FDA.reportPublic FDA data

Terramed Just Think Comfort gyno care

Product NDC
83004-005
11-digit product format
830040005
Labeler code
83004
Product ID
83004-005_30032ab5-2ad8-9c06-e063-6294a90a8062
Type
HUMAN OTC DRUG
Nonproprietary name
Olive Extract,Hydrastis,Borax,Calendula Officinalis
Dosage form
GEL
Route
TOPICAL
Labeler
Rida LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-11-11
Substance
CALENDULA OFFICINALIS FLOWERING TOP; GOLDENSEAL; OLEUROPEIN; SODIUM BORATE
Active strength
1; 5; 3; 3 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Terramed Just Think Comfort gyno care
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]/100mL
GOLDENSEAL5 [hp_X]/100mL
OLEUROPEIN3 [hp_X]/100mL
SODIUM BORATE3 [hp_X]/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii18E7415PXQ, ZW3Z11D0JV, 2O4553545L, 91MBZ8H3QO

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83004-005-012025-03-10C16284748780-12cef2736-7aa2-d83d-e063-dadaa90ab31fDrug Facts
83004-005-012025-01-30C16284748780-12cef2736-7aa2-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83004-005-01Terramed Just Think Comfort gyno care100 mL in 1 APPLICATORGEL1003
83004-005-01Terramed Just Think Comfort gyno care7 in 1 BOXGEL73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83004-005TERRAMED JUST THINK COMFORT GYNO CARE (OLIVE EXTRACT,HYDRASTIS,BORAX,CALENDULA OFFICINALIS) GEL [RIDA LLC]3Current NDC, 2 package rows20250312_54b46411-0ff8-4b08-bf37-802b94acf5c1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83004-005-01830040005017 APPLICATOR in 1 BOX (83004-005-01) / 100 mL in 1 APPLICATOR7 applicator2023-11-11NoNoCurrent