Terramed Just Think Comfort Yeast relief

Product NDC
83004-004
Requested package NDC
83004-004-01
11-digit product format
830040004
Labeler code
83004
Product ID
83004-004_5dfa23f6-1e99-9f58-e063-6294a90a95ce
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
OLEUROPEIN; GOLDENSEAL; SODIUM BORATE; CALENDULA OFFICINALIS FLOWERING TOP
Active strength
3; 5; 3; 1 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage83004-00483004-004-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage83004-00483004-004-01UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage83004-00483004-004-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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 Yeast relief
Listing expiration
2027-12-31

Active Ingredients#

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

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2025-02-25Drug Facts
2025-02-25Drug Facts
2025-01-30Drug Facts
2025-01-30Drug 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