Home NDC 64543-044-01 Rescon GG
Product NDC 64543-044
Requested package NDC 64543-044-01
11-digit product format 645430044
Labeler code 64543
Product ID 64543-044_edfe66d3-63a8-100c-e053-2a95a90aba47
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin and Phenylephrine Hydrochloride
Dosage form LIQUID
Route ORAL
Labeler Capellon Pharmaceuticals, LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 1999-01-01
Marketing end 0000-00-00
Substance GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 100 mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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, 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…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R RESCON GG (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CAPELLON PHARMACEUTICALS, LLC] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64543-044-01 64543004401 25 mL in 1 BOTTLE (64543-044-01) 25 ml 1999-01-01 0000-00-00 Yes No Current