FDA.reportPublic FDA data

Capsaicin

Product NDC
79643-002
11-digit product format
796430002
Labeler code
79643
Product ID
79643-002_5d6ccb0a-8b91-6a86-e063-6294a90ab030
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin
Dosage form
PATCH
Route
TOPICAL
Labeler
PHARMACURE LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-02-02
Substance
CAPSAICIN
Active strength
.025 g/100g
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
Capsaicin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.025 g/100g

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-03-2005a09ee5-e7a4-4758-8b16-f60b945a7d82
2023-03-2005a09ee5-e7a4-4758-8b16-f60b945a7d82
2023-03-2005a09ee5-e7a4-4758-8b16-f60b945a7d82
2023-01-3005a09ee5-e7a4-4758-8b16-f60b945a7d82
2023-01-3005a09ee5-e7a4-4758-8b16-f60b945a7d82
2023-01-3005a09ee5-e7a4-4758-8b16-f60b945a7d82

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79643-002-01Capsaicin100 g in 1 PATCHPATCH1005
79643-002-01Capsaicin10 in 1 BOXPATCH105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79643-002-01EA - Each79643-0029cc62b9f-8597-493c-ae49-9c5caff85cf412021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79643-002CAPSAICIN PATCH [PHARMACURE LLC]4Current NDC, Legacy NDC, 2 package rows20241220_05a09ee5-e7a4-4758-8b16-f60b945a7d82.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 103 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Professional Therapy MuscleCare Pain RelievingMENTHOL, CAMPHORActive and Innovative Inc.42f1abeb-f6d7-01c3-e054-00144ff88e882025-01-23WarningsExact identifier
application number: M017
LIDOCAINELIDOCAINEPHARMACURE LLC53384c51-6da1-4fa4-8782-2606ca3d1c6f2025-01-22WarningsExact identifier
application number: M017
CapsaicinCAPSAICINPHARMACURE LLC829afe1b-6b2a-42a9-9626-8e39b0105e702025-01-22WarningsExact identifier
application number: M017
FORTHiQ Pain Relief Lidocaine PatchPAIN RELIEF LIDOCAINE PATCHHenan Enokon Medical Instrument Co., Ltd.2c593420-5788-3422-e063-6394a90a18902025-01-22WarningsExact identifier
application number: M017
RETALIEF LIDOCAINE 5LIDOCAINEReliable 1 Laboratories LLC2c262f3c-8cb2-4384-e063-6294a90a436d2025-01-20WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEBorden Company (Private) Limited1c3e5068-dd61-ebdb-e063-6294a90a97cc2025-01-20WarningsExact identifier
application number: M017
PROHEAL BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.bbc0a5d6-1de6-4ca3-9bb4-a45662b5eab12025-01-19WarningsExact identifier
application number: M017
HERSTAT PLUS Cold Sore TreatmentCAMPHOR, MENTHOLHerstat (USA) Inc.e20ea714-663d-c4ac-e053-2a95a90a5ecc2025-01-18WarningsExact identifier
application number: M017
Pain Relief MedicatedCAMPHOR MENTHOL METHYL SALICYTATERITE AID CORPORATION60895211-69f3-478b-a33f-1c2071f629502025-01-16WarningsExact identifier
application number: M017
Elgin Pain ReliefMENTHOLEco-Logics, Inc.70eda21e-e566-42f4-9a49-b0d3ad0006522025-01-16WarningsExact identifier
application number: M017
Curist Lidocaine Patch Maximum StrengthLIDOCAINELittle Pharma, Inc.e574c188-cc65-287d-e053-2995a90a59722025-01-16WarningsExact identifier
application number: M017
Equate Hydrocortisone TopicalHYDROCORTISONEWalMart1f64555d-f77e-4a83-b222-fdb3ed7d88532025-01-16WarningsExact identifier
application number: M017
Equate HydrocortisoneHYDROCORTISONEWalMartf5c32b4a-1159-4b7a-b8ac-256d53020dc22025-01-16WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd296fcc36-563f-19ca-e063-6394a90ab3ae2025-01-15WarningsExact identifier
application number: M017
K19 RELIEFMENTHOLK19 LLCe2e1ca96-1ae8-4c99-b8de-ce26754292f92025-01-15WarningsExact identifier
application number: M017
AnecreamLIDOCAINE 4%Focus Health Group2d7706e2-7363-4047-96cb-85b718277e8c2025-01-15WarningsExact identifier
application number: M017
BoroleumCAMPHOR, MENTHOL, WHITE PETROLATUMReliable 1 Laboratories846568af-0fdd-a80e-e053-2a91aa0a9c9e2025-01-15WarningsExact identifier
application number: M017
LidoPro Pain ReliefCAPSAICIN AND LIDOCAINEAdvanced Rx of Tennessee, LLC27d5997b-1cc2-41c2-e063-6394a90ac74a2025-01-15WarningsExact identifier
application number: M017
Pain Relief Patch 4% LidocaineLIDOCAINEReliable 1 Laboratories LLC2b624763-c310-63d9-e063-6394a90a19282025-01-15WarningsExact identifier
application number: M017
Cannarelief 1000mgMENTHOLCarolina Cannabis Creations LLC01e2ae1a-c969-6dd2-e063-6394a90a9d9e2025-01-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043399capsaicin 0.025 % Medicated PatchPSN05a09ee5-e7a4-4758-8b16-f60b945a7d825
1043399capsaicin 0.00025 MG/MG Medicated PatchSCD05a09ee5-e7a4-4758-8b16-f60b945a7d825
1043399capsaicin 0.025 % Medicated PatchSY05a09ee5-e7a4-4758-8b16-f60b945a7d825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79643-002-017964300020110 PATCH in 1 BOX (79643-002-01) / 100 g in 1 PATCH10 patch2021-02-020000-00-00NoNoCurrent