BRONSON SOOTHE Pain Relief

Product NDC
83158-387
11-digit product format
831580387
Labeler code
83158
Product ID
83158-387_0976edf3-b97e-fff9-e063-6294a90a2c4e
Type
HUMAN OTC DRUG
Nonproprietary name
CAPSAICIN
Dosage form
CREAM
Route
TOPICAL
Labeler
BRONSON NUTRITIONALS, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-26
Substance
CAPSAICIN
Active strength
.25 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
BRONSON SOOTHE Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS07O44R1ZM
Rxcui198555

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83158-387-02BRONSON SOOTHE Pain Relief59 mL in 1 TUBECREAM592
83158-387-04BRONSON SOOTHE Pain Relief118 mL in 1 TUBECREAM1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83158-387BRONSON SOOTHE PAIN RELIEF (CAPSAICIN) CREAM [BRONSON NUTRITIONALS, LLC]2Current NDC, Legacy NDC, 2 package rows20231106_cedf8f43-b9a3-4a06-b3a1-cf82668541f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198555capsaicin 0.025 % Topical CreamPSNcedf8f43-b9a3-4a06-b3a1-cf82668541f82
198555capsaicin 0.25 MG/ML Topical CreamSCDcedf8f43-b9a3-4a06-b3a1-cf82668541f82
198555capsaicin 0.025 % Topical CreamSYcedf8f43-b9a3-4a06-b3a1-cf82668541f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83158-387-028315803870259 mL in 1 TUBE (83158-387-02) 59 ml2022-12-260000-00-00NoNoCurrent
83158-387-0483158038704118 mL in 1 TUBE (83158-387-04) 118 ml2022-12-260000-00-00NoNoCurrent