FDA.reportPublic FDA data

Precilyx Vaginal Probiotics Gel

Product NDC
76986-017
11-digit product format
769860017
Labeler code
76986
Product ID
76986-017_4686ecc6-f1f3-4468-e063-6294a90afba5
Type
HUMAN OTC DRUG
Nonproprietary name
COPTIS CHINENSIS ROOT, BORIC ACID, CANARIUM ALBUM WHOLE, CALENDULA OFFICINALIS FLOWER
Dosage form
GEL
Route
VAGINAL
Labeler
Guangdong Quadrant Ecological Technology Co., Ltd.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-11
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
Precilyx 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
76986-017-01Precilyx Vaginal Probiotics Gel3 g in 1 TUBEGEL33
76986-017-01Precilyx Vaginal Probiotics Gel7 in 1 BOXGEL73
76986-017-02Precilyx Vaginal Probiotics Gel3 g in 1 TUBEGEL33
76986-017-02Precilyx Vaginal Probiotics Gel14 in 1 BOXGEL143

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76986-017-01769860017017 TUBE in 1 BOX (76986-017-01) / 3 g in 1 TUBE7 tube2025-12-11NoNoCurrent
76986-017-027698600170214 TUBE in 1 BOX (76986-017-02) / 3 g in 1 TUBE14 tube2025-12-11NoNoCurrent