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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct0536-2525EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0536-25250536-2525-25EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S07O44R1ZMInternal 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
c5915c84-84a2-46f6-9f97-0d9873e9944aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
7f54af34-be54-4c3c-894f-78df6452d747Product name320190703
ccf8541e-b7dc-e6ba-06c9-15bf143a7850Product name520190611
05700d9e-ea6f-4aab-b0ed-1488f1d85d7bProduct name120180904
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
2f9d4e5c-e179-490e-8c43-f19e1e0ca228Product name120160720
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-2525-25Capsaicin1 in 1 CARTONCREAM18
0536-2525-25Capsaicin60 g in 1 TUBECREAM608
0536-2525-25Flexipak1 in 1 CARTONCREAM0.025 g in 100g1
0536-2525-25Flexipak60 g in 1 TUBECREAM60 g0.025 g in 100g1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-2525-25GM - Gram0536-252568eb3219-f221-4b69-88f5-6cbd7f09bbc112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CapsaicinACTIVE INGREDIENTS07O44R1ZMRUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]2
CAPSAICINACTIVE INGREDIENTS07O44R1ZMINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
RANITIDINE HYDROCHLORIDEACTIVE INGREDIENTBK76465IHMINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
CapsaicinACTIVE MOIETYS07O44R1ZMRUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]2
CAPSAICINACTIVE MOIETYS07O44R1ZMINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
DICLOFENACACTIVE MOIETY144O8QL0L1INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
RANITIDINEACTIVE MOIETY884KT10YB7INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LRUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]2
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
Cetyl AcetateINACTIVE INGREDIENT4Q43814HXSRUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]2
CETYL ACETATEINACTIVE INGREDIENT4Q43814HXSINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TRUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
PPG-20 Methyl Glucose Ether DistearateINACTIVE INGREDIENT0057334FABRUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]2
PPG-20 METHYL GLUCOSE ETHER DISTEARATEINACTIVE INGREDIENT0057334FABINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]2
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHRUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
STEARETH-100INACTIVE INGREDIENT4OH5W9UM87INFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
Steareth-100INACTIVE INGREDIENT4OH5W9UM87RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APRUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YRUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
TrolamineINACTIVE INGREDIENT9O3K93S3TKRUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RRUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RINFLAMMATION REDUCTION PACK KIT [TMIG, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-2525RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES]6Current NDC, Legacy NDC, 2 package rows20240214_c5915c84-84a2-46f6-9f97-0d9873e9944a.zip
0536-2525FLEXIPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [STERLING-KNIGHT PHARMACEUTICALS, LLC]1Current NDC, Legacy NDC20180127_7c14a409-88c5-4b9d-80a4-f9f80c64ebbf.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 1 of 154 · 3,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Jakwork Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5911d9b0-1acb-3546-e063-6294a90adb3a2026-08-15WarningsExact identifier
application number: M017
RVDU WARMING PAIN RELIEFCAPSAICINQIRUI NETWORK (SHENZHEN) CO., LTD.58eb2a86-bf25-d4b5-e063-6394a90af8c42026-08-13WarningsExact identifier
application number: M017
JJ Care First Aid BurnBENZALKONIUM CHLORIDE, LIDOCAINE HCINantong Health & Beyond Hygienic Products Inc.c41621fb-c549-4394-a4cb-cb81ef8c98df2026-08-13WarningsExact identifier
application number: M017
JJ CareHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.c88fa151-f8a8-4de2-98c9-71319bf53e362026-08-13WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESafetec of America, Inc.da2b3b2c-11e0-401b-bbd2-d019271d1b3d2026-08-13WarningsExact identifier
application number: M017
CVS Pain Relief Roll-On Lidocaine with LavenderLIDOCAINE HYDROCHLORIDECVS Pharmacy4aa53176-2103-b47b-e063-6394a90ac7352026-08-12WarningsExact identifier
application number: M017
JUST CBD SOOTHINGMENTHOL, CAMPHORJust Brands LLC5384e80f-c242-76a1-e063-6294a90aba0b2026-08-12WarningsExact identifier
application number: M017
RELIBONEOintmentTOPICAL ANALGESICOINTMENTGuangdong Jiaoyu Biotechnology Co., Ltd58ddaaf6-18ec-8c5b-e063-6294a90a28282026-08-12WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINTrifecta Pharmaceuticals USA LLC58de3a29-2bec-6e44-e063-6394a90a9c1a2026-08-12WarningsExact identifier
application number: M017
Muscle Rub CreamMUSCLE RUBALLIED TRADE LINK LLC11d33e60-8c64-4316-a29a-d17e3e6e4a282026-08-11WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC58c2b35c-e1ed-7ea8-e063-6294a90a14942026-08-11WarningsExact identifier
application number: M017
Arctic Ice Pain Relieving GelMENTHOLONEST LIMITEDc63ef7a5-d649-4fba-9361-d37f1150e21d2026-08-11WarningsExact identifier
application number: M017
Gee GasonMALE GENITAL DESENSITIZERMon Gars Boutique Inc58c75e5c-b801-017f-e063-6394a90a1c752026-08-11WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINTrifecta Pharmaceuticals USA LLC58c84330-15bf-c397-e063-6394a90aba052026-08-11WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONETARGET Corporation4a140b9a-0e3c-4b50-b9c0-9e72616bb7d52026-08-11WarningsExact identifier
application number: M017
Medicated BODYMENTHOLCVS Pharmacy, Inc.a0f61498-69c8-4ce0-bbd7-3a807f192d362026-08-11WarningsExact identifier
application number: M017
Muscle MoveMENTHOLSaje Natural Wellness Inc.526d3305-4cf8-2fc5-e063-6394a90ad53b2026-08-10WarningsExact identifier
application number: M017
CVS Pain ReliefMENTHOLCVS Pharmacy4aa629f5-8b8f-cc67-e063-6394a90a019f2026-08-07WarningsExact identifier
application number: M017
Instant Cooling Itch ReliefHYDROCORTISONECVS Pharmacy46545d04-5958-d136-e063-6394a90a34622026-08-07WarningsExact identifier
application number: M017
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE, ZINC ACETATECVS Pharmacy46921bea-fcbe-94d6-e063-6394a90a726b2026-08-07WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198555capsaicin 0.025 % Topical CreamPSNc5915c84-84a2-46f6-9f97-0d9873e9944a8
198555capsaicin 0.25 MG/ML Topical CreamSCDc5915c84-84a2-46f6-9f97-0d9873e9944a8
198555capsaicin 0.025 % Topical CreamSYc5915c84-84a2-46f6-9f97-0d9873e9944a8
198555capsaicin 0.025 % Topical CreamPSN7c733a30-5002-49e7-a6bd-7737a1d2461e4
198555capsaicin 0.25 MG/ML Topical CreamSCD7c733a30-5002-49e7-a6bd-7737a1d2461e4
198555capsaicin 0.025 % Topical CreamSY7c733a30-5002-49e7-a6bd-7737a1d2461e4
198555capsaicin 0.025 % Topical CreamPSNfd90a67d-d60d-a849-e053-6394a90a2cc82
198555capsaicin 0.025 % Topical CreamPSN1dab5315-5027-57ad-e054-00144ff8d46c2
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN1dab5315-5027-57ad-e054-00144ff8d46c2
198555capsaicin 0.25 MG/ML Topical CreamSCD1dab5315-5027-57ad-e054-00144ff8d46c2
198555capsaicin 0.25 MG/ML Topical CreamSCDfd90a67d-d60d-a849-e053-6394a90a2cc82
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD1dab5315-5027-57ad-e054-00144ff8d46c2
198555capsaicin 0.025 % Topical CreamSY1dab5315-5027-57ad-e054-00144ff8d46c2
198555capsaicin 0.025 % Topical CreamSYfd90a67d-d60d-a849-e053-6394a90a2cc82
198555capsaicin 0.025 % Topical CreamPSN7d77048b-b0b2-9ef8-e053-2991aa0a6a8f1
198555capsaicin 0.025 % Topical CreamPSN7c14a409-88c5-4b9d-80a4-f9f80c64ebbf1
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN7c14a409-88c5-4b9d-80a4-f9f80c64ebbf1
198555capsaicin 0.25 MG/ML Topical CreamSCD7c14a409-88c5-4b9d-80a4-f9f80c64ebbf1
198555capsaicin 0.25 MG/ML Topical CreamSCD7d77048b-b0b2-9ef8-e053-2991aa0a6a8f1
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD7c14a409-88c5-4b9d-80a4-f9f80c64ebbf1
198555capsaicin 0.025 % Topical CreamSY7d77048b-b0b2-9ef8-e053-2991aa0a6a8f1
198555capsaicin 0.025 % Topical CreamSY7c14a409-88c5-4b9d-80a4-f9f80c64ebbf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-2525-25005362525251 TUBE in 1 CARTON (0536-2525-25) / 60 g in 1 TUBE1 tube2012-03-010000-00-00NoNoCurrent