SOMBRA PLUS CBD 1000MG COOL THERAPY

Product NDC
61577-7100
11-digit product format
615777100
Labeler code
61577
Product ID
61577-7100_253162ce-6b3d-4502-8ad3-2f4964f9cd61
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Sombra Cosmetics Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-05-20
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
0 g/g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-7100-22025-01-30C16284748780-12cef2736-a12a-d83d-e063-dadaa90ab31fSombra Plux CBD 1000mg Cool Therapy
61577-7100-42025-01-30C16284748780-12cef2736-a12a-d83d-e063-dadaa90ab31fSombra Plux CBD 1000mg Cool Therapy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-7100-2SOMBRA PLUS CBD 1000MG COOL THERAPY56.7 g in 1 JARGEL56.72
61577-7100-4SOMBRA PLUS CBD 1000MG COOL THERAPY113.4 g in 1 JARGEL113.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-7100SOMBRA PLUS CBD 1000MG COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]2Legacy NDC, 2 package rows20220521_ca0b28e8-c25f-4414-9345-ea3c2dc0a436.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61577-7100-26157771000256.7 g in 1 JAR (61577-7100-2) 56.7 g2022-05-200000-00-00NoNoCurrent
61577-7100-461577710004113.4 g in 1 JAR (61577-7100-4) 113.4 g2022-05-200000-00-00NoNoCurrent