FDA.reportPublic FDA data

Dendracin Neurodendraxcin

Product NDC
63187-136
11-digit product format
631870136
Labeler code
63187
Product ID
63187-136_3d0f31a6-24a3-4f0b-939e-fffa9ee28a5b
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate, Menthol and Capsaicin
Dosage form
LOTION
Route
TOPICAL
Labeler
Proficient Rx LP
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-07-22
Substance
CAPSAICIN; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength
.015; 6; 18 g/60mL; g/60mL; g/60mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dendracin Neurodendraxcin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.015 g/60mL
MENTHOL, UNSPECIFIED FORM6 g/60mL
METHYL SALICYLATE18 g/60mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS07O44R1ZM, L7T10EIP3A, LAV5U5022Y
Rxcui1116967, 1116971

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
63187-136-022019-12-04C16284748780-19855e2a2-35eb-60a7-e053-dbdaa90a05bdDendracin Neurodendraxcin®, Topical Pain Relief Lotion
63187-136-042019-12-04C16284748780-19855e2a2-35eb-60a7-e053-dbdaa90a05bdDendracin Neurodendraxcin®, Topical Pain Relief Lotion
63187-136-022019-11-27C16284748780-19855e2a2-35eb-60a7-e053-dbdaa90a05bdDendracin Neurodendraxcin®, Topical Pain Relief Lotion
63187-136-042019-11-27C16284748780-19855e2a2-35eb-60a7-e053-dbdaa90a05bdDendracin Neurodendraxcin®, Topical Pain Relief Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-136-02Dendracin Neurodendraxcin50 in 1 CARTONLOTION504
63187-136-02Dendracin Neurodendraxcin60 mL in 1 BOTTLELOTION604
63187-136-04Dendracin Neurodendraxcin120 mL in 1 BOTTLELOTION1204
63187-136-04Dendracin Neurodendraxcin50 in 1 CARTONLOTION504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-136-04ML - Milliliter63187-136ffdba5f5-8a1a-4721-815c-f6af544e7d0e12015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZMDENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ADENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YDENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
CAPSAICINACTIVE MOIETYS07O44R1ZMDENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
MENTHOLACTIVE MOIETYL7T10EIP3ADENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZDENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XDENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
AMMONIO METHACRYLATE COPOLYMER TYPE AINACTIVE INGREDIENT8GQS4E66YYDENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
BENZOCAINEINACTIVE INGREDIENTU3RSY48JW5DENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
BORAGE OILINACTIVE INGREDIENTF8XAG1755SDENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNDENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
DIMETHYL SULFOXIDEINACTIVE INGREDIENTYOW8V9698HDENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWDENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
GINGERINACTIVE INGREDIENTC5529G5JPQDENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4DENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62DENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RDENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2DENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
SODIUM STEAROYL GLUTAMATEINACTIVE INGREDIENT65A9F4P024DENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKDENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RDENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-136DENDRACIN NEURODENDRAXCIN (METHYL SALICYLATE, MENTHOL AND CAPSAICIN) LOTION [PROFICIENT RX LP]4Current NDC, Legacy NDC, 4 package rows20240131_7e765fc1-74c6-4af3-a9cf-05b57011d7d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116967capsaicin 0.025 % / menthol 10 % / methyl salicylate 30 % Topical LotionPSN7e765fc1-74c6-4af3-a9cf-05b57011d7d84
1116971DENDRACIN Neurodendraxcin 0.025 % / 10 % / 30 % Topical LotionPSN7e765fc1-74c6-4af3-a9cf-05b57011d7d84
1116971capsaicin 0.25 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical Lotion [Dendracin Neurodendraxcin]SBD7e765fc1-74c6-4af3-a9cf-05b57011d7d84
1116967capsaicin 0.25 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical LotionSCD7e765fc1-74c6-4af3-a9cf-05b57011d7d84
1116967capsaicin 0.025 % / menthol 10 % / methyl salicylate 30 % Topical LotionSY7e765fc1-74c6-4af3-a9cf-05b57011d7d84
1116971Dendracin Neurodendraxcin (capsaicin 0.025 % / menthol 10 % / methyl salicylate 30 % ) Topical LotionSY7e765fc1-74c6-4af3-a9cf-05b57011d7d84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-136-026318701360250 BOTTLE in 1 CARTON (63187-136-02) / 60 mL in 1 BOTTLE50 bottle2014-08-010000-00-00NoNoCurrent
63187-136-046318701360450 BOTTLE in 1 CARTON (63187-136-04) / 120 mL in 1 BOTTLE50 bottle2014-08-010000-00-00NoNoCurrent