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
METHYL SALICYLATE; MENTHOL, UNSPECIFIED FORM; CAPSAICIN
Active strength
18; 6; .015 g/60mL; g/60mL; g/60mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Dendracin Neurodendraxcin
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
L7T10EIP3AInternal UNII lookup
S07O44R1ZMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1116967Internal RxNorm lookup
1116971Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7e765fc1-74c6-4af3-a9cf-05b57011d7d8Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63187-136-022019-12-04Dendracin Neurodendraxcin®, Topical Pain Relief Lotion
63187-136-042019-12-04Dendracin Neurodendraxcin®, Topical Pain Relief Lotion
63187-136-022019-11-27Dendracin Neurodendraxcin®, Topical Pain Relief Lotion
63187-136-042019-11-27Dendracin 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 8 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine 4% PatchLIDOCAINEAldermed Inc.57994923-20fc-9d9d-e063-6394a90a22c92026-07-27WarningsExact identifier
application number: M017
Lidocaine 4% PatchLIDOCAINEAldermed Inc.579a5012-837a-828b-e063-6294a90a4fb22026-07-27WarningsExact identifier
application number: M017
Original Pain ReliefTOPICAL ANALGESIC LOTIONReal Time Pain Relief Inc579bd303-9a50-4d66-e063-6294a90a61412026-07-27WarningsExact identifier
application number: M017
Lidfix Pain Relief Patch LidocaineLIDOCAINEHETERO HEALTHCARE LIMITED2149f0e3-1983-4f02-929e-ecd20357f4bb2026-07-27WarningsExact identifier
application number: M017
RectoProtectLIDOCAINEAkron Pharma Inc.1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb2026-07-27WarningsExact identifier
application number: M017
OWELL NATURALS MAXIMUM STRENGTH LEG PAIN RELIEFMENTHOLOWELL NATURAL 8 LLC57a124b4-66c6-2474-e063-6294a90ab0d72026-07-27WarningsExact identifier
application number: M017
Icy Hot Performance DryMENTHOL 16%, CAMPHOR 11%Chattem, Inc.8927570f-761b-4d83-8612-30077224fdb82026-07-27WarningsExact identifier
application number: M017
NUMBINGLIDOCAINEYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED578675e8-30e7-6986-e063-6394a90a8afe2026-07-26WarningsExact identifier
application number: M017
Do Me Delay CreamBENZOCAINEProdigy Media53d5cd6b-96b8-9ba2-e063-6294a90a0d152026-07-24WarningsExact identifier
application number: M017
Bravado Labs Delay CreamBENZOCAINEProdigy Media Inc57269544-9cfb-4ff0-e063-6394a90adb022026-07-24WarningsExact identifier
application number: M017
Zytherial Lidocaine 4% Pain Relief PatchLIDOCAINE 4% PAIN RELIEF PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.56db5028-b631-7981-e063-6294a90ae3952026-07-24WarningsExact identifier
application number: M017
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCf8fa72db-5f7a-4158-a2b3-f8bc0e12df9f2026-07-24WarningsExact identifier
application number: M017
AEROSOOTHEHYDROCORTISONEAero Healthcare US LLC22b172a2-07e8-4ebb-b0a0-dfe4f25477fa2026-07-24WarningsExact identifier
application number: M017
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
application number: M017
Arlun Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5765fbf1-e835-a11e-e063-6394a90a5ac22026-07-24WarningsExact identifier
application number: M017
DERMFREE PAIN RELIEFARNICA MONTANA HPUS 7% PAIN RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4bb74112-c4e7-7988-e063-6394a90ae3f12026-07-24WarningsExact identifier
application number: M017
SERYNTH HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4c667f3d-1238-2f02-e063-6394a90ab7422026-07-24WarningsExact identifier
application number: M017
DERMFREE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4ca7222b-d754-9861-e063-6294a90a1b7b2026-07-24WarningsExact identifier
application number: M017
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG CAPSICUM EXTRACT 16MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4ca7d0ca-6407-1fed-e063-6394a90aaccc2026-07-24WarningsExact identifier
application number: M017
SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AIDNICOTINE21MG NICOTINE TRANSDERMAL STOP SMOKING AIDJiangxi Yudexi Pharmaceutical Co., LTD4d5821f9-605e-5391-e063-6294a90afcd22026-07-24WarningsExact identifier
application number: M017

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