FDA.reportPublic FDA data

ORGANIC AND PLANT-BASED VULVOVAGINAL CARE

Product NDC
83385-001
11-digit product format
833850001
Labeler code
83385
Product ID
83385-001_3754fdee-f899-c507-e063-6394a90adffc
Type
HUMAN OTC DRUG
Nonproprietary name
Echinacea purpurea, Wood creosote, Thuja occidentalis leafy twig
Dosage form
SUPPOSITORY
Route
VAGINAL
Labeler
MOMOTARO APOTHECA LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2025-06-11
Substance
ECHINACEA PURPUREA; THUJA OCCIDENTALIS LEAFY TWIG; WOOD CREOSOTE
Active strength
12; 12; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ORGANIC AND PLANT-BASED VULVOVAGINAL CARE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ECHINACEA PURPUREA12 [hp_X]/1
THUJA OCCIDENTALIS LEAFY TWIG12 [hp_X]/1
WOOD CREOSOTE12 [hp_X]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQI7G114Y98, 1NT28V9397, 3JYG22FD73

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83385-001-01ORGANIC AND PLANT-BASED VULVOVAGINAL CARE1 in 1 PACKETSUPPOSITORY11
83385-001-01ORGANIC AND PLANT-BASED VULVOVAGINAL CARE14 in 1 CARTONSUPPOSITORY141
83385-001-02ORGANIC AND PLANT-BASED VULVOVAGINAL CARE1 in 1 PACKETSUPPOSITORY11
83385-001-02ORGANIC AND PLANT-BASED VULVOVAGINAL CARE3 in 1 POUCHSUPPOSITORY31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83385-001-018338500010114 PACKET in 1 CARTON (83385-001-01) / 1 SUPPOSITORY in 1 PACKET14 packet2025-06-11NoNoHistorical
83385-001-02833850001023 PACKET in 1 POUCH (83385-001-02) / 1 SUPPOSITORY in 1 PACKET3 packet2025-06-11NoNoHistorical