FDA.reportPublic FDA data

A+D Hydrogel Spray Advanced Dermatitis Care

Primary DI
00365197409204
Brand
A+D Hydrogel Spray Advanced Dermatitis Care
Company
Sonoma Pharmaceuticals, Inc.
Model
86046
Catalog number
40920
Published
2025-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
10365197409201PackageGS19In Commercial Distribution
20365197409208PackageGS14In Commercial Distribution
00365197409204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1036519740920110365197409201
2036519740920820365197409208
00365197409204003651974092043651974092040365197409204

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
Weight113Gram

Regulatory Flags#

DUNS number
081642964
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00365197409105A+D Antimicrobial Hydrogel86034409102026-05-25
00365197851003Bactine Antimicrobial Hydrogel Spray 86045851002026-01-16
10365197851000Bactine Antimicrobial Hydrogel Spray 86045851002026-01-16
00365197409402A+D Gentle Face Relief86049409402025-11-24
20365197409208A+D Hydrogel Spray Advanced Dermatitis Care86046409202025-11-24
20365197409406A+D Gentle Face Relief86049409402025-11-24
00850015491849Aquanil Repair Mist86050860502025-11-04
00850015491856Aquanil Repair Mist86051860512025-11-04
00850015491863Aquanil Rescue Serum86052860522025-11-04
00850015491870Aquanil Recovery Gel86053860532025-11-04
00850015491900Myze The Spray86057860572025-11-04
00365197760008Intimate Skin Cleansing Spray86048760002025-10-08
00365197760107Bikini Skin Soothing Gel86047760102025-10-08
00365197504107Solarcaine Advanced Burn Relief Hydrogel50410504102025-09-05
20365197504101Solarcaine Advanced Burn Relief Hydrogel50410504102025-09-05
00365197504008Solarcaine Advanced Burn Relief Hydrogel86035860352025-07-22
00365197851102Bactine Antimicrobial Wound Care Hydrogel86043860432025-07-22
20365197504002Solarcaine Advanced Burn Relief Hydrogel86035860352025-07-22
20365197851106Bactine Antimicrobial Wound Care Hydrogel86043860432025-07-22
00850015491832PhaseOne Antimicrobial Solution15473154732025-07-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00714196111050DermaRite Medical DermaHoney Medical Grade Honey 0.5 oz TubeSion Brands LLCFRO2026-06-01
00714196111074DermaRite Medical DermaHoney Medical Grade Honey 1.75 oz TubeSion Brands LLCFRO2026-06-01
01714196222045DermaRite Medical DermaHoney Tulle Non Border Honey Gauze 4x4Sion Brands LLCFRO2026-06-01
01714196333048DermaRite Medical DermaHoney Border Medical Grade Honey Sheet 4x4Sion Brands LLCFRO2026-06-01
08717249680130DermaRite Medical L-Mesitran 0.5 oz TubeSion Brands LLCFRO2026-06-01
08717249680147DermaRite Medical L-Mesitran 1.75 oz TubeSion Brands LLCFRO2026-06-01
00850087488259CeeportCEEPORT INC.FRO2026-05-29
00850087488266CeeportCEEPORT INC.FRO2026-05-29
10080196415397MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415386MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415393MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677289MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677296MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
00850087488006CeeportCEEPORT INC.FRO2026-05-22
10197344175994MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-20
10840330706688ProCureTwin Med, LLCFRO2026-05-04
00324357020451Zeni MedicalFocus Health Group, Inc.FRO2026-04-13
00324357020680Zeni MedicalFocus Health Group, Inc.FRO2026-04-13
00324357060440Zeni MedicalFocus Health Group, Inc.FRO2026-04-13
09551012610035ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610196ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610363ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610370ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
10192253046403KendallCardinal Health 200, LLCFRO2026-03-25
10192253046519KendallCardinal Health 200, LLCFRO2026-03-25
09120073781536GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781543GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10