FDA.reportPublic FDA data

Terramed Just Think Comfort Yeast relief

Product NDC
83004-004
11-digit product format
830040004
Labeler code
83004
Product ID
83004-004_2efdee5b-13a6-6508-e063-6394a90a021d
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 Yeast relief
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
83004-004-012025-02-25C16284748780-12cef2736-5aec-d83d-e063-dadaa90ab31fDrug Facts
83004-004-012025-01-30C16284748780-12cef2736-5aec-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83004-004-01Terramed Just Think Comfort Yeast relief7 in 1 BOXGEL72
83004-004-01Terramed Just Think Comfort Yeast relief100 mL in 1 APPLICATORGEL1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83004-004TERRAMED JUST THINK COMFORT YEAST RELIEF (OLIVE EXTRACT,HYDRASTIS,BORAX,CALENDULA OFFICINALIS) GEL [RIDA LLC]2Current NDC, 2 package rows20250227_6112e199-b7dd-42e1-9004-f07a9bcd221d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83004-004-01830040004017 APPLICATOR in 1 BOX (83004-004-01) / 100 mL in 1 APPLICATOR7 applicator2023-11-11NoNoCurrent