FDA.reportPublic FDA data

DermacinRx Penetral Cream

Product NDC
59088-310
11-digit product format
590880310
Labeler code
59088
Product ID
59088-310_238446ea-9fd0-9e67-e063-6394a90a9f52
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin
Dosage form
CREAM
Route
TOPICAL
Labeler
PureTek Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-09
Substance
CAPSICUM OLEORESIN
Active strength
.25 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
DermacinRx Penetral Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSICUM OLEORESIN.25 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
UW86K581WYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198555Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1e343a52-6071-3230-e054-00144ff8d46cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-310-08DermacinRx Penetral Cream118 mL in 1 BOTTLE, PUMPCREAM1186
59088-310-16DermacinRx Penetral Cream237 mL in 1 BOTTLE, PUMPCREAM2376

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-310-08ML - Milliliter59088-31062c92dad-6454-4352-970c-42700b8b595612021-11-09
59088-310-16ML - Milliliter59088-3103b67732f-9da0-4073-8393-932730657a4512020-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSICUM OLEORESINACTIVE INGREDIENTUW86K581WYDERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]1
CAPSICUM OLEORESINACTIVE INGREDIENTUW86K581WYDERMACINRX LEXITRAL PHARMAPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]1
Diclofenac SodiumACTIVE INGREDIENTQTG126297QDERMACINRX LEXITRAL PHARMAPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]1
CAPSICUM OLEORESINACTIVE MOIETYUW86K581WYDERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]1
CAPSICUM OLEORESINACTIVE MOIETYUW86K581WYDERMACINRX LEXITRAL PHARMAPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]1
DiclofenacACTIVE MOIETY144O8QL0L1DERMACINRX LEXITRAL PHARMAPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MDERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]1
alcoholINACTIVE INGREDIENT3K9958V90MDERMACINRX LEXITRAL PHARMAPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XDERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]1
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZDERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]1
CARBOMER INTERPOLYMER TYPE A (55000 CPS)INACTIVE INGREDIENT59TL3WG5CODERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]1
dimethyl sulfoxideINACTIVE INGREDIENTYOW8V9698HDERMACINRX LEXITRAL PHARMAPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]1
ETHYL MENTHANE CARBOXAMIDEINACTIVE INGREDIENT6S7S02945HDERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PDERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]1
EUTERPE OLERACEA WHOLEINACTIVE INGREDIENTY57H6218HPDERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]1
FLAX SEEDINACTIVE INGREDIENT4110YT348CDERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXDERMACINRX LEXITRAL PHARMAPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]1
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDEINACTIVE INGREDIENT9CO8OUL4THDERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]1
LAURYL LAURATEINACTIVE INGREDIENTGPW77G0937DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]1
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7IDERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]1
METHYL DIISOPROPYL PROPIONAMIDEINACTIVE INGREDIENT6QOP5A9489DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHDERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TDERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]1
PPG-2 HYDROXYETHYL COCAMIDEINACTIVE INGREDIENT34N07GUJ3XDERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3DERMACINRX LEXITRAL PHARMAPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]1
ROSEMARY OILINACTIVE INGREDIENT8LGU7VM393DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKDERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]1
waterINACTIVE INGREDIENT059QF0KO0RDERMACINRX LEXITRAL PHARMAPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RDERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-310DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]6Current NDC, Legacy NDC, 2 package rows20241004_1e343a52-6071-3230-e054-00144ff8d46c.zip
59088-310INFLAMMACIN (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]5Current NDC, Legacy NDC20241206_91d25301-fac9-41f0-8a4e-e22d44926347.zip
59088-310LEXTOL (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]2Current NDC, Legacy NDC20241208_042765e5-bd75-8224-e063-6394a90a141b.zip
59088-310NAPROTIN (NAPROXEN , CAPSAICIN) KIT [PURETEK CORPORATION]2Current NDC, Legacy NDC20241215_dc2d2783-2a73-cb7c-e053-2995a90a9961.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 72 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Care Anti-ItchHYDROCORTISONEUnited Exchange Corp.8e4d46d8-7084-0666-e053-2995a90ad5202025-10-21WarningsExact identifier
application number: M017
Coralite Pain ReliefCAMPHOR, MENTHOL, METHYL SALICYLATEUnited Exchange Corp.69aec845-3d4c-d226-e053-2991aa0afd122025-10-21WarningsExact identifier
application number: M017
WHITE FLOWER ANALGESIC BALMCAMPHOR, MENTHOL AND METHYL SALICYLATEHOE HIN PAK FAH YEOW MANUFACTORY LTDf3e3b8b5-b12b-49ac-9318-b0c358b136e92025-10-21WarningsExact identifier
application number: M017
Mountain Ice Sports RecoveryMENTHOLMountainside Medical Equipment, Inc.98638529-3c17-436e-901f-c8aea52bdab62025-10-20WarningsExact identifier
application number: M017
Lip Clear Lysine PlusMENTHOL, UNSPECIFIED FORMQuantum, Inc.21a5b4fb-baed-4766-9820-5c6051c147202025-10-20WarningsExact identifier
application number: M017
Buzz Away Sting SootheMENTHOLQuantum, Inc.419e34ea-17b2-ec32-e063-6394a90a603d2025-10-20WarningsExact identifier
application number: M017
Family Care Anti-ItchHYDROCORTISONEUnited Exchange Corp.deb09e89-9794-89a7-e053-2a95a90abdf82025-10-20WarningsExact identifier
application number: M017
Numbing CreamMENTHOLFlexiGo Inc41571c8f-332b-f423-e063-6394a90a88972025-10-20WarningsExact identifier
application number: M017
Soothing Nerve TherapyMENTHOLWise Consumer Products40829d6b-5005-7ec9-e063-6294a90a970e2025-10-20WarningsExact identifier
application number: M017
Numbing CreamMENTHOLFlexiGo Inc4146fd51-b18c-393d-e063-6294a90a4d9a2025-10-20WarningsExact identifier
application number: M017
Lidocaine 4% Maximum OTC StrengthLIDOCAINECardinal Health 107, LLC975031df-d46d-4098-b1c0-1c0c92b419952025-10-20WarningsExact identifier
application number: M017
Cortizone 10 Intensive HealingHYDROCORTISONEChattem, Inc.bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c2025-10-20WarningsExact identifier
application number: M017
Sting relief padBENZOCAINE, ALCOHOLGuangdong Comfort Medical Products Co., Ltd.6e905065-10a9-1ded-e053-2a91aa0a46a12025-10-19WarningsExact identifier
application number: M017
CVS Cold and HotMENTHOLCVS Pharmacya44cec95-822a-40b6-e053-2995a90ae31c2025-10-17WarningsExact identifier
application number: M017
Sombra MaxSOMBRA MAXSombra Cosmetics Inc.41623a46-e6e7-907e-e063-6394a90afc4c2025-10-17WarningsExact identifier
application number: M017
POMADA DRAGON PAIN RELIEVINGCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATETELEVISA CONSUMER PRODUCTS USAc283291d-feaa-4f89-8fde-9e3957ea8b9f2025-10-17WarningsExact identifier
application number: M017
Ear Pain MDLIDOCAINE HYDROCHLORIDEEosera Inc78c4418f-7f0f-447f-a94f-d4c89a081af12025-10-17WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.414217c1-ff3a-b556-e063-6394a90aa5db2025-10-16WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.41422d04-160b-51b2-e063-6294a90ab2b22025-10-16WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.41427275-4c35-bbdf-e063-6294a90a14cf2025-10-16WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198555capsaicin 0.025 % Topical CreamPSN1e343a52-6071-3230-e054-00144ff8d46c6
198555capsaicin 0.25 MG/ML Topical CreamSCD1e343a52-6071-3230-e054-00144ff8d46c6
198555capsaicin 0.025 % Topical CreamSY1e343a52-6071-3230-e054-00144ff8d46c6
198555capsaicin 0.025 % Topical CreamPSN91d25301-fac9-41f0-8a4e-e22d449263475
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN91d25301-fac9-41f0-8a4e-e22d449263475
198555capsaicin 0.25 MG/ML Topical CreamSCD91d25301-fac9-41f0-8a4e-e22d449263475
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD91d25301-fac9-41f0-8a4e-e22d449263475
198555capsaicin 0.025 % Topical CreamSY91d25301-fac9-41f0-8a4e-e22d449263475
198555capsaicin 0.025 % Topical CreamPSN042765e5-bd75-8224-e063-6394a90a141b3
857700diclofenac sodium 1.5 % Topical SolutionPSN042765e5-bd75-8224-e063-6394a90a141b3
198555capsaicin 0.25 MG/ML Topical CreamSCD042765e5-bd75-8224-e063-6394a90a141b3
857700diclofenac sodium 15 MG/ML Topical SolutionSCD042765e5-bd75-8224-e063-6394a90a141b3
198555capsaicin 0.025 % Topical CreamSY042765e5-bd75-8224-e063-6394a90a141b3
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY042765e5-bd75-8224-e063-6394a90a141b3
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY042765e5-bd75-8224-e063-6394a90a141b3
198555capsaicin 0.025 % Topical CreamPSNdc2d2783-2a73-cb7c-e053-2995a90a99612
198014naproxen 500 MG Oral TabletPSNdc2d2783-2a73-cb7c-e053-2995a90a99612
198555capsaicin 0.25 MG/ML Topical CreamSCDdc2d2783-2a73-cb7c-e053-2995a90a99612
198014naproxen 500 MG Oral TabletSCDdc2d2783-2a73-cb7c-e053-2995a90a99612
198555capsaicin 0.025 % Topical CreamSYdc2d2783-2a73-cb7c-e053-2995a90a99612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-310-0859088031008118 mL in 1 BOTTLE, PUMP (59088-310-08) 118 ml2021-10-250000-00-00NoNoCurrent
59088-310-1659088031016237 mL in 1 BOTTLE, PUMP (59088-310-16) 237 ml2015-06-090000-00-00NoNoCurrent