hydro gel

Generic: glycerin 20%

Labeler: trifecta pharmaceuticals usa llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hydro gel
Generic Name glycerin 20%
Labeler trifecta pharmaceuticals usa llc
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

glycerin 20 g/100g

Manufacturer
Trifecta Pharmaceuticals USA LLC

Identifiers & Regulatory

Product NDC 69396-127
Product ID 69396-127_0f4e25fa-bccd-b725-e063-6294a90ac340
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2023-08-14

Pharmacologic Class

Established (EPC)
non-standardized chemical allergen [epc]
Chemical Structure
allergens [cs] glycerol [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe] increased igg production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69396127
Hyphenated Format 69396-127

Supplemental Identifiers

UPC
0850026393835
UNII
PDC6A3C0OX
NUI
N0000185370 N0000175629 N0000184306 N0000185001 M0000728 M0009417

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hydro gel (source: ndc)
Generic Name glycerin 20% (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (69396-127-03) / 84.7 g in 1 TUBE
source: ndc

Packages (1)

69396-127-03 1 TUBE in 1 BOX (69396-127-03) / 84.7 g in 1 TUBE

Ingredients (1)

glycerin (20 g/100g)

Linked Drug Pages (1)

Hydro Gel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0f4e25fa-bccd-b725-e063-6294a90ac340", "openfda": {"nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "upc": ["0850026393835"], "unii": ["PDC6A3C0OX"], "spl_set_id": ["02e8e5d0-7844-39fe-e063-6394a90a57e1"], "pharm_class_cs": ["Allergens [CS]", "Glycerol [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]"], "pharm_class_epc": ["Non-Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["Trifecta Pharmaceuticals USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (69396-127-03)  / 84.7 g in 1 TUBE", "package_ndc": "69396-127-03", "marketing_start_date": "20230823"}], "brand_name": "Hydro Gel", "product_id": "69396-127_0f4e25fa-bccd-b725-e063-6294a90ac340", "dosage_form": "GEL", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Glycerol [CS]", "Increased Histamine Release [PE]", "Increased IgG Production [PE]", "Non-Standardized Chemical Allergen [EPC]"], "product_ndc": "69396-127", "generic_name": "Glycerin 20%", "labeler_name": "Trifecta Pharmaceuticals USA LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Hydro Gel", "active_ingredients": [{"name": "GLYCERIN", "strength": "20 g/100g"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230814", "listing_expiration_date": "20261231"}