PURE EASE Neur Cream Instant Deep Pain Relief

Product NDC
83676-436
11-digit product format
836760436
Labeler code
83676
Product ID
83676-436_0a0641ca-08cd-ad95-e063-6394a90af331
Type
HUMAN OTC DRUG
Nonproprietary name
CAPSAICIN, MENTHOL
Dosage form
CREAM
Route
TOPICAL
Labeler
SERENU, INC.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-27
Substance
CAPSAICIN; MENTHOL
Active strength
.25; 80 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PURE EASE Neur Cream Instant Deep Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.25 mg/mL
MENTHOL80 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS07O44R1ZM, L7T10EIP3A

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83676-436-00PURE EASE Neur Cream Instant Deep Pain Relief60 mL in 1 JARCREAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83676-436PURE EASE NEUR CREAM INSTANT DEEP PAIN RELIEF (CAPSAICIN, MENTHOL) CREAM [SERENU, INC.]1Current NDC, 1 package rows20231128_e46a4636-6405-440a-a05a-862c354bab54.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83676-436-008367604360060 mL in 1 JAR (83676-436-00) 60 ml2023-11-27NoNoHistorical