Gembooxt Vaginal Probiotics Gel

Product NDC
76986-021
Requested package NDC
76986-021-02
11-digit product format
769860021
Labeler code
76986
Product ID
76986-021_464b0e4a-6d93-9a03-e063-6294a90a6ff4
Type
HUMAN OTC DRUG
Nonproprietary name
COPTIS CHINENSIS ROOT
Dosage form
GEL
Route
VAGINAL
Labeler
Guangdong Quadrant Ecological Technology Co., Ltd.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-19
Substance
BORIC ACID; CALENDULA OFFICINALIS FLOWER; CANARIUM ALBUM WHOLE; COPTIS CHINENSIS ROOT
Active strength
.03; .01; .03; .05 g/g; g/g; g/g; g/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gembooxt Vaginal Probiotics Gel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BORIC ACID.03 g/g
COPTIS CHINENSIS ROOT.01 g/g
CANARIUM ALBUM WHOLE.03 g/g
CALENDULA OFFICINALIS FLOWER.05 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R57ZHV85D4Internal UNII lookup
CXS4LJR7ELInternal UNII lookup
5NF60V72O5Internal UNII lookup
P0M7O4Y7YDInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
464b0e4a-6d92-9a03-e063-6294a90a6ff4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76986-021-01Gembooxt Vaginal Probiotics Gel3 g in 1 TUBEGEL31
76986-021-01Gembooxt Vaginal Probiotics Gel12 in 1 BOXGEL121

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
Gembooxt Vaginal Probiotics GelCOPTIS CHINENSIS ROOTGuangdong Quadrant Ecological Technology Co., Ltd.464b0e4a-6d92-9a03-e063-6294a90a6ff42026-07-09WarningsExact identifier
ndc (package): 76986-021-02
ndc (product): 76986-021
ndc11 (package): 76986002102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
76986-021-02769860021027 TUBE in 1 BOX (76986-021-02) / 3 g in 1 TUBE7 tube2025-12-190Current