FDA.reportPublic FDA data

Icy Hot Advanced Relief

Product NDC
41167-0801
11-digit product format
411670801
Labeler code
41167
Product ID
41167-0801_990c7f7a-f472-4b03-8b80-db04a6056da4
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor and Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
Chattem, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-12-01
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
.11; .16 g/g; g/g
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
Icy Hot Advanced Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC).11 g/g
MENTHOL.16 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1373219Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9979ff36-415b-44e4-bb10-6bf682cd00f9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0801-0Icy Hot Advanced Relief56 g in 1 TUBECREAM567
41167-0801-0Icy Hot Advanced Relief1 in 1 CARTONCREAM17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-0801-0GM - Gram41167-0801ca1740e5-75cd-4658-9c80-3e1767b9507f12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3AICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
4-TERT-BUTYLCYCLOHEXANOLINACTIVE INGREDIENTK0H1405S9CICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
ALLANTOININACTIVE INGREDIENT344S277G0ZICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5COICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
DIETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTA1A1I8X02BICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
DIISOPROPYL ADIPATEINACTIVE INGREDIENTP7E6YFV72XICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4ICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7IICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
PEG-150 STEARATEINACTIVE INGREDIENT7BSG7DF10QICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
PROPANEDIOLINACTIVE INGREDIENT5965N8W85TICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
SOY STEROLINACTIVE INGREDIENTPL360EPO9JICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
STEARETH-21INACTIVE INGREDIENT53J3F32P58ICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0801ICY HOT ADVANCED RELIEF (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]7Current NDC, Legacy NDC, 2 package rows20250327_9979ff36-415b-44e4-bb10-6bf682cd00f9.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 97 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AUVON Lidocaine Menthol Pain Relief PatchLIDOCAINE AND MENTHOLSHENZHEN YUWEN E-COMMERCE CO., LTD.300cf469-5ca2-a40d-e063-6294a90a68012025-03-20WarningsExact identifier
application number: M017
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.3a3af6e1-0281-462e-85e7-144cc5d46f322025-03-19WarningsExact identifier
application number: M017
Lidocaine 4%LIDOCAINEInnovida Pharmaeutique Corporationeb83a3dd-557e-4334-b806-5fc05e9175a32025-03-19WarningsExact identifier
application number: M017
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.c04059e9-8175-46c2-8582-f84ef193abd32025-03-19WarningsExact identifier
application number: M017
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.3a36a241-37a9-445a-a6e0-97709a7457a82025-03-19WarningsExact identifier
application number: M017
Herb AnalgesicHERB ANALGESIC PASTEChangsha Maocheng Trading Co., Ltd29373587-9eff-6ea0-e063-6394a90a23b22025-03-18WarningsExact identifier
application number: M017
DEBACHERE Butt Balm After Play Care Multi Symptoms ReliefBENZOCAINE, BENZALKONIUM CHLORIDEDE.BACHERE USA LLCf469b446-58a0-4be3-884f-d622b9d074f82025-03-17WarningsExact identifier
application number: M017
Auvon 4% Menthol Pain Relief GelMENTHOLSHENZHEN YUWEN E-COMMERCE CO., LTD.2dacd6fe-7d69-bcf0-e063-6294a90a03512025-03-14WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEBorden Company (Private) Limited1ee49cad-84d4-42cf-aa83-c0da6f1b1b842025-03-14WarningsExact identifier
application number: M017
AY BENDITO THERMOACTIVEMENTHOL, CAMPHORAY BENDITO INTERNATIONAL, INC304d71b6-91c8-b2b6-e063-6394a90ab6692025-03-14WarningsExact identifier
application number: M017
Hot/Cold Medicated PatchHOT COLD PATCHDynarex999881b3-287e-d975-e053-2995a90a87e32025-03-14WarningsExact identifier
application number: M017
Capsaicin 0.025%CAPSAICIN 0.025%Marcella Health3054e7fd-cab2-7f77-e063-6294a90a498d2025-03-14WarningsExact identifier
application number: M017
MENTHOL 5%MENTHOL 5%Marcella Health30914c0a-fbda-5674-e063-6294a90aba5b2025-03-14WarningsExact identifier
application number: M017
Peppermint Soothing PatchCAMPHORIC ACID, MENTHOL, UNSPECIFIED FORMHenan Lijitang Medical Technology Co., Ltd.30361dd4-1f3d-ac5e-e063-6294a90a23bc2025-03-13WarningsExact identifier
application number: M017
AVCOO Menthol Pain Relief PatchMENTHOLADP Health Limited3036804b-16c3-0c88-e063-6394a90a30842025-03-13WarningsExact identifier
application number: M017
LIDOCAINE 4%LIDOCAINE 4%Marcella Health303d9462-cbfb-6251-e063-6394a90a70652025-03-13WarningsExact identifier
application number: M017
XeroBurn Burn GelLIDOCAINE HYDROCHLORIDEDynarex Corporation58985046-ca9c-12be-e053-2991aa0abe722025-03-13WarningsExact identifier
application number: M017
Post Treatment Repair CreamHYDROCORTISONEVege Labs LLC.302d4327-354b-a252-e063-6394a90a20b62025-03-12WarningsExact identifier
application number: M017
TheraCare Pain Relief 4% LidocaineLIDOCAINEVeridian Healthcare2d3fc030-5d53-2acd-e063-6294a90a11ab2025-03-11WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLVeridian Healthcare2d413707-794c-2fa8-e063-6394a90a06bf2025-03-11WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373219camphor 11 % / menthol 16 % Topical CreamPSN9979ff36-415b-44e4-bb10-6bf682cd00f97
1373219camphor 110 MG/ML / menthol 160 MG/ML Topical CreamSCD9979ff36-415b-44e4-bb10-6bf682cd00f97
1373219camphor 11 % / menthol 16 % Topical CreamSY9979ff36-415b-44e4-bb10-6bf682cd00f97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0801-0411670801001 TUBE in 1 CARTON (41167-0801-0) / 56 g in 1 TUBE1 tube2012-12-010000-00-00NoNoCurrent