Home NDC 83004-046 Terramed Just Think Comfort GynoCare BV Guard Vaginal Symptoms Relief
Product NDC 83004-046
11-digit product format 830040046
Labeler code 83004
Product ID 83004-046_563141e4-6d00-0caa-e063-6394a90ac241
Type HUMAN OTC DRUG
Nonproprietary name Olive Extract,Hydrastis,Borax,Calendula Officinalis
Dosage form GEL
Route VAGINAL
Labeler Rida LLC
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2024-12-12
Substance OLEA EUROPAEA (OLIVE) LEAF POWDER; GOLDENSEAL; SODIUM BORATE; CALENDULA OFFICINALIS FLOWERING TOP
Active strength 3; 5; 3; 1 [hp_X]/8.5g; [hp_X]/8.5g; [hp_X]/8.5g; [hp_X]/8.5g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Terramed Just Think Comfort GynoCare BV Guard Vaginal Symptoms Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLEA EUROPAEA (OLIVE) LEAF POWDER 3 [hp_X]/8.5g GOLDENSEAL 5 [hp_X]/8.5g SODIUM BORATE 3 [hp_X]/8.5g CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X]/8.5g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83004-046-01 83004004601 7 APPLICATOR in 1 BOX (83004-046-01) / 8.5 g in 1 APPLICATOR 7 applicator 2024-12-12 No No Current 83004-046-02 83004004602 20 APPLICATOR in 1 BOX (83004-046-02) / 8.5 g in 1 APPLICATOR 20 applicator 2024-12-12 No No Current