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
Ingredient	Strength
CAPSICUM OLEORESIN	.25 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
UW86K581WY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
1e343a52-6071-3230-e054-00144ff8d46c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
111d457e-3138-4512-b0ba-d0cd760c4055	Product name	3	20250225
fef6ad89-235f-4274-ba49-a8e53642473e	Product name	2	20250225
0426261e-1bb9-b78b-abd2-80da765a7e3e	Product name	2	20240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7	Product name	5	20240320
0ac2f11f-f58d-baf2-71a0-680993b48a61	Product name	2	20231211
855d63c3-b090-4636-8fc7-6d39ad23c44f	Product name	1	20230829
bb58f410-04be-65dd-9211-e89ead899698	Product name	6	20230323
87fed3e6-8fba-48ef-96b0-3a7fb54b96ff	Product name	3	20230306
0fcbc38a-8b29-3348-1cef-5222ea53484f	Product name	4	20220516
c4e1eedc-aca2-4551-8382-89144ed9d049	Product name	3	20220126
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
8d368a34-1453-43ea-828d-0dbcd72b8794	Product name	8	20210622
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8	Product name	1	20200623
d6bab9d2-edce-a213-4796-226ab15472c3	Product name	6	20200616
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
2487e6ef-d419-42fc-aaf8-7acc805d2370	Product name	2	20170718
e071c814-e5e7-e7ed-ec76-428765d9c66b	Product name	2	20151120
93148e06-b8d7-4e6c-853e-62f807d17fbb	Product name	1	20151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247e	Product name	1	20150316
6f4f4521-fd56-1ae6-888b-3b021bd75c7c	Product name	1	20140508
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59088-310-08	DermacinRx Penetral Cream	118 mL in 1 BOTTLE, PUMP	CREAM	118		6
59088-310-16	DermacinRx Penetral Cream	237 mL in 1 BOTTLE, PUMP	CREAM	237		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59088-310-08	ML - Milliliter	59088-310	62c92dad-6454-4352-970c-42700b8b5956	1	2021-11-09
59088-310-16	ML - Milliliter	59088-310	3b67732f-9da0-4073-8393-932730657a45	1	2020-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAPSICUM OLEORESIN	ACTIVE INGREDIENT	UW86K581WY	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	1
CAPSICUM OLEORESIN	ACTIVE INGREDIENT	UW86K581WY	DERMACINRX LEXITRAL PHARMAPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]	1
Diclofenac Sodium	ACTIVE INGREDIENT	QTG126297Q	DERMACINRX LEXITRAL PHARMAPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]	1
CAPSICUM OLEORESIN	ACTIVE MOIETY	UW86K581WY	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	1
CAPSICUM OLEORESIN	ACTIVE MOIETY	UW86K581WY	DERMACINRX LEXITRAL PHARMAPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]	1
Diclofenac	ACTIVE MOIETY	144O8QL0L1	DERMACINRX LEXITRAL PHARMAPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	1
alcohol	INACTIVE INGREDIENT	3K9958V90M	DERMACINRX LEXITRAL PHARMAPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	1
ARNICA MONTANA FLOWER	INACTIVE INGREDIENT	OZ0E5Y15PZ	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	1
CARBOMER INTERPOLYMER TYPE A (55000 CPS)	INACTIVE INGREDIENT	59TL3WG5CO	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	1
dimethyl sulfoxide	INACTIVE INGREDIENT	YOW8V9698H	DERMACINRX LEXITRAL PHARMAPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]	1
ETHYL MENTHANE CARBOXAMIDE	INACTIVE INGREDIENT	6S7S02945H	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	1
EUTERPE OLERACEA WHOLE	INACTIVE INGREDIENT	Y57H6218HP	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	1
FLAX SEED	INACTIVE INGREDIENT	4110YT348C	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	DERMACINRX LEXITRAL PHARMAPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]	1
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE	INACTIVE INGREDIENT	9CO8OUL4TH	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	1
LAURYL LAURATE	INACTIVE INGREDIENT	GPW77G0937	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	1
MENTHYL LACTATE, (-)-	INACTIVE INGREDIENT	2BF9E65L7I	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	1
METHYL DIISOPROPYL PROPIONAMIDE	INACTIVE INGREDIENT	6QOP5A9489	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	1
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	1
PPG-2 HYDROXYETHYL COCAMIDE	INACTIVE INGREDIENT	34N07GUJ3X	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	DERMACINRX LEXITRAL PHARMAPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]	1
ROSEMARY OIL	INACTIVE INGREDIENT	8LGU7VM393	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	1
water	INACTIVE INGREDIENT	059QF0KO0R	DERMACINRX LEXITRAL PHARMAPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59088-310	DERMACINRX PENETRAL CREAM (CAPSAICIN) CREAM [PURETEK CORPORATION]	6	Current NDC, Legacy NDC, 2 package rows	20241004_1e343a52-6071-3230-e054-00144ff8d46c.zip
59088-310	INFLAMMACIN (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]	5	Current NDC, Legacy NDC	20241206_91d25301-fac9-41f0-8a4e-e22d44926347.zip
59088-310	LEXTOL (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]	2	Current NDC, Legacy NDC	20241208_042765e5-bd75-8224-e063-6394a90a141b.zip
59088-310	NAPROTIN (NAPROXEN , CAPSAICIN) KIT [PURETEK CORPORATION]	2	Current NDC, Legacy NDC	20241215_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 111 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rite Aid Cooling Pain Relief	MENTHOL 10.5%	Rite Aid	e2225259-70ec-52de-e053-2a95a90a73f8	2024-12-15	Warnings	Exact identifier application number: M017
Rite Aid Rectal Care	LIDOCAINE 5%	Rite Aid	e283e462-96e8-04cf-e053-2a95a90a1d00	2024-12-15	Warnings	Exact identifier application number: M017
Rite Aid Anti-Itch	DIPHENHYDRAMINE HCL 2%	Rite Aid	e33898d8-1b8b-5c0b-e053-2995a90add08	2024-12-15	Warnings	Exact identifier application number: M017
Rite Aid Cala Itch Relief	PRAMOXINE HCL 1%, ZINC ACETATE 0.1%	Rite Aid	e29a9d59-4c7c-81aa-e053-2995a90a7056	2024-12-15	Warnings	Exact identifier application number: M017
CVS Roll-On	CAPSAISIN 0.1%	CVS	e8812c49-335e-61ea-e053-2995a90a17aa	2024-12-15	Warnings	Exact identifier application number: M017
Good Sense Burn Relief Aloe	LIDOCAINE HCL	Geiss, Destin & Dunn, Inc	b5a7f629-a88d-b49d-e053-2995a90a49fa	2024-12-15	Warnings	Exact identifier application number: M017
QC Burn Relief Aloe	LIDOCAINE HCL	Chain Drug Marketing Association Inc	b5e76f0c-0bfe-b13e-e053-2995a90a0861	2024-12-15	Warnings	Exact identifier application number: M017
Meijer Burn Relief	LIDOCAINE 0.5%	Meijer	bec60c93-5abd-ee04-e053-2a95a90acb61	2024-12-15	Warnings	Exact identifier application number: M017
QC Cool and Heat Roll-On	MENTHOL 16%	Chain Drug Marketing Association Inc	d35e9dfa-8a28-fdb3-e053-2995a90abc52	2024-12-15	Warnings	Exact identifier application number: M017
Meijer Cold and Hot Pain Relieving	MENTHOL 16%	Meijer	bec62df3-06c9-a115-e053-2995a90a4267	2024-12-15	Warnings	Exact identifier application number: M017
Tommie Copper Pain Relief	MENTHOL 16%	Tommie Copper, Inc.	b4dfa5fa-2d61-db1e-e053-2a95a90a7ac8	2024-12-15	Warnings	Exact identifier application number: M017
Pain Relief Liquid Roller	CAMPHOR 3.5%, MENTHOL 3.5%	Tommie Copper, Inc.	c9f0447e-de43-16a5-e053-2995a90a05c1	2024-12-15	Warnings	Exact identifier application number: M017
Tommie Copper Pain Relief Maximum Strength	TROLAMINE SALICYLATE 10%	Tommie Copper, Inc.	b622c14f-9bf3-0bbd-e053-2a95a90a2adc	2024-12-15	Warnings	Exact identifier application number: M017
Copperlife Pain Relief	TROLAMINE SALICYLATE 10%	Tommie Copper, Inc.	c94d00f9-42ce-1d43-e053-2a95a90a058d	2024-12-15	Warnings	Exact identifier application number: M017
Tommie Copper Pain Relief Roller	CAMPHOR 3.5%, MENTHOL 3.5%	Tommie Copper, Inc.	b6c3d6eb-b485-33b8-e053-2a95a90a41e1	2024-12-15	Warnings	Exact identifier application number: M017
Tommie Copper Pain Relief Roller	CAMPHOR 3.5%, MENTHOL 3.5%	Tommie Copper, Inc.	b4cd4fed-e8c8-db85-e053-2995a90a708b	2024-12-15	Warnings	Exact identifier application number: M017
Copperlife Pain Relief Liquid	MENTHOL 16%	Tommie Copper, Inc.	c93a0139-953b-5523-e053-2a95a90a0b2d	2024-12-15	Warnings	Exact identifier application number: M017
Tommie Copper Pain Relief	TROLAMINE SALICYLATE 10%	Tommie Copper, Inc.	ca011b03-a263-1908-e053-2995a90ad970	2024-12-15	Warnings	Exact identifier application number: M017
Warrior Chiggerex Relief	BENZOCAINE 10%	Derma Care Research Labs, LLC	dcf2f52b-2295-58e5-e053-2995a90a7fd8	2024-12-15	Warnings	Exact identifier application number: M017
Capsaicin Cream	CAPSAICIN	Trifecta Pharmaceuticals USA LLC	def8d341-06a7-0e9b-e053-2995a90a0ad6	2024-12-13	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UW86K581WY	CAPSICUM OLEORESIN	8023-77-6	CAPSICUM OLEORESIN
S07O44R1ZM	CAPSAICIN	404-86-4	Capsaicin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198555	capsaicin 0.025 % Topical Cream	PSN	1e343a52-6071-3230-e054-00144ff8d46c	6
198555	capsaicin 0.25 MG/ML Topical Cream	SCD	1e343a52-6071-3230-e054-00144ff8d46c	6
198555	capsaicin 0.025 % Topical Cream	SY	1e343a52-6071-3230-e054-00144ff8d46c	6
198555	capsaicin 0.025 % Topical Cream	PSN	91d25301-fac9-41f0-8a4e-e22d44926347	5
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	PSN	91d25301-fac9-41f0-8a4e-e22d44926347	5
198555	capsaicin 0.25 MG/ML Topical Cream	SCD	91d25301-fac9-41f0-8a4e-e22d44926347	5
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	SCD	91d25301-fac9-41f0-8a4e-e22d44926347	5
198555	capsaicin 0.025 % Topical Cream	SY	91d25301-fac9-41f0-8a4e-e22d44926347	5
198555	capsaicin 0.025 % Topical Cream	PSN	042765e5-bd75-8224-e063-6394a90a141b	3
857700	diclofenac sodium 1.5 % Topical Solution	PSN	042765e5-bd75-8224-e063-6394a90a141b	3
198555	capsaicin 0.25 MG/ML Topical Cream	SCD	042765e5-bd75-8224-e063-6394a90a141b	3
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	042765e5-bd75-8224-e063-6394a90a141b	3
198555	capsaicin 0.025 % Topical Cream	SY	042765e5-bd75-8224-e063-6394a90a141b	3
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	042765e5-bd75-8224-e063-6394a90a141b	3
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	042765e5-bd75-8224-e063-6394a90a141b	3
198555	capsaicin 0.025 % Topical Cream	PSN	dc2d2783-2a73-cb7c-e053-2995a90a9961	2
198014	naproxen 500 MG Oral Tablet	PSN	dc2d2783-2a73-cb7c-e053-2995a90a9961	2
198555	capsaicin 0.25 MG/ML Topical Cream	SCD	dc2d2783-2a73-cb7c-e053-2995a90a9961	2
198014	naproxen 500 MG Oral Tablet	SCD	dc2d2783-2a73-cb7c-e053-2995a90a9961	2
198555	capsaicin 0.025 % Topical Cream	SY	dc2d2783-2a73-cb7c-e053-2995a90a9961	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59088-310-08	59088031008	118 mL in 1 BOTTLE, PUMP (59088-310-08)	118 ml	2021-10-25	0000-00-00	No	No	Current
59088-310-16	59088031016	237 mL in 1 BOTTLE, PUMP (59088-310-16)	237 ml	2015-06-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lextol	PureTek Corporation	2025-12-19	HUMAN PRESCRIPTION DRUG LABEL	3
Naprotin	PureTek Corporation	2024-12-13	HUMAN PRESCRIPTION DRUG LABEL	2
Inflammacin™ (diclofenac sodium delayed release tablets, capsaicin cream) Rx Only	PureTek Corporation	2024-12-03	HUMAN PRESCRIPTION DRUG LABEL	5
DermacinRx Penetral Cream	PureTek Corporation	2024-10-02	HUMAN OTC DRUG LABEL	6
Lextol	PureTek Corporation	2023-08-23	HUMAN PRESCRIPTION DRUG LABEL	1
DermacinRx Lexitral PharmaPak	PureTek Corporation	2023-05-04	HUMAN PRESCRIPTION DRUG LABEL	9
DermacinRx Lexitral PharmaPak II	PureTek Corporation	2023-04-14	HUMAN PRESCRIPTION DRUG LABEL	2