LaBella Linimento Obrero

Product NDC
31774-8005
11-digit product format
317748005
Labeler code
31774
Product ID
31774-8005_12bf2514-2813-46c3-a3b4-c3425cbeb162
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin, Menthol, Unspecified Form, and Methyl Salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
Golden Sun Inc DBA Newhall Laboratories
Application
part346
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-01-02
Marketing end
0000-00-00
Substance
CAPSAICIN; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength
0 mg/mL; mg/mL; mg/mL
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
31774-8005-12020-01-31C16284748780-19d75b9d0-d702-f424-e053-dadaa90a57ceLaBella™ Linimento Obrero

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31774-8005-1LaBella Linimento Obrero236 mL in 1 BOTTLE, PLASTICCREAM2361

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CapsaicinACTIVE INGREDIENTS07O44R1ZMLABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]1
Menthol, Unspecified FormACTIVE INGREDIENTL7T10EIP3ALABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]1
Methyl SalicylateACTIVE INGREDIENTLAV5U5022YLABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]1
CapsaicinACTIVE MOIETYS07O44R1ZMLABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]1
Menthol, Unspecified FormACTIVE MOIETYL7T10EIP3ALABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]1
Salicylic AcidACTIVE MOIETYO414PZ4LPZLABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]1
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNLABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]1
Edetate SodiumINACTIVE INGREDIENTMP1J8420LULABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]1
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]1
Isopropyl PalmitateINACTIVE INGREDIENT8CRQ2TH63MLABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TLABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TLABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]1
Polysorbate 60INACTIVE INGREDIENTCAL22UVI4MLABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHLABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]1
Sorbitan SesquioleateINACTIVE INGREDIENT0W8RRI5W5ALABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APLABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]1
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YLABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]1
WaterINACTIVE INGREDIENT059QF0KO0RLABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31774-8005LABELLA LINIMENTO OBRERO (CAPSAICIN, MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE) CREAM [GOLDEN SUN INC DBA NEWHALL LABORATORIES]1Legacy NDC, 1 package rows20151110_fc5abe34-edf6-400a-bd28-1aea8bac8c70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1721014capsaicin 0.025 % / menthol 2 % / methyl salicylate 10 % Topical CreamPSNfc5abe34-edf6-400a-bd28-1aea8bac8c701
1721014capsaicin 0.25 MG/ML / menthol 20 MG/ML / methyl salicylate 100 MG/ML Topical CreamSCDfc5abe34-edf6-400a-bd28-1aea8bac8c701
1721014capsaicin 0.025 % / menthol 2 % / methyl salicylate 10 % Topical CreamSYfc5abe34-edf6-400a-bd28-1aea8bac8c701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
31774-8005-131774800501236 mL in 1 BOTTLE, PLASTIC236 mlHistorical