Capsaicin

Product NDC: 0536-2525
11-digit product format: 005362525
Labeler code: 0536
Product ID: 0536-2525_a8b02e2a-9971-482b-97f4-82f344bd79db
Type: HUMAN OTC DRUG
Nonproprietary name: Capsaicin
Dosage form: CREAM
Route: TOPICAL
Labeler: Rugby Laboratories
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-03-01
Substance: CAPSAICIN
Active strength: .25 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Capsaicin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CAPSAICIN	.25 mg/g

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	S07O44R1ZM
Rxcui	198555

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
111d457e-3138-4512-b0ba-d0cd760c4055	Product name	3	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
bb58f410-04be-65dd-9211-e89ead899698	Product name	6	20230323
0fcbc38a-8b29-3348-1cef-5222ea53484f	Product name	4	20220516
c4e1eedc-aca2-4551-8382-89144ed9d049	Product name	3	20220126
8d368a34-1453-43ea-828d-0dbcd72b8794	Product name	8	20210622
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201
d6bab9d2-edce-a213-4796-226ab15472c3	Product name	6	20200616
7f54af34-be54-4c3c-894f-78df6452d747	Product name	3	20190703
ccf8541e-b7dc-e6ba-06c9-15bf143a7850	Product name	5	20190611
05700d9e-ea6f-4aab-b0ed-1488f1d85d7b	Product name	1	20180904
2487e6ef-d419-42fc-aaf8-7acc805d2370	Product name	2	20170718
2f9d4e5c-e179-490e-8c43-f19e1e0ca228	Product name	1	20160720
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0536-2525-25	2022-02-01	C162847	48780-1	d6a99b39-e84d-a426-e053-dadaa90af4c2	Rugby ® Capsaicin Cream External Analgesic
0536-2525-25	2022-02-01	C162847	48780-1	d6a99b39-e84d-a426-e053-dadaa90af4c2	Rugby ® Capsaicin Cream External Analgesic
0536-2525-25	2022-01-28	C162847	48780-1	d6a99b39-e84d-a426-e053-dadaa90af4c2	Rugby ® Capsaicin Cream External Analgesic
0536-2525-25	2022-01-28	C162847	48780-1	d6a99b39-e84d-a426-e053-dadaa90af4c2	Rugby ® Capsaicin Cream External Analgesic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0536-2525-25	Capsaicin	1 in 1 CARTON	CREAM	1		8
0536-2525-25	Capsaicin	60 g in 1 TUBE	CREAM	60		8
0536-2525-25	Flexipak	1 in 1 CARTON	CREAM		0.025 g in 100g	1
0536-2525-25	Flexipak	60 g in 1 TUBE	CREAM	60 g	0.025 g in 100g	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-2525-25	GM - Gram	0536-2525	68eb3219-f221-4b69-88f5-6cbd7f09bbc1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Capsaicin	ACTIVE INGREDIENT	S07O44R1ZM	RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]	2
CAPSAICIN	ACTIVE INGREDIENT	S07O44R1ZM	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
RANITIDINE HYDROCHLORIDE	ACTIVE INGREDIENT	BK76465IHM	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
Capsaicin	ACTIVE MOIETY	S07O44R1ZM	RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]	2
CAPSAICIN	ACTIVE MOIETY	S07O44R1ZM	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
RANITIDINE	ACTIVE MOIETY	884KT10YB7	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]	2
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
Cetyl Acetate	INACTIVE INGREDIENT	4Q43814HXS	RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]	2
CETYL ACETATE	INACTIVE INGREDIENT	4Q43814HXS	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
PEPPERMINT	INACTIVE INGREDIENT	V95R5KMY2B	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
PPG-20 Methyl Glucose Ether Distearate	INACTIVE INGREDIENT	0057334FAB	RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]	2
PPG-20 METHYL GLUCOSE ETHER DISTEARATE	INACTIVE INGREDIENT	0057334FAB	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]	2
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
STEARETH-100	INACTIVE INGREDIENT	4OH5W9UM87	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
Steareth-100	INACTIVE INGREDIENT	4OH5W9UM87	RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]	2
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
Stearyl Alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
Trolamine	INACTIVE INGREDIENT	9O3K93S3TK	RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0536-2525	RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES]	6	Current NDC, Legacy NDC, 2 package rows	20240214_c5915c84-84a2-46f6-9f97-0d9873e9944a.zip
0536-2525	FLEXIPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [STERLING-KNIGHT PHARMACEUTICALS, LLC]	1	Current NDC, Legacy NDC	20180127_7c14a409-88c5-4b9d-80a4-f9f80c64ebbf.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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	c5915c84-84a2-46f6-9f97-0d9873e9944a	8
198555	capsaicin 0.25 MG/ML Topical Cream	SCD	c5915c84-84a2-46f6-9f97-0d9873e9944a	8
198555	capsaicin 0.025 % Topical Cream	SY	c5915c84-84a2-46f6-9f97-0d9873e9944a	8
198555	capsaicin 0.025 % Topical Cream	PSN	7c733a30-5002-49e7-a6bd-7737a1d2461e	4
198555	capsaicin 0.25 MG/ML Topical Cream	SCD	7c733a30-5002-49e7-a6bd-7737a1d2461e	4
198555	capsaicin 0.025 % Topical Cream	SY	7c733a30-5002-49e7-a6bd-7737a1d2461e	4
198555	capsaicin 0.025 % Topical Cream	PSN	fd90a67d-d60d-a849-e053-6394a90a2cc8	2
198555	capsaicin 0.025 % Topical Cream	PSN	1dab5315-5027-57ad-e054-00144ff8d46c	2
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	PSN	1dab5315-5027-57ad-e054-00144ff8d46c	2
198555	capsaicin 0.25 MG/ML Topical Cream	SCD	1dab5315-5027-57ad-e054-00144ff8d46c	2
198555	capsaicin 0.25 MG/ML Topical Cream	SCD	fd90a67d-d60d-a849-e053-6394a90a2cc8	2
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	SCD	1dab5315-5027-57ad-e054-00144ff8d46c	2
198555	capsaicin 0.025 % Topical Cream	SY	1dab5315-5027-57ad-e054-00144ff8d46c	2
198555	capsaicin 0.025 % Topical Cream	SY	fd90a67d-d60d-a849-e053-6394a90a2cc8	2
198555	capsaicin 0.025 % Topical Cream	PSN	7d77048b-b0b2-9ef8-e053-2991aa0a6a8f	1
198555	capsaicin 0.025 % Topical Cream	PSN	7c14a409-88c5-4b9d-80a4-f9f80c64ebbf	1
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	PSN	7c14a409-88c5-4b9d-80a4-f9f80c64ebbf	1
198555	capsaicin 0.25 MG/ML Topical Cream	SCD	7c14a409-88c5-4b9d-80a4-f9f80c64ebbf	1
198555	capsaicin 0.25 MG/ML Topical Cream	SCD	7d77048b-b0b2-9ef8-e053-2991aa0a6a8f	1
855926	diclofenac sodium 75 MG Delayed Release Oral Tablet	SCD	7c14a409-88c5-4b9d-80a4-f9f80c64ebbf	1
198555	capsaicin 0.025 % Topical Cream	SY	7d77048b-b0b2-9ef8-e053-2991aa0a6a8f	1
198555	capsaicin 0.025 % Topical Cream	SY	7c14a409-88c5-4b9d-80a4-f9f80c64ebbf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0536-2525-25	00536252525	1 TUBE in 1 CARTON (0536-2525-25) / 60 g in 1 TUBE	1 tube	2012-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rugby ® Capsaicin Cream External Analgesic	NuCare Pharmaceuticals,Inc.	2025-02-04	HUMAN OTC DRUG LABEL	2
Rugby ® Capsaicin Cream External Analgesic	Rugby Laboratories \| Garcoa, Inc. \| SV Labs Toronto Corporation	2024-02-12	HUMAN OTC DRUG LABEL	8
Capsaicin Cream External Analgesic	Proficient Rx LP	2024-02-01	HUMAN OTC DRUG LABEL	4
Rugby ® Capsaicin Cream External Analgesic	medsource pharmaceuticals \| Garcoa, Inc.	2018-12-20	HUMAN OTC DRUG LABEL	1
FLEXIPAK - diclofenac sodium, capsaicin	Sterling-Knight Pharmaceuticals, LLC	2018-01-22	HUMAN PRESCRIPTION DRUG LABEL	1
Inflamation Reduction Pack	TMIG, Inc. \| EPM Packaging \| Garcoa, Inc. \| Sandoz Inc. \| Actavis Elizabeth LLC	2015-08-18	HUMAN PRESCRIPTION DRUG LABEL	2

Capsaicin

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#