Sombra Plus CBD 500MG Cool Therapy

Product NDC
61577-7500
11-digit product format
615777500
Labeler code
61577
Product ID
61577-7500_f630c23a-5a68-466b-badd-fa8770c3d2e2
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
2020-11-03
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
0 g/g
NDC exclude flag
No
Listing certified through
2021-12-31
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
61577-7500-22024-01-30C16284748780-11030e365-5c79-111a-e063-dadaa90a10e2Sombra Plus CBD 500MG Cool Therapy
61577-7500-42024-01-30C16284748780-11030e365-5c79-111a-e063-dadaa90a10e2Sombra Plus CBD 500MG Cool Therapy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-7500-2Sombra Plus CBD 500MG Cool Therapy56.7 g in 1 JARGEL56.71
61577-7500-4Sombra Plus CBD 500MG Cool Therapy113.4 g in 1 JARGEL113.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-7500SOMBRA PLUS CBD 500MG COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]1Legacy NDC, 2 package rows20201106_d2695a6f-dc89-4173-b34c-ca1be89efe01.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61577-7500-26157775000256.7 g in 1 JAR (61577-7500-2) 56.7 g2020-11-030000-00-00NoNoCurrent
61577-7500-461577750004113.4 g in 1 JAR (61577-7500-4) 113.4 g2020-11-030000-00-00NoNoCurrent