FDA.reportPublic FDA data

Capsaicin 0.1 Percent

Product NDC
50488-1060
11-digit product format
504881060
Labeler code
50488
Product ID
50488-1060_4dd9a4a8-6316-41d9-b9cc-75b31e9a0fb7
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin
Dosage form
CREAM
Route
TOPICAL
Labeler
Alexso, Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-01
Substance
CAPSAICIN
Active strength
.1 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 0.1 Percent
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.1 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
646333Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0090ca38-6433-45c4-9453-edf2788c14c6Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50488-1060-6Capsaicin 0.1 Percent60 g in 1 BOTTLECREAM603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-1060-6GM - Gram50488-106038c057db-e25e-4398-91c3-c254eaaaf44612020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50488-1060CAPSAICIN 0.1 PERCENT (CAPSAICIN) CREAM [ALEXSO, INC]3Current NDC, Legacy NDC, 1 package rows20241208_0090ca38-6433-45c4-9453-edf2788c14c6.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 10 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gaayou NumbingDIBUCAINE HYDROCHLORIDE 0.5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4c290118-7880-2a98-e063-6294a90a4c032026-07-21WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pain Relieving Cold GelCAMPHOR, MENTHOLActive and Innovative572792bb-2819-36c3-e063-6394a90aa5042026-07-21WarningsExact identifier
application number: M017
SYLVIRENE NUMBINGLIDOCAINE 4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a36edc5-5a89-afb5-e063-6294a90a02dd2026-07-21WarningsExact identifier
application number: M017
REINREUDE PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAINLIDOCAINE 4% PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAINJiangxi Yudexi Pharmaceutical Co., LTD4a45c1cb-c5ab-d872-e063-6394a90aab5d2026-07-21WarningsExact identifier
application number: M017
SERYNTH Muscle ComfortARNICA MONTANA HPUS 7% MUSCLE COMFORTJiangxi Yudexi Pharmaceutical Co., LTD4a4c10cd-f0c4-8731-e063-6394a90a10a52026-07-21WarningsExact identifier
application number: M017
DERMFREE MEDICATED LIPCAMPHOR 2.0% MEDICATED LIPJiangxi Yudexi Pharmaceutical Co., LTD4a4d62fb-8dfa-404a-e063-6294a90a385d2026-07-21WarningsExact identifier
application number: M017
NATUHEAL RELIEF Cream FOR ECZEMAHYDROCORTISONE ACETATE 1% RELIEF CREAM FOR ECZEMAJiangxi Yudexi Pharmaceutical Co., LTD4c92fed1-a8b4-bda8-e063-6394a90a8a332026-07-20WarningsExact identifier
application number: M017
REDCOOL Arnica BruiseARNICA MONTANA HPUS 7% ARNICA BRUISEJiangxi Zhongletang Pharmaceuticals Co.,Ltd.49911392-e55e-1a6b-e063-6394a90a9af02026-07-20WarningsExact identifier
application number: M017
Vamy HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD499197aa-f872-3abf-e063-6294a90aeda22026-07-20WarningsExact identifier
application number: M017
Subleef NUMBINGLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a201a6b-adde-c0a8-e063-6394a90a82852026-07-20WarningsExact identifier
application number: M017
PUVIDA NUMBINGMENTHOL 5% (W/W) NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4de4e317-2f4f-e5d6-e063-6394a90a06112026-07-20WarningsExact identifier
application number: M017
Careland Lidocaine Plus Menthol Pain Relieving Gel PatchesLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.8b607c03-a98f-445a-a69e-7625a76ac44b2026-07-20WarningsExact identifier
application number: M017
Yodo SalilOINTMENTLaboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA.56812625-7eab-6a25-e063-6294a90a23fe2026-07-20WarningsExact identifier
application number: M017
VBBV NumbingLIDOCAINEJiashen International Trade Limited5716c36b-6e97-c294-e063-6394a90aaf5c2026-07-20WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINEPremier Brands of America Inc.560c29cc-2453-5d14-e063-6394a90a844f2026-07-17WarningsExact identifier
application number: M017
4% Lidocaine Pain Relief PatchLIDOCAINE 4%Guangxi Keyun E-commerce Co., Ltd.4981e9c3-2a19-aed8-e063-6294a90af2162026-07-17WarningsExact identifier
application number: M017
endurance wipeBENZOCAINEAbsorption Pharmaceuticals, LLC303db1de-94fc-4543-e063-6294a90a01b92026-07-17WarningsExact identifier
application number: M017
Professional Therapy MuscleCare pain relieving gel Extra StrengthCAMPHOR, MENTHOLActive and Innovative Inc.56d30c33-ef5a-c63d-e063-6294a90acd292026-07-17WarningsExact identifier
application number: M017
Mineral Ice Extreme Gel Alpine Fresh ScentMENTHOLCarlin Consumer Health LLC56d3ca3d-21e1-a40a-e063-6294a90a9ff42026-07-17WarningsExact identifier
application number: M017
DRAVYNOR TOPICAL ANALGESIC HEAT PatchMENTHOL 24MG CAPSAICIN 16MG TOPICAL ANALGESIC HEAT PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.56b83ee8-8d86-9436-e063-6294a90a0c252026-07-16WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
646333capsaicin 0.1 % Topical CreamPSN0090ca38-6433-45c4-9453-edf2788c14c63
646333capsaicin 1 MG/ML Topical CreamSCD0090ca38-6433-45c4-9453-edf2788c14c63
646333capsaicin 0.1 % Topical CreamSY0090ca38-6433-45c4-9453-edf2788c14c63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50488-1060-65048810600660 g in 1 BOTTLE (50488-1060-6) 60 g2020-02-010000-00-00NoNoCurrent