FDA.reportPublic FDA data

Capsaicin 0.035 Percent

Product NDC
71073-313
11-digit product format
710730313
Labeler code
71073
Product ID
71073-313_5e65d3dc-df4f-5427-e063-6394a90ab970
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin
Dosage form
PATCH
Route
TOPICAL
Labeler
Beijing HKKY Medical Tech. Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-03
Substance
CAPSAICIN
Active strength
.035 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 0.035 Percent
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.035 g/100g

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
2702859Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2e6ecf0d-3084-4409-9c65-3796ed3c0a89Available on FDA.report

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 117 of 147 · 2,937 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief Gel-PatchLIDOCAINE, MENTHOLR & Y Group, LLCfe0478d8-2f06-cd56-e053-6294a90a58e52024-10-30WarningsExact identifier
application number: M017
JOINT-RITIS PAIN RELIEVING ROLL-ONMENTHOLLifeline Naturals of America, Inc.ec5d99c4-6bba-45d1-84e0-12fb7cb314952024-10-30WarningsExact identifier
application number: M017
Walgreens Pain Relieving AnalgesicCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATEWalgreen Company3215a676-104c-43c3-aa36-b30d5b67799a2024-10-30WarningsExact identifier
application number: M017
Ultra-Strength Pain Relief AnalgesicCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMTARGET CORPORATION159c5a84-bf68-41dd-a2d3-bc24020372442024-10-30WarningsExact identifier
application number: M017
DG Health Cold n Hot Pain Relieving Topical AnalgesicMENTHOL, UNSPECIFIED FORMDolgencorp Inc8fe13b85-ab74-42f8-a664-d3d2959921ac2024-10-30WarningsExact identifier
application number: M017
DEBACHERE Butt Balm After Care Antiseptic Pain ReliefBENZOCAINE, BENZALKONIUM CHLORIDEDE.BACHERE USA LLC8ba42864-69bf-455c-98d4-7f4ff94edceb2024-10-29WarningsExact identifier
application number: M017
Signature Care HydrocortisoneHYDROCORTISONESafewaybeefab66-b056-4bf1-b047-0780704ab87e2024-10-29WarningsExact identifier
application number: M017
Rael PAIN RELIEF ROLL-ON AnalgesicCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMRael, Inc.e6c49606-7c13-4dc6-a22d-ba54173ba7882024-10-28WarningsExact identifier
application number: M017
Monistat Care Instant Itch ReliefBENZOCAINEInsight Pharmaceuticals LLC4e9dc791-419f-4c79-aed4-760f8c17a5dd2024-10-25WarningsExact identifier
application number: M017
ZYLOTROL PAIN RELIEVINGLIDOCAINE HCL, MENTHOLAsclemed USA, Inc.1553351c-aee8-4c40-9548-35cce246bda92024-10-25WarningsExact identifier
application number: M017
OutgroBENZOCAINEMedtech Products Inc.d6be8a1d-aca7-42b1-86da-881d42ffe8d52024-10-25WarningsExact identifier
application number: M017
Monistat Complete Care Instant Itch ReliefHYDROCORTISONEInsight Pharmaceuticals LLCa0f40504-6183-4f32-8d17-6586b3f386a62024-10-25WarningsExact identifier
application number: M017
Boil EaseBENZOCAINEInsight Pharmaceuticals LLCbf108934-5e1a-4059-9dcf-008f52a83fab2024-10-25WarningsExact identifier
application number: M017
Dermarest Eczema MedicatedHYDROCORTISONEInsight Pharmaceuticals LLC0292ab62-5088-45fa-a056-70c2fcc19ef72024-10-25WarningsExact identifier
application number: M017
anti itchHYDROCORTISONEMeijer, Inc.2db7bcab-acb8-48ad-8cd1-842ff7765ed92024-10-23WarningsExact identifier
application number: M017
NATUREANCE MIRACLEMENTHOLEROS GLOBAL CORPec1a2a1f-a38d-9c59-e053-2a95a90ad2682024-10-23WarningsExact identifier
application number: M017
Profoot Plantar Relief StripsCAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATERooftop Consumer Health, Inc.65e142d8-da21-4c55-9faf-b387cb6c2c0e2024-10-23WarningsExact identifier
application number: M017
Profoot Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATERooftop Consumer Health, Inc.cc011b79-2761-40f7-8142-88f8e30a179a2024-10-23WarningsExact identifier
application number: M017
Profoot Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEProfoot, Inc.06f82bde-41a1-35f6-e063-6394a90a64372024-10-23WarningsExact identifier
application number: M017
Deep Cover Bug Bite ReliefBENZOCAINEMorrisons Outdoors, LLC25010dd6-fb48-8ee7-e063-6394a90aee6c2024-10-21WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71073-313-017107303130110 PATCH in 1 CARTON (71073-313-01) / 100 g in 1 PATCH10 patch2025-07-03NoNoCurrent