OPITOX TOPICAL

Product NDC
72380-521
11-digit product format
723800521
Labeler code
72380
Product ID
72380-521_33849afb-7b97-49fb-b2c2-bd98f13fcacc
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL CAMPHOR
Dosage form
GEL
Route
TOPICAL
Labeler
Vivera Pharmaceuticals, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-08-06
Marketing end
0000-00-00
Substance
MENTHOL; CAMPHOR (SYNTHETIC)
Active strength
4 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2020-12-31
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
72380-521-102022-01-28C16284748780-1d6a99b39-d2b4-a426-e053-dadaa90af4c2OPITOX TOPICAL GEL PAIN RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72380-521-10OPITOX TOPICALGel1 in 1 BOXGEL11
72380-521-10OPITOX TOPICALGel88.7 mL in 1 TUBEGEL88.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72380-521OPITOX TOPICAL GEL (MENTHOL CAMPHOR) GEL [VIVERA PHARMACEUTICALS, INC.]1Legacy NDC, 2 package rows20191206_cb3de61a-b0b1-443b-8c11-438753ecb87a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416207camphor 0.2 % / menthol 3.5 % Topical GelPSNcb3de61a-b0b1-443b-8c11-438753ecb87a1
416207camphor 0.002 MG/MG / menthol 0.035 MG/MG Topical GelSCDcb3de61a-b0b1-443b-8c11-438753ecb87a1
416207camphor 0.2 % / menthol 3.5 % Topical GelSYcb3de61a-b0b1-443b-8c11-438753ecb87a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72380-521-10723800521101 TUBE in 1 BOX (72380-521-10) > 88.7 mL in 1 TUBE1 tube2019-08-060000-00-00NoNoCurrent