Gembooxt Vaginal Probiotics Gel

Product NDC
76986-021
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
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR57ZHV85D4, P0M7O4Y7YD, 5NF60V72O5, CXS4LJR7EL

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76986-021-017698600210112 TUBE in 1 BOX (76986-021-01) / 3 g in 1 TUBE12 tube2025-12-19NoNoCurrent