FDA.reportPublic FDA data

Bactine Antimicrobial Wound Care Hydrogel

Primary DI
20365197851106
Brand
Bactine Antimicrobial Wound Care Hydrogel
Company
Sonoma Pharmaceuticals, Inc.
Model
86043
Catalog number
86043
Published
2025-07-22
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10365197851109PackageGS18In Commercial Distribution
20365197851106PackageGS13In Commercial Distribution
00365197851102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1036519785110910365197851109
2036519785110620365197851106
00365197851102003651978511023651978511020365197851102

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
Weight227Gram

Sterilization Methods#

Method table
Method

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
00365197409105A+D Antimicrobial Hydrogel86034409102026-05-25
00365197851003Bactine Antimicrobial Hydrogel Spray 86045851002026-01-16
10365197851000Bactine Antimicrobial Hydrogel Spray 86045851002026-01-16
00365197409204A+D Hydrogel Spray Advanced Dermatitis Care86046409202025-11-24
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
00850015491832PhaseOne Antimicrobial Solution15473154732025-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00050428280669CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-06-04
00050428453599CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-06-04
50192253067901ASOCardinal Health 200, LLCFRO2026-06-03
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