FDA.reportPublic FDA data

Capzasin Quick Relief

Product NDC
41167-7516
11-digit product format
411677516
Labeler code
41167
Product ID
41167-7516_c59167cb-f484-44bd-82b0-766e3f46ed50
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin and Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Chattem, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-12-01
Substance
CAPSAICIN; MENTHOL
Active strength
.00025; .1 g/g; g/g
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
Capzasin Quick Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.00025 g/g
MENTHOL.1 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S07O44R1ZMInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855923Internal RxNorm lookup
1043539Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d6c313a3-8dc6-4231-95b6-ac9399e1c1beAvailable 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
41167-7516-0Capzasin Quick Relief42.5 g in 1 TUBE, WITH APPLICATORGEL42.57
41167-7516-0Capzasin Quick Relief1 in 1 CARTONGEL17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZMCAPZASIN QUICK RELIEF (CAPSAICIN AND MENTHOL) GEL [CHATTEM, INC.]2
MENTHOLACTIVE INGREDIENTL7T10EIP3ACAPZASIN QUICK RELIEF (CAPSAICIN AND MENTHOL) GEL [CHATTEM, INC.]2
CAPSAICINACTIVE MOIETYS07O44R1ZMCAPZASIN QUICK RELIEF (CAPSAICIN AND MENTHOL) GEL [CHATTEM, INC.]2
MENTHOLACTIVE MOIETYL7T10EIP3ACAPZASIN QUICK RELIEF (CAPSAICIN AND MENTHOL) GEL [CHATTEM, INC.]2
ALLANTOININACTIVE INGREDIENT344S277G0ZCAPZASIN QUICK RELIEF (CAPSAICIN AND MENTHOL) GEL [CHATTEM, INC.]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XCAPZASIN QUICK RELIEF (CAPSAICIN AND MENTHOL) GEL [CHATTEM, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCAPZASIN QUICK RELIEF (CAPSAICIN AND MENTHOL) GEL [CHATTEM, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCAPZASIN QUICK RELIEF (CAPSAICIN AND MENTHOL) GEL [CHATTEM, INC.]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCAPZASIN QUICK RELIEF (CAPSAICIN AND MENTHOL) GEL [CHATTEM, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CAPZASIN QUICK RELIEF (CAPSAICIN AND MENTHOL) GEL [CHATTEM, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCAPZASIN QUICK RELIEF (CAPSAICIN AND MENTHOL) GEL [CHATTEM, INC.]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKCAPZASIN QUICK RELIEF (CAPSAICIN AND MENTHOL) GEL [CHATTEM, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCAPZASIN QUICK RELIEF (CAPSAICIN AND MENTHOL) GEL [CHATTEM, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-7516CAPZASIN QUICK RELIEF (CAPSAICIN AND MENTHOL) GEL [CHATTEM, INC.]6Current NDC, Legacy NDC, 2 package rows20231026_d6c313a3-8dc6-4231-95b6-ac9399e1c1be.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 130 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidoReal PatchLIDOCAINE AND MENTHOLFORREAL PHARMACEUTICALS LLC19f1c037-b4b8-47b0-b0f9-036691c1d3072024-07-05WarningsExact identifier
application number: M017
Lip Medex Lip BalmPETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.988f97e8-a59f-4bc0-9d71-60607364a6862024-07-01WarningsExact identifier
application number: M017
Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALMMENTHOLL'Oreal USA Products Incd580982f-dda6-4b03-bf84-342b9f2c6d932024-06-29WarningsExact identifier
application number: M017
Lip Medex CherryPETROLATUM, CAMPHOR (SYNTHETIC), AND MENTHOL, UNSPECIFIED FORMBlistex Inc.fa8b3fb1-08e5-4876-9c4a-6aa8c9f23af82024-06-28WarningsExact identifier
application number: M017
10% Methyl Salicylate Pain Relief Patch10% METHYL SALICYLATEAkron Coating & Adhesives1be1f1ce-3238-a8ed-e063-6294a90a5aed2024-06-27Exact identifier
application number: M017
Genuine First Aid Alcohol Cleansing PadBENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.c39c4d80-9718-459f-8ae4-ada043bba5b72024-06-26WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll OnMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA1bd5cf69-9a08-5e2e-e063-6394a90a03cd2024-06-26WarningsExact identifier
application number: M017
Solarcaine Burn Pain Relief 4ozSOLARCAINE BURN PAIN RELIEF 4OZWellSpring Pharmaceutical Corporation2c0389db-ceb2-422b-9575-bdb8fe649a1e2024-06-26WarningsExact identifier
application number: M017
astoneaHYDROCORTISONEASTONEA LABS PRIVATE LIMITEDde09e859-c5fd-0cc5-e053-2a95a90a147e2024-06-25WarningsExact identifier
application number: M017
HealthWise Pain Relief Lidocaine PatchLIDOCAINE 4%Veridian Healthcare0190196d-5f78-042b-e063-6294a90a37142024-06-25WarningsExact identifier
application number: M017
Eagle Brand Medicated OilMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA1bc1bf83-91ee-ec9d-e063-6394a90a3daf2024-06-25WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll OnMENTHOL, METHYL SALICYLATEBorden Company (Private) Limited1bc2f688-d0c4-690e-e063-6294a90abc382024-06-25WarningsExact identifier
application number: M017
Eagle Brand Medicated OilMENTHOL, METHYL SALICYLATEBorden Company (Private) Limited1b9fdac0-9fb0-e669-e063-6394a90aece92024-06-24WarningsExact identifier
application number: M017
CapsaicinCAPSAICINAsclemed USA, Inc.97d506bd-3215-4e2e-9914-af1c174dd4ab2024-06-20WarningsExact identifier
application number: M017
ABREVA Rapid Pain ReliefGLYCERIN, LIDOCAINEHaleon US Holdings LLC65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d2024-06-20WarningsExact identifier
application number: M017
Frankie Avalons ZERO PAIN Roll-On Pain RelieverCAPSAICINWHY ENTERPRISES LLCe32acb5f-5bc3-4228-b037-6315d080f5562024-06-17WarningsExact identifier
application number: M017
PUREGEN LABS Pain Relief 4 LidocaineLIDOCAINEAdvanced Rx LLC9dff40d8-8d7e-4629-bea5-987f5e68477d2024-06-11WarningsExact identifier
application number: M017
SMOOTH GATOR Head-Ezz AnalgesicMENTHOLSmooth Gator LLC02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd2024-06-10WarningsExact identifier
application number: M017
FIRST AID BURNLIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDEEpic Medical Supply Corpbd1b1873-e900-45eb-96a0-28f782b5a7cd2024-06-04WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEChain Drug Marketing Association Inc.1c834ba0-86b6-8e61-e063-6394a90a192d2024-06-04WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855923capsaicin 0.025 % / menthol 10 % Topical GelPSNd6c313a3-8dc6-4231-95b6-ac9399e1c1be7
1043539CAPZASIN Quick Relief 0.025 % / 10 % Topical GelPSNd6c313a3-8dc6-4231-95b6-ac9399e1c1be7
1043539capsaicin 0.00025 MG/MG / menthol 0.1 MG/MG Topical Gel [Capzasin Quick Relief]SBDd6c313a3-8dc6-4231-95b6-ac9399e1c1be7
855923capsaicin 0.00025 MG/MG / menthol 0.1 MG/MG Topical GelSCDd6c313a3-8dc6-4231-95b6-ac9399e1c1be7
855923capsaicin 0.025 % / menthol 10 % Topical GelSYd6c313a3-8dc6-4231-95b6-ac9399e1c1be7
1043539Capzasin Quick Relief (capsaicin 0.025 % / menthol 10 % ) Topical GelSYd6c313a3-8dc6-4231-95b6-ac9399e1c1be7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41167-7516-0411677516001 TUBE, WITH APPLICATOR in 1 CARTON (41167-7516-0) / 42.5 g in 1 TUBE, WITH APPLICATOR2008-12-010000-00-00NoNoCurrent