Home NDC 54799-503-15 GONIOSOFT
Product NDC 54799-503
Requested package NDC 54799-503-15
11-digit product format 547990503
Labeler code 54799
Product ID 54799-503_773acc2d-60e9-40c5-9d5f-2e4b121e9c80
Type HUMAN OTC DRUG
Nonproprietary name Hypromellose 2.5%
Dosage form LIQUID
Route OPHTHALMIC
Labeler OCuSOFT, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 1989-10-02
Marketing end 2022-01-31
Substance HYPROMELLOSES
Active strength 25 mg/mL
NDC exclude flag No
Listing certified through 0000-00-00
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 Hypromelloses ACTIVE INGREDIENT 3NXW29V3WO GONIOSOFT (HYPROMELLOSE 2.5%) LIQUID [OCUSOFT, INC.] 1 Hypromelloses ACTIVE MOIETY 3NXW29V3WO GONIOSOFT (HYPROMELLOSE 2.5%) LIQUID [OCUSOFT, INC.] 1 Benzalkonium Chloride INACTIVE INGREDIENT F5UM2KM3W7 GONIOSOFT (HYPROMELLOSE 2.5%) LIQUID [OCUSOFT, INC.] 1 Boric Acid INACTIVE INGREDIENT R57ZHV85D4 GONIOSOFT (HYPROMELLOSE 2.5%) LIQUID [OCUSOFT, INC.] 1 Edetate Disodium INACTIVE INGREDIENT 7FLD91C86K GONIOSOFT (HYPROMELLOSE 2.5%) LIQUID [OCUSOFT, INC.] 1 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB GONIOSOFT (HYPROMELLOSE 2.5%) LIQUID [OCUSOFT, INC.] 1 Sodium Borate INACTIVE INGREDIENT 91MBZ8H3QO GONIOSOFT (HYPROMELLOSE 2.5%) LIQUID [OCUSOFT, INC.] 1 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I GONIOSOFT (HYPROMELLOSE 2.5%) LIQUID [OCUSOFT, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R GONIOSOFT (HYPROMELLOSE 2.5%) LIQUID [OCUSOFT, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54799-503-15 54799050315 15 mL in 1 BOTTLE, PLASTIC (54799-503-15) 15 ml 1989-10-02 2022-01-31 No No Current