Home NDC 0904-5792-46 Mucus Relief Sinus
Product NDC 0904-5792
Requested package NDC 0904-5792-46
11-digit product format 009045792
Labeler code 0904
Product ID 0904-5792_ddf977dd-3e03-4725-887d-1678d9bc9e8e
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin and Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Major Pharmaceuticals
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2006-04-15
Marketing end 0000-00-00
Substance GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 400 mg/1; mg/1
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 Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ MUCUS RELIEF SINUS (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [MAJOR PHARMACEUTICALS] 3 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ MUCUS RELIEF SINUS (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [MAJOR PHARMACEUTICALS] 3 GUAIFENESIN ACTIVE MOIETY 495W7451VQ MUCUS RELIEF SINUS (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [MAJOR PHARMACEUTICALS] 3 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV MUCUS RELIEF SINUS (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [MAJOR PHARMACEUTICALS] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MUCUS RELIEF SINUS (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [MAJOR PHARMACEUTICALS] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MUCUS RELIEF SINUS (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [MAJOR PHARMACEUTICALS] 3 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D MUCUS RELIEF SINUS (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [MAJOR PHARMACEUTICALS] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MUCUS RELIEF SINUS (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [MAJOR PHARMACEUTICALS] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E MUCUS RELIEF SINUS (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [MAJOR PHARMACEUTICALS] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MUCUS RELIEF SINUS (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [MAJOR PHARMACEUTICALS] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 MUCUS RELIEF SINUS (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [MAJOR PHARMACEUTICALS] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP MUCUS RELIEF SINUS (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [MAJOR PHARMACEUTICALS] 3 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ SINUS CONGESTION PE (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [PREFERRED PHARMACEUTICALS, INC.] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ SINUS CONGESTION PE (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [PREFERRED PHARMACEUTICALS, INC.] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ SINUS CONGESTION PE (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [PREFERRED PHARMACEUTICALS, INC.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV SINUS CONGESTION PE (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [PREFERRED PHARMACEUTICALS, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SINUS CONGESTION PE (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [PREFERRED PHARMACEUTICALS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SINUS CONGESTION PE (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [PREFERRED PHARMACEUTICALS, INC.] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D SINUS CONGESTION PE (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [PREFERRED PHARMACEUTICALS, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SINUS CONGESTION PE (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [PREFERRED PHARMACEUTICALS, INC.] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E SINUS CONGESTION PE (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [PREFERRED PHARMACEUTICALS, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SINUS CONGESTION PE (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [PREFERRED PHARMACEUTICALS, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 SINUS CONGESTION PE (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [PREFERRED PHARMACEUTICALS, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SINUS CONGESTION PE (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [PREFERRED PHARMACEUTICALS, INC.] 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0904-5792-46 00904579246 1 BOTTLE, PLASTIC in 1 CARTON (0904-5792-46) > 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2006-04-15 0000-00-00 No No Current