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 85 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Veneno de Abeja Aceite De Vibora BrandMETHYL SALICYLATEMenper Distributors Inc.ad940dc8-9403-44cf-aed3-6e538cbe488b2025-07-22WarningsExact identifier
application number: M017
Balsamo de Vaca MascuraMETHYL SALICYLATEMenper Distributors Inc.321b6f1f-c802-4b96-99d3-e77217da11a32025-07-22WarningsExact identifier
application number: M017
Abejas y Viboras Roll OnMETHYL SALICYLATEMenper Distributors Inc.bedf3b36-7def-099f-e053-2a95a90ac15b2025-07-22WarningsExact identifier
application number: M017
HealthWise Flexible 4% Lidocaine PatchLIDOCAINE 4%Veridian Healthcare3869cc18-5494-6142-e063-6394a90a75e52025-07-22WarningsExact identifier
application number: M017
Arthcal 4% Lidocaine PatchesLIDOCAINEBeijing JUNGE Technology Co., Ltd.2e531194-67ad-c645-e063-6394a90a916c2025-07-22WarningsExact identifier
application number: M017
AMRUTANJAN RELIEF STRONG PAIN BALMMENTHOL, METHYL SALICYLATEAMRUTANJAN HEALTH CARE LIMITED206d8c1e-eb5b-4ec7-a54e-8defc9fb9d272025-07-22WarningsExact identifier
application number: M017
Cold Sore Fast-Acting Pain ReliefGLYCERIN AND LIDOCAINEBlistex Inc.c7511322-dd6c-441c-bf7d-ad4f0c14956a2025-07-22WarningsExact identifier
application number: M017
Mountain Ice Sports Pain ReliefMENTHOL, CAMPHORMountainside Medical Equipment, Inc.c1f5512c-67b1-4ff0-b1a5-616e883d436f2025-07-21WarningsExact identifier
application number: M017
Stopain Clinical Roll-OnMENTHOL, UNSPECIFIED FORMTroy Manufacturing, Inc.27703209-fdac-4620-a445-d89a84bc853d2025-07-21WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESTRATEGIC SOURCING SERVICES LLC9bac1869-8072-49bd-8568-a87a184d22002025-07-21WarningsExact identifier
application number: M017
Dr Kevin Khalili Pain Relief CreamMENTHOLDR. KHALILI LLC3a79b38c-9adc-60dd-e063-6394a90a5b302025-07-21WarningsExact identifier
application number: M017
ARTHRITIS PAIN RELIEFCAMPHOR, CAPSAICIN, METHYL SALICYLATEYUNNAN BAIYAO GROUP CO., LTD.671c57f0-3c6f-4416-bc81-f6930fef327b2025-07-21WarningsExact identifier
application number: M017
GoodSense Cooling Pain ReliefMENTHOLGeiss, Destin & Dunn, Inc2e5e1375-df07-9a43-e063-6394a90a99382025-07-20WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch CoolingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLCa7eae5dc-9db6-4bdf-9179-76060e75e0442025-07-18WarningsExact identifier
application number: M017
Nicotine PatchesNICOTINE PATCHESShenzhen TeLaFaErJiaLuo Technology Co., Ltd.3a1abd26-c0aa-8a65-e063-6294a90ab66e2025-07-17WarningsExact identifier
application number: M017
Aouiv 4% Lidocaine Numbing Cream4% LIDOCAINE NUMBING CREAMGuangzhou Qiexiran Cosmetics Co., Ltd.3a221dd2-e945-bd0e-e063-6294a90a8fb92025-07-17WarningsExact identifier
application number: M017
Alocane PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products, Inc.24538037-1d74-48a0-b909-98ecc57651fe2025-07-17WarningsExact identifier
application number: M017
Hydrocortisone anti-itch plusHYDROCORTISONEWal-Mart Stores, Inc.a0c6e180-b385-4a9b-a9cf-84a551f533d02025-07-16WarningsExact identifier
application number: M017
OTC Rescue Lidocaine Pain Relief PatchLIDOCAINEVeridian Healthcare0e742fc6-5f76-d202-e063-6394a90acf312025-07-16WarningsExact identifier
application number: M017
Itch ReliefHYDROCORTISONESTRATEGIC SOURCING SERVICES LLCae4b7cd6-8b5d-4d25-86f9-72260638bb942025-07-16WarningsExact 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