FDA.reportPublic FDA data

Simanix

Product NDC
69379-013
11-digit product format
693790013
Labeler code
69379
Product ID
69379-013_1a4dfef7-a7ad-2142-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simanix Pain Relieving Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Home Aide Diagnostics, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2015-07-08
Marketing end
0000-00-00
Substance
CAPSAICIN; MENTHOL; HISTAMINE DIHYDROCHLORIDE
Active strength
0 g/100g; g/100g; g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
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
69379-013-022020-01-31C16284748780-19d75b9d0-f73f-f424-e053-dadaa90a57ceSilmanix Pain Relieiving Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69379-013-02Simanix120 g in 1 BOTTLECREAM1202

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZMSIMANIX (SIMANIX PAIN RELIEVING CREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]2
HISTAMINE DIHYDROCHLORIDEACTIVE INGREDIENT3POA0Q644USIMANIX (SIMANIX PAIN RELIEVING CREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]2
MENTHOLACTIVE INGREDIENTL7T10EIP3ASIMANIX (SIMANIX PAIN RELIEVING CREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]2
CAPSAICINACTIVE MOIETYS07O44R1ZMSIMANIX (SIMANIX PAIN RELIEVING CREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]2
HISTAMINEACTIVE MOIETY820484N8I3SIMANIX (SIMANIX PAIN RELIEVING CREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]2
MENTHOLACTIVE MOIETYL7T10EIP3ASIMANIX (SIMANIX PAIN RELIEVING CREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69379-013SIMANIX (SIMANIX PAIN RELIEVING CREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.]2Legacy NDC, 1 package rows20150708_1a4dfef7-a7ac-2142-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656333capsaicin 0.0375 % / menthol 3 % / histamine dihydrochloride 0.035 % Topical CreamPSN1a4dfef7-a7ac-2142-e054-00144ff8d46c2
1656333capsaicin 0.375 MG/ML / histamine dihydrochloride 0.35 MG/ML / menthol 30 MG/ML Topical CreamSCD1a4dfef7-a7ac-2142-e054-00144ff8d46c2
1656333capsaicin 0.0375 % / histamine dihydrochloride 0.035 % / menthol 3 % Topical CreamSY1a4dfef7-a7ac-2142-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69379-013-0269379001302120 g in 1 BOTTLE120 gHistorical