FDA.reportPublic FDA data

Olive Vaginal Formula

Product NDC
64616-055
11-digit product format
646160055
Labeler code
64616
Product ID
64616-055_462ed926-b477-4f8d-e063-6294a90af65e
Type
HUMAN OTC DRUG
Nonproprietary name
Olive Leaf Vaginal Spray
Dosage form
SPRAY
Route
VAGINAL
Labeler
Vitality Works, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2010-02-10
Substance
CHAMAELIRIUM LUTEUM ROOT; PLATINUM; SODIUM BORATE; WOOD CREOSOTE
Active strength
8; 12; 8; 12 [hp_X]/mL; [hp_X]/mL; [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
Olive Vaginal Formula
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHAMAELIRIUM LUTEUM ROOT8 [hp_X]/mL
PLATINUM12 [hp_X]/mL
SODIUM BORATE8 [hp_X]/mL
WOOD CREOSOTE12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDQV54Y5H3U, 49DFR088MY, 91MBZ8H3QO, 3JYG22FD73

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
64616-055-01Olive Vaginal Formula30 mL in 1 BOTTLE, PLASTICSPRAY309
64616-055-02Olive Vaginal Formula1 in 1 CARTONSPRAY19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHAMAELIRIUM LUTEUM ROOTACTIVE INGREDIENTDQV54Y5H3UOLIVE VAGINAL FORMULA (OLIVE LEAF VAGINAL SPRAY) SPRAY [VITALITY WORKS, INC]2
PLATINUMACTIVE INGREDIENT49DFR088MYOLIVE VAGINAL FORMULA (OLIVE LEAF VAGINAL SPRAY) SPRAY [VITALITY WORKS, INC]2
SODIUM BORATEACTIVE INGREDIENT91MBZ8H3QOOLIVE VAGINAL FORMULA (OLIVE LEAF VAGINAL SPRAY) SPRAY [VITALITY WORKS, INC]2
WOOD CREOSOTEACTIVE INGREDIENT3JYG22FD73OLIVE VAGINAL FORMULA (OLIVE LEAF VAGINAL SPRAY) SPRAY [VITALITY WORKS, INC]2
BORATE IONACTIVE MOIETY44OAE30D22OLIVE VAGINAL FORMULA (OLIVE LEAF VAGINAL SPRAY) SPRAY [VITALITY WORKS, INC]2
CHAMAELIRIUM LUTEUM ROOTACTIVE MOIETYDQV54Y5H3UOLIVE VAGINAL FORMULA (OLIVE LEAF VAGINAL SPRAY) SPRAY [VITALITY WORKS, INC]2
PLATINUMACTIVE MOIETY49DFR088MYOLIVE VAGINAL FORMULA (OLIVE LEAF VAGINAL SPRAY) SPRAY [VITALITY WORKS, INC]2
WOOD CREOSOTEACTIVE MOIETY3JYG22FD73OLIVE VAGINAL FORMULA (OLIVE LEAF VAGINAL SPRAY) SPRAY [VITALITY WORKS, INC]2
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1OLIVE VAGINAL FORMULA (OLIVE LEAF VAGINAL SPRAY) SPRAY [VITALITY WORKS, INC]2
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LOLIVE VAGINAL FORMULA (OLIVE LEAF VAGINAL SPRAY) SPRAY [VITALITY WORKS, INC]2
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EOLIVE VAGINAL FORMULA (OLIVE LEAF VAGINAL SPRAY) SPRAY [VITALITY WORKS, INC]2
SHARK LIVER OILINACTIVE INGREDIENT4B24275HEUOLIVE VAGINAL FORMULA (OLIVE LEAF VAGINAL SPRAY) SPRAY [VITALITY WORKS, INC]2
VANILLAINACTIVE INGREDIENTQ74T35078HOLIVE VAGINAL FORMULA (OLIVE LEAF VAGINAL SPRAY) SPRAY [VITALITY WORKS, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-055OLIVE VAGINAL FORMULA (OLIVE LEAF VAGINAL SPRAY) SPRAY [VITALITY WORKS, INC]8Current NDC, Legacy NDC, 2 package rows20241212_79911273-61f1-4cba-ac41-b2612657063b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64616-055-016461600550130 mL in 1 BOTTLE, PLASTIC30 mlHistorical
64616-055-02646160055021 BOTTLE, PLASTIC in 1 CARTON (64616-055-02) / 30 mL in 1 BOTTLE, PLASTIC (64616-055-01) 2010-02-100000-00-00NoNoCurrent