Hydro Gyn

Product NDC
85964-001
11-digit product format
859640001
Labeler code
85964
Product ID
85964-001_3bd3a52d-eb00-1c9f-e063-6394a90abbb6
Type
HUMAN OTC DRUG
Nonproprietary name
Calendula Offcianalis, Olive Extract
Dosage form
GEL
Route
CUTANEOUS
Labeler
Shenzhen water element e-commerce Co., LTD
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2025-08-08
Substance
CALENDULA OFFICINALIS FLOWERING TOP; OLEUROPEIN
Active strength
3; 3 [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydro Gyn
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]/mL
OLEUROPEIN3 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii18E7415PXQ, 2O4553545L

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85964-001-01Hydro Gyn10 mL in 1 BAGGEL101
85964-001-01Hydro Gyn10 in 1 BOXGEL101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85964-001-018596400010110 BAG in 1 BOX (85964-001-01) / 10 mL in 1 BAG10 bag2025-08-08NoNoHistorical