DRMITSUI VAGINAL PROBIOTICS

Product NDC
85031-010
11-digit product format
850310010
Labeler code
85031
Product ID
85031-010_4f3e83a7-ebca-76e7-e063-6394a90a9e9e
Type
HUMAN OTC DRUG
Nonproprietary name
VAGINAL PROBIOTICS
Dosage form
GEL
Route
TOPICAL
Labeler
Guangzhou Zhuoyue Trading Co., Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-12
Substance
ROSA RUGOSA FLOWER BUD; CENTELLA ASIATICA ROOT; PORTULACA OLERACEA SEED
Active strength
5; 3; 3 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
DRMITSUI VAGINAL PROBIOTICS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSA RUGOSA FLOWER BUD5 g/100g
CENTELLA ASIATICA ROOT3 g/100g
PORTULACA OLERACEA SEED3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TZ0BE8I3MWInternal UNII lookup
8MXU1P42J0Internal UNII lookup
M08917G08ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4f3e83a7-ebc9-76e7-e063-6394a90a9e9eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85031-010-01DRMITSUI VAGINAL PROBIOTICS7 in 1 BOXGEL71
85031-010-01DRMITSUI VAGINAL PROBIOTICS3 g in 1 PATCHGEL31

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DRMITSUI VAGINAL PROBIOTICSVAGINAL PROBIOTICSGuangzhou Zhuoyue Trading Co., Ltd4f3e83a7-ebc9-76e7-e063-6394a90a9e9e2026-04-12WarningsExact identifier
ndc (product): 85031-010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85031-010-01850310010017 PATCH in 1 BOX (85031-010-01) / 3 g in 1 PATCH7 patch2026-04-12NoNoCurrent