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 149 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocortisone AcetateHYDROCORTISONE ACETATEBentlin Products LLC4346351c-8e11-46ae-b428-98d17f55beb92023-10-30WarningsExact identifier
application number: M017
Biofreeze Roll-OnMENTHOLA-S Medication Solutions814b37ea-5441-4cec-8794-71ca01d849ae2023-10-30WarningsExact identifier
application number: M017
Dr. Sheffield Hydrocortisone Anti itchHYDROCORTISONESheffield Pharmaceuticals LLC71c9f2f4-2188-45eb-b55e-3856ac78070b2023-10-30WarningsExact identifier
application number: M017
Family WellnessBENZOCAINE, RESORCINOLZhejiang Jingwei Pharmaceutic Al Co., Ltd.df540eb8-6773-4647-9cc2-c3fd14d7355e2023-10-27WarningsExact identifier
application number: M017
Family WellnessHYDROCORTISONE 1%FRONT PHARMACEUTICAL PLCea26265d-f24e-458e-8bf0-287b2d49f4f42023-10-27WarningsExact identifier
application number: M017
Joint Formula 88 MAX PLUSCAMPHORSarati International, Inc.f5d78335-b78d-4909-a88b-9daa3c18ba152023-10-27WarningsExact identifier
application number: M017
OsmoFlexMENTHOLSarati International, Inc.479147c0-4cf4-4d7a-8b8e-1a0de49ed73e2023-10-27WarningsExact identifier
application number: M017
Thera plus Anti-itch with aloe HydrocortisoneHYDROCORTISONEFourstar Group USA, Inc.c69d0670-a65b-1680-e053-2995a90a2ee52023-10-26WarningsExact identifier
application number: M017
Family WellnessDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEFRONT PHARMACEUTICAL PLCfde2069b-344e-46da-bb95-c5113e0f35d62023-10-26WarningsExact identifier
application number: M017
MAXIMUM STRENGTH HEMORRHOIDAL RELIEFLIDOCAINECVS PHARMACY, INCb61424bf-3b23-420b-a7bc-256ddb96aa222023-10-25WarningsExact identifier
application number: M017
AssuredHYDROCORTISONEZhejiang Jingwei Pharmaceutic Al Co., Ltd.bc97f364-9443-47b8-9c2d-b5dcc00cc9b72023-10-25WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOL, UNSPECIFIED FORMTroy Manufacturing, Inc.b41091b4-0dc0-4a88-8ff6-11979b3d307a2023-10-25WarningsExact identifier
application number: M017
Thera PlusHYDROCORTISONEZhejiang Jingwei Pharmaceutical Co., Ltd.bcc99e5a-2403-46da-9c9d-8411fa4104e02023-10-25WarningsExact identifier
application number: M017
AssuredLIDOCAINE HYDROCHLORIDEZhejiang Jingwei Pharmaceutical Co., Ltd.ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c2023-10-25WarningsExact identifier
application number: M017
Red hotCAPSAICINThe Hygenic Company, LLCd100092c-e10b-2063-e053-2995a90aedb22023-10-25WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.c8d4ae28-efc4-6a00-e053-2a95a90a40bf2023-10-25WarningsExact identifier
application number: M017
Cryo10 Topical AnalgesicMENTHOLElement 26 LLCff1d2140-9302-918c-e053-6394a90acb9a2023-10-25WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.3336cc35-e773-4705-84b5-61040604beef2023-10-25WarningsExact identifier
application number: M017
CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin ProtectantBENZOCAINE, WHITE PETROLATUMCarma Laboratories, Inc.bbf0abcd-b7d6-b5e4-e053-2995a90a52402023-10-25WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.bbee66b9-39ff-4e7e-e053-2995a90a43be2023-10-25WarningsExact 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