FDA.reportPublic FDA data

TERRAMED JUST THINK COMFORT GYNOCARE FOR BACTERIAL VAGINOSIS SYMPTOMS RELIEF

Product NDC
83004-041
Requested package NDC
83004-041-01
11-digit product format
830040041
Labeler code
83004
Product ID
83004-041_53c16e2b-7590-acc3-e063-6294a90a795a
Type
HUMAN OTC DRUG
Nonproprietary name
sodium borate,calendula officinalis flowering top,goldenseal,olea europaea olive leaf powder
Dosage form
SUPPOSITORY
Route
VAGINAL
Labeler
Rida LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-12-12
Substance
SODIUM BORATE; CALENDULA OFFICINALIS FLOWERING TOP; GOLDENSEAL; OLEA EUROPAEA (OLIVE) LEAF POWDER
Active strength
3; 1; 5; 3 [hp_X]/2g; [hp_X]/2g; [hp_X]/2g; [hp_X]/2g
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 FOR BACTERIAL VAGINOSIS SYMPTOMS RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM BORATE3 [hp_X]/2g
CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]/2g
GOLDENSEAL5 [hp_X]/2g
OLEA EUROPAEA (OLIVE) LEAF POWDER3 [hp_X]/2g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1625d88d-5ac8-492a-a152-3047d168575aAvailable 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 FOR BACTERIAL VAGINOSIS SYMPTOMS RELIEFSODIUM BORATE,CALENDULA OFFICINALIS FLOWERING TOP,GOLDENSEAL,OLEA EUROPAEA OLIVE LEAF POWDERRida LLC1625d88d-5ac8-492a-a152-3047d168575a2026-06-08WarningsExact identifier
ndc (package): 83004-041-01
ndc (product): 83004-041
ndc11 (package): 83004004101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83004-041-018300400410112 BLISTER PACK in 1 CARTON (83004-041-01) / 2 g in 1 BLISTER PACK12 blister pack2024-12-12NoNoCurrent