FDA.reportPublic FDA data

Capsaicin

Product NDC
79643-007
11-digit product format
796430007
Labeler code
79643
Product ID
79643-007_5d6e8ccf-0193-5a70-e063-6394a90ab8c4
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
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
79643-007-01Capsaicin8 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 141 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEADER Camphor SpiritCAMPHOR (NATURAL)Cardinal Health, 110 dba Leader7d3b0b28-5190-0622-e053-2991aa0af5612023-12-22WarningsExact identifier
application number: M017
Antiseptic Instant Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Pharma Nobis, LLCe42f484d-a642-3489-e053-2a95a90a42542023-12-22WarningsExact identifier
application number: M017
Itch Relief GelITCH RELIEF GELPharma Nobis, LLCe42f484d-a641-3489-e053-2a95a90a42542023-12-22WarningsExact identifier
application number: M017
Witch HazelWITCH HAZELPharma Nobis, LLCe42f484d-a644-3489-e053-2a95a90a42542023-12-22WarningsExact identifier
application number: M017
Dermoplast Pain relievingBENZOCAINE, MENTHOLAdvantice Healthdad00c95-4e11-3eec-e053-2a95a90a7a182023-12-21WarningsExact identifier
application number: M017
equate Maximum Strength Pain Relieving 4% Lidocaine with Lavender Essential Oil Topical analgesicLIDOCAINE HYDROCHLORIDEWal-Mart Stores, Inc.bf954949-a7b7-44ba-8565-f1d5c0a6c0d12023-12-21WarningsExact identifier
application number: M017
Bactine Max BandageLIDOCAINEWellSpring Pharmaceutical Corporation465dc46e-6435-4569-9516-f648d0fe0f092023-12-21WarningsExact identifier
application number: M017
Valtrum IMMEDIATE ACTION TOPICAL ANALGESICCAMPHOR, MENTHOL, METHYL SALICYLATELABORATORIOS QUANTIUM LLCc4efa317-8dd1-49e1-b7ca-9df2147edd3e2023-12-21WarningsExact identifier
application number: M017
DDM Camphor SpiritCAMPHOR 10%Discount Drug Mart5d56cbe6-4e48-79eb-e053-2a91aa0a74d32023-12-20WarningsExact identifier
application number: M017
Quality Choice Camphor SpiritCAMPHOR 10%Chain Drug Market Association8d352a67-2024-43d0-b525-038d398949e62023-12-20WarningsExact identifier
application number: M017
Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Chain Drug Market Association2cd60df3-bfde-4747-ba4f-7121612f2e632023-12-20WarningsExact identifier
application number: M017
Poison Ivy WashPRAMOXINE HCLChain Drug Market Association873a546b-90ae-50cb-e053-2a91aa0adbfb2023-12-20WarningsExact identifier
application number: M017
Premier Value Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Pharmacy Value Alliance LLC9d63f8ed-fc50-0d84-e053-2a95a90a6e922023-12-20WarningsExact identifier
application number: M017
Ear DropsCARBAMIDE PEROXIDE 6.5%CVS Pharmacy8a872991-01af-5fd0-e053-2995a90ac7f42023-12-20WarningsExact identifier
application number: M017
CVS Cold and Hot Roll-OnCOOL AND HEAT PAIN RELIEFCVS Pharmacyb8cc578a-be6d-90c0-e053-2995a90a77422023-12-20WarningsExact identifier
application number: M017
Sunmark Camphor SpiritCAMPHOR 10%Strategic Sourcing Services LLC667b3a9f-4a5c-4ef0-adbd-cce9a5f94faa2023-12-19WarningsExact identifier
application number: M017
DDM Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Discount Drug Mart5d56c74f-604d-4fed-e053-2a91aa0a417c2023-12-19WarningsExact identifier
application number: M017
HEB Camphor PhenolCAMPHOR 10.8% AND PHENOL 4.7%H E B5d573883-001d-e5a4-e053-2991aa0a62032023-12-18WarningsExact identifier
application number: M017
Petrocort Antipruritic Lip 21HYDROCORTISONEClinical Formula LLC7d408e08-d777-4dfb-bb5e-b4fe5d6f4c7b2023-12-15WarningsExact identifier
application number: M017
DermaWound Wound Care Venous StasisBENZOCAINE HYDROCHLORIDEProgressive Doctors, LLC6221ba86-8b7f-48c8-8284-6950f9fc36b12023-12-15WarningsExact 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