Capsaicin 0.035% cream

Product NDC
82461-417
11-digit product format
824610417
Labeler code
82461
Product ID
82461-417_0371fc78-d964-4a3c-a2c3-7a1f6e8ad18a
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin
Dosage form
CREAM
Route
TOPICAL
Labeler
Medcore LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-04
Substance
CAPSAICIN
Active strength
.35 mg/mL
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 0.035% cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.35 mg/mL

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
577395Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0236e1e4-c26c-4fff-a83b-143ce26d93bfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82461-417-10Capsaicin 0.035% cream100 mL in 1 BOTTLE, PUMPCREAM1001

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 81 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine 3%LIDOCAINE HCL 3%PureTek Corporation3bc94d52-fe52-9fd6-e063-6294a90a43402025-08-12WarningsExact identifier
application number: M017
Fast FreezeMENTHOLNatural Essentials Inc.d8c42c8d-6ce0-43bf-b165-41979f3d8f792025-08-12WarningsExact identifier
application number: M017
Careland X-large Lidocaine 4 Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.a6867506-4a46-47b1-b5b6-bfedb59dfde62025-08-11WarningsExact identifier
application number: M017
Dermedial Anti-OuchMENTHOLSaje Natural Business Inc.3c194b8f-cfa5-11e3-e063-6394a90a92de2025-08-11WarningsExact identifier
application number: M017
Thera Plus Extra Strength Muscle Rub Topical AnalgesicMENTHOLFOURSTAR GROUP USA, INC.8a3b6adf-afbb-4d77-a19b-a6514ebd3b502025-08-11WarningsExact identifier
application number: M017
EARTHS CARE ARTHRITISCAPSAICINDLC Laboratories, Inc.9460674b-057e-40b9-a0f9-ca3d92068d4f2025-08-11WarningsExact identifier
application number: M017
LILAS PERIODMENTHOLLilas Wellness, Inc.5ea53b4b-45e6-48a7-8090-09c3a21e7f632025-08-11WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel Roll-OnLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd31639407-0f11-bde2-e063-6294a90af6942025-08-10WarningsExact identifier
application number: M017
Chinese Red Tiger Lidocaine PatchesLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd20cd369c-3e98-3d8f-e063-6394a90a08242025-08-10WarningsExact identifier
application number: M017
Treatonic LIDOCAINE PAIN RELIEFLIDOCAINE 4%100 KARMA INC3bd66b03-ac82-2d45-e063-6294a90a610a2025-08-08WarningsExact identifier
application number: M017
Capsaicin 0.025%CAPSAICIN 0.025%Advanced Rx of Tennessee, LLC3bdcef94-d06f-9152-e063-6294a90a60722025-08-08WarningsExact identifier
application number: M017
MENTHOL 5%MENTHOL 5%Advanced Rx of Tennessee, LLC3bdd0c52-29d8-ab67-e063-6294a90a9c452025-08-08WarningsExact identifier
application number: M017
Methyl Salicylate 25% CreamMETHYL SALICYLATEAdvanced Rx of Tennessee, LLC3bdd3015-349a-0fac-e063-6394a90afe412025-08-08WarningsExact identifier
application number: M017
LIDOCAINE 4%LIDOCAINE 4%Advanced Rx of Tennessee, LLC3bdd6b3d-7180-288c-e063-6394a90a17852025-08-08WarningsExact identifier
application number: M017
Good Sense Pain Relief Roll OnLIDOCAINE HCLGeiss, Destin & Dunn, Inc38e76fd6-e5fb-493c-e063-6294a90afed42025-08-08WarningsExact identifier
application number: M017
Aruba Aloe AlcoholadaLIDOCAINE HYDROCHLORIDEAruba Aloe Balm NVf56c62b0-75db-4499-858e-54e10b0e140a2025-08-07WarningsExact identifier
application number: M017
SurviveX Hydrocortisone CreamHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.3bd1da8d-5142-798c-e063-6294a90a7be62025-08-07WarningsExact identifier
application number: M017
Arthcal SOOTHING PAIN RELIEF MASSAGESOOTHING PAIN RELIEF MASSAGEBeijing JUNGE Technology Co., Ltd.3524ad62-0ed6-f2e5-e063-6394a90a32832025-08-06WarningsExact identifier
application number: M017
Alumier MD Intensive RecoveryHYDROCORTISONEAlumier Labsd9b79ea1-6558-543c-e053-2995a90ae53e2025-08-06WarningsExact identifier
application number: M017
Good Neighbor Roll-on Pain ReliefLIDOCAINE HCLAmerisource Bergena0c3adbf-fa35-47c0-9db3-459ce9a106ac2025-08-06WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577395capsaicin 0.035 % Topical CreamPSN0236e1e4-c26c-4fff-a83b-143ce26d93bf1
577395capsaicin 0.35 MG/ML Topical CreamSCD0236e1e4-c26c-4fff-a83b-143ce26d93bf1
577395capsaicin 0.035 % Topical CreamSY0236e1e4-c26c-4fff-a83b-143ce26d93bf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82461-417-1082461041710100 mL in 1 BOTTLE, PUMP (82461-417-10) 100 ml2026-05-04NoNoCurrent