FDA.reportPublic FDA data

A+D Antimicrobial Hydrogel

Primary DI
00365197409105
Brand
A+D Antimicrobial Hydrogel
Company
Sonoma Pharmaceuticals, Inc.
Model
86034
Catalog number
40910
Published
2026-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171935000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171935000Alevicyn SG Antimicrobial GelSonoma Pharmaceuticals, Inc.2017-12-01FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10365197409102PackageGS18In Commercial Distribution
20365197409109PackageGS13In Commercial Distribution
00365197409105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1036519740910210365197409102
2036519740910920365197409109
00365197409105003651974091053651974091050365197409105

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, non-antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight0

Regulatory Flags#

DUNS number
081642964
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10365197851000Bactine Antimicrobial Hydrogel Spray 86045851002026-01-16
20365197409208A+D Hydrogel Spray Advanced Dermatitis Care86046409202025-11-24
20365197409406A+D Gentle Face Relief86049409402025-11-24
20365197504101Solarcaine Advanced Burn Relief Hydrogel50410504102025-09-05
20365197504002Solarcaine Advanced Burn Relief Hydrogel86035860352025-07-22
20365197851106Bactine Antimicrobial Wound Care Hydrogel86043860432025-07-22
10850015491839PhaseOne Antimicrobial Solution15473154732025-07-10
10860009268606PhaseOne Antimicrobial Solution15235152352025-07-10
00860009268616PhaseOne Antimicrobial Solution15050150502025-07-10
10365197409300A+D Antimicrobial Hydrogel Spray86042409302025-06-10
20198715994272Advanced Scar & Wound Hydrogel86040860402025-05-07
20850015491782Rejuvacyn Plus Dermal Spray86037860372025-05-07
20850015491799Rejuvacyn Plus Dermal Spray86038860382025-05-07
20850015491805Rejuvacyn Plus Antipruritic Spray Gel86039860392025-05-07
20365197409000A+D Antimicrobial Hydrogel Spray86031409002025-04-04
20850015491751Ocucyn Eyelid & Eyelash Cleanser86026860262024-09-04
20850015491768Comfortcyn Advanced86027860272024-09-04
20850015491737Lumacyn86024860242024-06-27
20850034960009Dr. Burd's Wonder Spray86021860212023-09-07
20850034960016Dr. Burd's Wonder Spray86022860222023-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850087488006CeeportCEEPORT INC.FRO2026-05-22
10885632434266HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632468490HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632468506HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632468513HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632468520HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632509032HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632509049HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632509056HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632509063HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632510199HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
06977727072211Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072228Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072235Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072242Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072419SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072426SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072433SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072440SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
00050428339770CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-03-20
04719883980090Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980311Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980342Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980359Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980366Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980373Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980380Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980397Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
05060996770023AcutarexAlliance Healing Technologies, LLCFRO2026-03-13
00618474000169PuraPly Antimicrobial Wound MatrixORGANOGENESIS INC.FRO2026-03-12