FDA.reportPublic FDA data

Sombra Plus CBD 2000mg Warm Theapy

Product NDC
61577-7120
Requested package NDC
61577-7120-5
11-digit product format
615777120
Labeler code
61577
Product ID
61577-7120_d5c92f18-6d11-41f5-a386-ac8e62f15d60
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol Camphor
Dosage form
GEL
Route
TOPICAL
Labeler
Sombra Cosmetics INC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-05-24
Marketing end
0000-00-00
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
0 g/g; g/g
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage61577-712061577-7120-5IInactivated by FDA2026-10-12

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 · 9 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 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-7120-52025-01-30C16284748780-12cef2736-87db-d83d-e063-dadaa90ab31fSombra Plus 2000mg CBD Warm Therapy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-7120-5Sombra Plus CBD 2000mg Warm Theapy113.4 g in 1 BOTTLEGEL113.43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-7120SOMBRA PLUS CBD 2000MG WARM THEAPY (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC]3Legacy NDC, 1 package rows20220601_142d6c63-8823-441a-a4e1-64f3ee3fdab4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61577-7120-561577712005113.4 g in 1 BOTTLE (61577-7120-5) 113.4 g2022-05-240000-00-00NoNoCurrent