FDA.reportPublic FDA data

Terramed Just Think Comfort GynoCare BV Guard Vaginal Symptoms Relief

Product NDC
83004-046
Requested package NDC
83004-046-02
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
IngredientStrength
OLEA EUROPAEA (OLIVE) LEAF POWDER3 [hp_X]/8.5g
GOLDENSEAL5 [hp_X]/8.5g
SODIUM BORATE3 [hp_X]/8.5g
CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]/8.5g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MJ95C3OH47Internal UNII lookup
ZW3Z11D0JVInternal UNII lookup
91MBZ8H3QOInternal UNII lookup
18E7415PXQInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5c42c8ae-3610-4fc9-b764-ccf22340d9ceAvailable on FDA.report

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Terramed Just Think Comfort GynoCare BV Guard Vaginal Symptoms ReliefOLIVE EXTRACT,HYDRASTIS,BORAX,CALENDULA OFFICINALISRida LLC5c42c8ae-3610-4fc9-b764-ccf22340d9ce2026-07-09WarningsExact identifier
ndc (package): 83004-046-02
ndc (product): 83004-046
ndc11 (package): 83004004602

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83004-046-028300400460220 APPLICATOR in 1 BOX (83004-046-02) / 8.5 g in 1 APPLICATOR20 applicator2024-12-12NoNoCurrent