FDA.reportPublic FDA data

Capsaicin

Product NDC
79643-011
11-digit product format
796430011
Labeler code
79643
Product ID
79643-011_5d6e9f4f-308a-d666-e063-6294a90ac515
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin
Dosage form
CREAM
Route
TOPICAL
Labeler
PHARMACURE LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-05
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
Listing expiration
2027-12-31

Active Ingredients#

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

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
79643-011-01Capsaicin1 in 1 BOXCREAM11
79643-011-01Capsaicin100 g in 1 TUBECREAM1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79643-011-01GM - Gram79643-0113992615a-5205-405e-a7c4-d165dfd733c312025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79643-011CAPSAICIN CREAM [PHARMACURE LLC]1Current NDC, 2 package rows20250207_b2b2de93-d957-43d7-a2a8-b46bcaea1f0d.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 120 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alocane MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a35ac19-6883-a733-e063-6294a90ad22d2024-11-05WarningsExact identifier
application number: M017
Alocane PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products, Inc.cfe8114b-df65-064b-e053-2a95a90a33f62024-11-05WarningsExact identifier
application number: M017
Alocane BotanicalsLIDOCAINE HYDROCHLORIDEQuest Products, LLC.02a8e5c7-56f4-eb0d-e063-6294a90a80cd2024-11-05WarningsExact identifier
application number: M017
Alocane Emergency Burn PadsLIDOCAINE HYDROCHLORIDEQuest Products, Inc.fe58bb89-7216-4121-afd3-d1438bdfbfa22024-11-05WarningsExact identifier
application number: M017
Licefreee AfterLicePRAMOXINE HCITec Laboratories Inc.06c4cc42-a215-3949-e063-6394a90a665e2024-11-05WarningsExact identifier
application number: M017
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEASO LLCcb9505b7-222d-3a24-e053-2a95a90a0b642024-11-05WarningsExact identifier
application number: M017
TopCare Pain Relieving AnalgesicLIDOCAINE HYDROCHLORIDETopco Associates LLC6b4783e0-1987-4838-9e8c-b95426d62b282024-11-05WarningsExact identifier
application number: M017
Eagle Green BalmCAMPHOR MENTHOLBorden Company (Private) Limited6f7a796b-a31c-0e60-e053-2a91aa0a022b2024-11-04WarningsExact identifier
application number: M017
Muscular BalmCAPSAICIN MENTHOL METHYL SALICYLATEBorden Company (Private) Limiteded79f14e-6b3d-4bf2-9c34-d019c1ba25822024-11-04WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONEA-S Medication Solutions3e0aed2b-fee1-4a0c-a3d2-72cd2b3008e32024-11-04WarningsExact identifier
application number: M017
Walgreens Ice Blue Pain Relieving Topical AnalgesicMENTHOL, UNSPECIFIED FORMWalgreen Company1c0ee442-ffd2-4f6c-aab2-f70e295378ad2024-11-04WarningsExact identifier
application number: M017
Walgreen Cool n Heat Maximum Strength Pain RelievingMENTHOL, UNSPECIFIED FORMWalgreen Companyd5c79476-dde8-4a85-8878-bc2ac3a3d70b2024-11-04WarningsExact identifier
application number: M017
LIDOCAINELIDOCAINESTRATUS PHARMACEUTICALS INC87a4f559-a4f6-4b9f-98de-b55b073a11c62024-11-01WarningsExact identifier
application number: M017
Walgreens Nerve Pain Relieving Topical AnalgesicLIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORMWalgreen Company83849eca-e02f-4b43-b3a7-b25e987e08a82024-10-31WarningsExact identifier
application number: M017
Sanar Naturals Arnica WhiteCAMPHORSanvall Enterprises, Inc192039a2-aed6-821b-e063-6394a90a7f292024-10-31WarningsExact identifier
application number: M017
Sanar Naturals Arnica ReforzadaCAMPHORSanvall Enterprises, Inc1921a4b1-cd36-195e-e063-6294a90a87932024-10-31WarningsExact identifier
application number: M017
Sanar Naturals Arnica Pain Releiving Roll On with CamphorCAMPHORSanvall Enterprises, Inc173db0e2-611f-55b9-e063-6394a90ac9872024-10-31WarningsExact identifier
application number: M017
Sanar Naturals CamphorCAMPHORSanvall Enterprises, Inc1921e851-cf83-0bdb-e063-6294a90a357f2024-10-31WarningsExact identifier
application number: M017
cortisoneHYDROCORTISONECVS Pharmacyc766deac-d993-4e48-a5c3-4cfde7338dff2024-10-31WarningsExact identifier
application number: M017
Walgreens Pain Relieving with Lavender AnalgesicLIDOCAINE HYDROCHLORIDEWalgreen Company6c7b39c8-5b65-430a-a529-5b6b14adce182024-10-31WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577395capsaicin 0.035 % Topical CreamPSNb2b2de93-d957-43d7-a2a8-b46bcaea1f0d1
577395capsaicin 0.35 MG/ML Topical CreamSCDb2b2de93-d957-43d7-a2a8-b46bcaea1f0d1
577395capsaicin 0.035 % Topical CreamSYb2b2de93-d957-43d7-a2a8-b46bcaea1f0d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79643-011-01796430011011 TUBE in 1 BOX (79643-011-01) / 100 g in 1 TUBE1 tube2025-02-05NoNoCurrent