Home NDC 58809-729-04 Nasopen
Product NDC 58809-729
Requested package NDC 58809-729-04
11-digit product format 588090729
Labeler code 58809
Product ID 58809-729_f1ed4a45-46d9-fca9-e053-2a95a90a7023
Type HUMAN OTC DRUG
Nonproprietary name Phenylephrine Hydrochloride, Thonzylamine Hydrochloride
Dosage form LIQUID
Route ORAL
Labeler GM Pharmaceuticals, INC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-10-03
Marketing end 0000-00-00
Substance PHENYLEPHRINE HYDROCHLORIDE; THONZYLAMINE HYDROCHLORIDE
Active strength 10 mg/15mL; mg/15mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2024-12-31
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 · 9 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…
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 Phenylephrine Hydrochloride ACTIVE INGREDIENT 04JA59TNSJ NASOPEN PE (PHENYLEPHRINE HYDROCHLORIDE, THONZYLAMINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS, INC] 2 Thonzylamine Hydrochloride ACTIVE INGREDIENT 6K9YKD48Y4 NASOPEN PE (PHENYLEPHRINE HYDROCHLORIDE, THONZYLAMINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS, INC] 2 Phenylephrine ACTIVE MOIETY 1WS297W6MV NASOPEN PE (PHENYLEPHRINE HYDROCHLORIDE, THONZYLAMINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS, INC] 2 Thonzylamine ACTIVE MOIETY R79646H5Z8 NASOPEN PE (PHENYLEPHRINE HYDROCHLORIDE, THONZYLAMINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS, INC] 2 Glycerin INACTIVE INGREDIENT PDC6A3C0OX NASOPEN PE (PHENYLEPHRINE HYDROCHLORIDE, THONZYLAMINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS, INC] 2 Maltitol INACTIVE INGREDIENT D65DG142WK NASOPEN PE (PHENYLEPHRINE HYDROCHLORIDE, THONZYLAMINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS, INC] 2 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 NASOPEN PE (PHENYLEPHRINE HYDROCHLORIDE, THONZYLAMINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS, INC] 2 Saccharin Sodium INACTIVE INGREDIENT SB8ZUX40TY NASOPEN PE (PHENYLEPHRINE HYDROCHLORIDE, THONZYLAMINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS, INC] 2 Sorbitol INACTIVE INGREDIENT 506T60A25R NASOPEN PE (PHENYLEPHRINE HYDROCHLORIDE, THONZYLAMINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS, INC] 2 Sucralose INACTIVE INGREDIENT 96K6UQ3ZD4 NASOPEN PE (PHENYLEPHRINE HYDROCHLORIDE, THONZYLAMINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS, INC] 2 Water INACTIVE INGREDIENT 059QF0KO0R NASOPEN PE (PHENYLEPHRINE HYDROCHLORIDE, THONZYLAMINE HYDROCHLORIDE) LIQUID [GM PHARMACEUTICALS, INC] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58809-729-04 58809072904 118 mL in 1 BOTTLE (58809-729-04) 118 ml 2012-10-03 0000-00-00 No No Current