Home NDC 69396-127 Hydro Gel
Product NDC 69396-127
11-digit product format 693960127
Labeler code 69396
Product ID 69396-127_0f4e25fa-bccd-b725-e063-6294a90ac340
Type HUMAN OTC DRUG
Nonproprietary name Glycerin 20%
Dosage form GEL
Route TOPICAL
Labeler Trifecta Pharmaceuticals USA LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-08-14
Substance GLYCERIN
Active strength 20 g/100g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Hydro Gel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GLYCERIN 20 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PDC6A3C0OX Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69396-127-03 Hydro Gel 1 in 1 BOX GEL 1 2 69396-127-03 Hydro Gel 84.7 g in 1 TUBE GEL 84.7 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69396-127 HYDRO GEL (GLYCERIN 20%) GEL [TRIFECTA PHARMACEUTICALS USA LLC] 2 Current NDC, 2 package rows 20240120_02e8e5d0-7844-39fe-e063-6394a90a57e1.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 53 of 68 · 1,357 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69396-127-03 69396012703 1 TUBE in 1 BOX (69396-127-03) / 84.7 g in 1 TUBE 1 tube 2023-08-23 No No Current