FDA.reportPublic FDA data

HealQu Warm Therapy Gel

Product NDC
61577-4080
11-digit product format
615774080
Labeler code
61577
Product ID
61577-4080_a033b9ae-b187-7962-e053-2a95a90a3e25
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
2017-07-02
Marketing end
0000-00-00
Substance
MENTHOL; CAMPHOR (SYNTHETIC)
Active strength
0 g/g; 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
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-4080-12025-01-30C16284748780-19d75b9d0-6f7f-f424-e053-dadaa90a57ceHealQu Warm Therapy Gel
61577-4080-12023-03-09C16284748780-19d75b9d0-6f7f-f424-e053-dadaa90a57ceHealQu Warm Therapy Gel
61577-4080-12023-01-30C16284748780-19d75b9d0-6f7f-f424-e053-dadaa90a57ceHealQu Warm Therapy Gel
61577-4080-12020-03-06C16284748780-19d75b9d0-6f7f-f424-e053-dadaa90a57ceHealQu Warm Therapy Gel
61577-4080-12020-01-31C16284748780-19d75b9d0-6f7f-f424-e053-dadaa90a57ceHealQu Warm Therapy Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-4080-1HealQu Warm Therapy Gel226.8 g in 1 JARGEL226.84

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-4080HEALQU WARM THERAPY GEL (MENTHOL CAMPHOR) GEL [SOMBRA COSMETICS INC.]4Legacy NDC, 1 package rows20230311_63ac4535-2114-4f4f-83cf-0f88aeff511b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630714camphor 3 % / menthol 3 % Topical GelPSN63ac4535-2114-4f4f-83cf-0f88aeff511b4
1927297HEALQU warm therapy 3 % / 3 % Topical GelPSN63ac4535-2114-4f4f-83cf-0f88aeff511b4
1927297camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical Gel [Healqu]SBD63ac4535-2114-4f4f-83cf-0f88aeff511b4
630714camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical GelSCD63ac4535-2114-4f4f-83cf-0f88aeff511b4
630714camphor 3 % / menthol 3 % Topical GelSY63ac4535-2114-4f4f-83cf-0f88aeff511b4
1927297HealQu (camphor 3 % / menthol 3 % ) Topical GelSY63ac4535-2114-4f4f-83cf-0f88aeff511b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61577-4080-161577408001226.8 g in 1 JAR (61577-4080-1) 226.8 g2017-07-020000-00-00NoNoCurrent