FDA.reportPublic FDA data

HYDRADOSE

Primary DI
00860002995304
Brand
HYDRADOSE
Company
MD LABS LLC
Model
MD_01
Device description
HydraDose Vaginal Suppositories are a personal lubricant intended to moisturize the vaginal area and supplement the body's natural lubrication. Each box contains 10 individually packaged suppositories (2g each) containing Hyaluronic Acid Sodium Salt as the active ingredient. For vaginal use only.
Published
2026-08-01
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
true

Product Codes#

Code, Name table
CodeName
NUCLubricant, Personal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUCLubricant, PersonalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230518000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230518000HydraDose Vaginal SuppositoriesMD Labs, LLC2023-06-23NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860002995304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002995304008600029953048600029953040860002995304

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal pH suppositoryA device (tablet, capsule or ovule) intended to be inserted into the vagina where it dissolves to help normalize the vaginal environment and maintain a healthy vaginal flora. It may include acidic compounds, bacterial cultures (e.g. lactobacilli) and/or a prebiotic (e.g. lactose) intended to lower vaginal pH to an optimal range (usually pH 4 – 4.5) and/or help promote proliferation of normal vaginal bacteria (e.g., lactobacilli) and inhibition of harmful bacteria, which may prevent/treat bacterial vaginosis, candidiasis or urinary tract infections (UTI). It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. This is a single-use device.

Regulatory Flags#

DUNS number
123340634
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199874950815Hyaluronic Acid Vaginal Suppository (HA 10 mg)HUDI PHARMA SRLNUC2026-09-06
00796494750216LL Water-Based 5mLCC Wellness LLCNUC2026-09-04
00796494750223LL Water-Based 5mL Foil - 10pkCC Wellness LLCNUC2026-09-04
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00796494750247LL Silky Silicone 5mLCC Wellness LLCNUC2026-09-04
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00651277001681Cock Oil - Silicone 9ozCockOil LLCNUC2026-08-21
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