FDA.reportPublic FDA data

Terramed Just Think Comfort Homeopathic Drug HydroGyn Vaginal Moisturizer

Product NDC
83004-047
Requested package NDC
83004-047-01
11-digit product format
830040047
Labeler code
83004
Product ID
83004-047_56314dd6-29b6-4b61-e063-6294a90abeab
Type
HUMAN OTC DRUG
Nonproprietary name
sepia officinalis ink, calendula officinalis flowering top
Dosage form
GEL
Route
VAGINAL
Labeler
Rida LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-04-10
Substance
SEPIA OFFICINALIS JUICE; CALENDULA OFFICINALIS FLOWERING TOP
Active strength
6; 3 [hp_X]/1.13g; [hp_X]/1.13g
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 Homeopathic Drug HydroGyn Vaginal Moisturizer
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEPIA OFFICINALIS JUICE6 [hp_X]/1.13g
CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]/1.13g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QDL83WN8C2Internal 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
dc682cb4-231e-4a8f-a0d0-fe4f07ad064dAvailable 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 Homeopathic Drug HydroGyn Vaginal MoisturizerSEPIA OFFICINALIS INK, CALENDULA OFFICINALIS FLOWERING TOPRida LLCdc682cb4-231e-4a8f-a0d0-fe4f07ad064d2026-07-09WarningsExact identifier
ndc (package): 83004-047-01
ndc (product): 83004-047
ndc11 (package): 83004004701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83004-047-01830040047013 APPLICATOR in 1 BOX (83004-047-01) / 1.13 g in 1 APPLICATOR3 applicator2026-04-10NoNoCurrent