Home NDC 58809-350 VANACOF-8
Product NDC 58809-350
11-digit product format 588090350
Labeler code 58809
Product ID 58809-350_828f30bb-6409-4610-b6c6-9c60eb0426c4
Type HUMAN OTC DRUG
Nonproprietary name CHLOPHEDIANOL HYDROCHLORIDE and PYRILAMINE MALEATE
Dosage form LIQUID
Route ORAL
Labeler GM PHARMACEUTICALS,INC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-06-01
Marketing end 0000-00-00
Substance CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE
Active strength 25 mg/15mL; mg/15mL
NDC exclude flag E
Listing certified through 2017-12-31
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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 58809-350-04 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 58809-350-04 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 58809-350-04 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 58809-350-04 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 58809-350-04 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 58809-350-04 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 58809-350-04 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 58809-350-04 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58809-350-04 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 58809-350-04 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 58809-350-04 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 58809-350-04 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 58809-350-04 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 58809-350-04 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product I Inactivated by FDA 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 58809-350-04 I Inactivated by FDA 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CHLOPHEDIANOL HYDROCHLORIDE ACTIVE INGREDIENT 69QQ58998Y VANACOF-8 (CHLOPHEDIANOL HYDROCHLORIDE AND PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS,INC] 1 PYRILAMINE MALEATE ACTIVE INGREDIENT R35D29L3ZA VANACOF-8 (CHLOPHEDIANOL HYDROCHLORIDE AND PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS,INC] 1 CHLOPHEDIANOL ACTIVE MOIETY 42C50P12AP VANACOF-8 (CHLOPHEDIANOL HYDROCHLORIDE AND PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS,INC] 1 PYRILAMINE ACTIVE MOIETY HPE317O9TL VANACOF-8 (CHLOPHEDIANOL HYDROCHLORIDE AND PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS,INC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX VANACOF-8 (CHLOPHEDIANOL HYDROCHLORIDE AND PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS,INC] 1 MALTITOL INACTIVE INGREDIENT D65DG142WK VANACOF-8 (CHLOPHEDIANOL HYDROCHLORIDE AND PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS,INC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 VANACOF-8 (CHLOPHEDIANOL HYDROCHLORIDE AND PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS,INC] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY VANACOF-8 (CHLOPHEDIANOL HYDROCHLORIDE AND PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS,INC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R VANACOF-8 (CHLOPHEDIANOL HYDROCHLORIDE AND PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS,INC] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 VANACOF-8 (CHLOPHEDIANOL HYDROCHLORIDE AND PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS,INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R VANACOF-8 (CHLOPHEDIANOL HYDROCHLORIDE AND PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS,INC] 1