FDA.reportPublic FDA data

Terramed Just Think Comfort Hydro

Product NDC
83004-006
11-digit product format
830040006
Labeler code
83004
Product ID
83004-006_300331c2-b26c-179a-e063-6394a90aabe8
Type
HUMAN OTC DRUG
Nonproprietary name
Olive Extract,Calendula Officinalis
Dosage form
GEL
Route
TOPICAL
Labeler
Rida LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-11-11
Substance
CALENDULA OFFICINALIS FLOWERING TOP; OLEUROPEIN
Active strength
3; 3 [hp_X]/100mL; [hp_X]/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct83004-006DDiscontinued by firm2026-08-11
excluded packagepackage83004-00683004-006-01DDiscontinued by firm2026-08-11

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage83004-006-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage83004-006-01UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage83004-006-01UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage83004-006-01UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
83004-006-012025-03-10C16284748780-12cef2736-abda-d83d-e063-dadaa90ab31fDrug Facts
83004-006-012025-01-30C16284748780-12cef2736-abda-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83004-006-01Terramed Just Think Comfort Hydro10 in 1 BOXGEL103
83004-006-01Terramed Just Think Comfort Hydro100 mL in 1 APPLICATORGEL1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83004-006TERRAMED JUST THINK COMFORT HYDRO (OLIVE EXTRACT,CALENDULA OFFICINALIS) GEL [RIDA LLC]3Current NDC, 2 package rows20250312_43505966-6131-459a-9858-aaeb25cdd7dd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83004-006-018300400060110 APPLICATOR in 1 BOX (83004-006-01) / 100 mL in 1 APPLICATOR10 applicator2023-11-11NoNoHistorical