLDINGS] 9 Legacy NDC, 2 package rows 20240830_104a3cba-6eb2-48b3-e054-00144ff8d46c.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1664631 acetaminophen 200 MG / dextromethorphan hydrobromide 8 MG / diphenhydrAMINE 18.75 MG / guaiFENesin 35 MG / phenylephrine HCl 5 MG Oral Capsule PSN 104a3cba-6eb2-48b3-e054-00144ff8d46c 9 1664631 acetaminophen 200 MG / dextromethorphan hydrobromide 8 MG / diphenhydramine 18.75 MG / guaifenesin 35 MG / phenylephrine hydrochloride 5 MG Oral Capsule SCD 104a3cba-6eb2-48b3-e054-00144ff8d46c 9 1664631 APAP 200 MG / Dextromethorphan Hydrobromide 8 MG / Diphenhydramine 18.75 MG / Guaifenesin 35 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule SY 104a3cba-6eb2-48b3-e054-00144ff8d46c 9
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69365-003-01 69365000301 1 BLISTER PACK in 1 CARTON (69365-003-01) > 1 CAPSULE in 1 BLISTER PACK > 10 CAPSULE, LIQUID FILLED in 1 CAPSULE 1 blister pack 2015-08-01 0000-00-00 No No Current