FDA.reportPublic FDA data

Capsaicin

Product NDC
79643-007
11-digit product format
796430007
Labeler code
79643
Product ID
79643-007_2c50564a-1ef8-c9aa-e063-6294a90a5553
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin
Dosage form
PATCH
Route
TOPICAL
Labeler
PHARMACURE LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-24
Substance
CAPSAICIN
Active strength
.035 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-12-31

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
829afe1b-6b2a-42a9-9626-8e39b0105e70Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79643-007-01Capsaicin8 g in 1 PATCHPATCH81
79643-007-01Capsaicin10 in 1 BOXPATCH101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79643-007-01EA - Each79643-007161763ae-5c1c-4d16-b677-a017d962f6e912025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79643-007CAPSAICIN PATCH [PHARMACURE LLC]1Current NDC, 2 package rows20250124_829afe1b-6b2a-42a9-9626-8e39b0105e70.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 55 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Magsoothium BodyMENTHOL, CAPSAICINUbu/Elements, Inc.f604d30c-b17c-ec01-e053-2a95a90aa3042025-12-15WarningsExact identifier
application number: M017
Salonpas pain relieving JETMENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.dd1ea3bf-891a-402e-8f43-14302bc9c3e52025-12-15WarningsExact identifier
application number: M017
Herbal Tendon Bone ReliefCAMPHOR MINTGuchutang Biotechnology (Longyan) Co., Ltd.45cf4040-9751-d24b-e063-6294a90aff272025-12-13WarningsExact identifier
application number: M017
ElixirLidoFastLIDOCAINE 5% CREAMELIXIR HEALTHCARE USA, LLC.45de5a3d-06c2-aa02-e063-6294a90a63d32025-12-13WarningsExact identifier
application number: M017
MEDI FIRST PLUSHYDROCORTISONE ACETATEOrazen Inc5781124a-60f4-4a64-80b7-ce5f28d495b52025-12-12WarningsExact identifier
application number: M017
MEDI-FIRSTHYDROCORTISONE ACETATEOrazen Incaeffd85c-58a7-4d64-bf94-977b6fbbe7132025-12-12WarningsExact identifier
application number: M017
Joint and Muscle ReliefMENTHOLSmart Cookie Solutions Inc.45c24d56-4dc9-2884-e063-6294a90a52cc2025-12-12WarningsExact identifier
application number: M017
PopstarDELAY SPRAYPineapple Brands LLC293b2da9-1261-0358-e063-6394a90aa08c2025-12-12WarningsExact identifier
application number: M017
Careland Pain Relief PlusCAMPHOR, MENTHOL, METHYL SALICYLATEPlanet (Anhui) Pharmaceutical Co., Ltd.d9e63ddd-d003-45fa-b156-7f4452c28cbd2025-12-12WarningsExact identifier
application number: M017
Glucosamine Cream EXTRA STRENGTHHISTAMINE DIHYDROCHLORIDEIDEAZ, LLCf4d414b7-89e7-ad65-e053-2a95a90a25d42025-12-12WarningsExact identifier
application number: M017
ARTHRITISMENTHOLSmith Amish, LLC20c36972-b695-1241-e063-6394a90adf632025-12-12WarningsExact identifier
application number: M017
FOOTMENTHOLSmith Amish, LLC20c48537-f55f-c10f-e063-6394a90a4cca2025-12-12WarningsExact identifier
application number: M017
Joint EaseMENTHOLSmith Amish, LLC20c4a0f8-bdc6-d89a-e063-6294a90aa8d82025-12-12WarningsExact identifier
application number: M017
Toast Screamin HotCAPSAICINIDEAZ, LLC331207e6-b8ac-b169-e063-6394a90ac1692025-12-12WarningsExact identifier
application number: M017
Pain Relief Gel-PatchLIDOCAINEKORVIA GLOBAL Inc.45ccfcae-a307-1c5f-e063-6294a90acf892025-12-12WarningsExact identifier
application number: M017
Lidospot patchLIDOCAINE AND MENTHOLFabrication Enterprises Inc3a6e94c4-1ca6-e77a-e063-6394a90a4bfc2025-12-12WarningsExact identifier
application number: M017
LETEBEE LIGHT neuropathy pain relief cream for feetMENTHOLGuangdong Aimu Biological Technology Co., Ltd45a99afc-15ec-76c2-e063-6294a90a22202025-12-11WarningsExact identifier
application number: M017
CintheraLIDOCAINEStrand Health Group2746e5b2-be2d-f2d2-e063-6394a90a36902025-12-11WarningsExact identifier
application number: M017
Equate Cool and Heat Pain Relieving LiquidCOOL AND HEAT PAIN RELIEFWalmart, Inc.ad156685-3bd5-6837-e053-2995a90ac7882025-12-11WarningsExact identifier
application number: M017
HUMCO Camphor SpiritCAMPHOR 10%Humco Holding Group, Inc.9a0ef0a3-3c79-41b2-8193-424a3ef9886f2025-12-11WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2702859capsaicin 0.035 % Medicated PatchPSN829afe1b-6b2a-42a9-9626-8e39b0105e701
2702859capsaicin 0.00035 MG/MG Medicated PatchSCD829afe1b-6b2a-42a9-9626-8e39b0105e701
2702859capsaicin 0.035 % Medicated PatchSY829afe1b-6b2a-42a9-9626-8e39b0105e701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79643-007-017964300070110 PATCH in 1 BOX (79643-007-01) / 8 g in 1 PATCH10 patch2025-01-24NoNoCurrent