REMEDI Health Solutions

Product NDC
59985-305
11-digit product format
599850305
Labeler code
59985
Product ID
59985-305_5634627d-5d74-4b7c-87bc-7f0820e65fd0
Type
HUMAN OTC DRUG
Nonproprietary name
CALENDULA OFFICINALIS, CAPSICUM ANNUUM, CANTHARIS VESICATORIA, UTRICA URENS
Dosage form
SPRAY
Route
ORAL; TOPICAL
Labeler
Chc Montana
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-01-01
Marketing end
0000-00-00
Substance
CALENDULA OFFICINALIS FLOWERING TOP; CAPSICUM ANNUUM WHOLE; LYTTA VESICATORIA; URTICA URENS WHOLE
Active strength
30 [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_C]/30mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59985-305DDiscontinued by firm2026-10-12
excluded packagepackage59985-30559985-305-32DDiscontinued by firm2026-10-12

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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59985-305-32DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59985-305-32DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59985-305-32IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59985-305-32IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59985-305-32IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage59985-305-32IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage59985-305-32IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage59985-305-32IInactivated 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
59985-305-322024-12-03C16284748780-1f386c64a-0a6b-0266-e053-dadaa90a7c1aREMEDI Health Solutions-BURN RELIEF
59985-305-322023-01-30C16284748780-1f386c64a-0a6b-0266-e053-dadaa90a7c1aREMEDI Health Solutions-BURN RELIEF

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59985-305REMEDI HEALTH SOLUTIONS BURN RELIEF (CALENDULA OFFICINALIS, CAPSICUM ANNUUM, CANTHARIS VESICATORIA, UTRICA URENS) SPRAY [CHC MONTANA]4Legacy NDC20241205_331f9562-c4df-48fd-a512-d016570b6da2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59985-305-32599850305321 BOTTLE, SPRAY in 1 BOX (59985-305-32) > 30 mL in 1 BOTTLE, SPRAY2019-01-010000-00-00NoNoCurrent