FDA.reportPublic FDA data

REMEDI Health Solutions

Product NDC
59985-109
Requested package NDC
59985-109-12
11-digit product format
599850109
Labeler code
59985
Product ID
59985-109_2fef0a38-b87e-4d63-a476-10e7525124f6
Type
HUMAN OTC DRUG
Nonproprietary name
CALCAREA SULPHURICA, CALENDULA OFFICINALIS, GRAPHITES NATURALIS, NUX VOMICA, CRESOLUM, THUJA OCCIDENTALIS
Dosage form
CREAM
Route
TOPICAL
Labeler
Chc Montana
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-01-01
Marketing end
0000-00-00
Substance
CALCIUM SULFATE ANHYDROUS; CALENDULA OFFICINALIS FLOWERING TOP; GRAPHITE; STRYCHNOS NUX-VOMICA SEED; CRESOL; THUJA OCCIDENTALIS LEAFY TWIG
Active strength
30 [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g; [hp_C]/28g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59985-10959985-109-12DDiscontinued by firm2026-10-05

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, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59985-109-122024-12-03C16284748780-1f386c64a-3e6a-0266-e053-dadaa90a7c1aREMEDI Health Solutions-IRRITABLE SKIN Cream
59985-109-122023-01-30C16284748780-1f386c64a-3e6a-0266-e053-dadaa90a7c1aREMEDI Health Solutions-IRRITABLE SKIN Cream

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59985-109REMEDI HEALTH SOLUTIONS IRRITABLE SKIN CREAM (CALCAREA SULPHURICA, CALENDULA OFFICINALIS, GRAPHITES NATURALIS, NUX VOMICA, CRESOLUM, THUJA OCCIDENTALIS) CREAM [CHC MONTANA]4Legacy NDC20241205_5f94525f-7b4d-4f4e-981b-5ab646821d23.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59985-109-12599850109121 JAR in 1 BOX (59985-109-12) > 28 g in 1 JAR1 jar2019-01-010000-00-00NoNoCurrent