FDA.reportPublic FDA data

Icy Hot

Product NDC
41167-0088
11-digit product format
411670088
Labeler code
41167
Product ID
41167-0088_246dae26-59de-4caa-931f-6df0463a6acf
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol and Methyl Salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
Chattem, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1991-06-01
Substance
MENTHOL; METHYL SALICYLATE
Active strength
10; 30 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41167-008841167-0088-8DDiscontinued by firm2026-10-20

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
Brand name suffix
Pain Relieving Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL10 g/100g
METHYL SALICYLATE30 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311500Internal RxNorm lookup
311510Internal RxNorm lookup
1044268Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
40c8c02f-fa5f-4e80-81a0-48271fa6f94bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0088-1Icy HotPain Relieving Cream85 g in 1 TUBECREAM8516
41167-0088-1Icy HotPain Relieving Cream1 in 1 CARTONCREAM116
41167-0088-5Icy HotPain Relieving Cream35.4 g in 1 TUBECREAM35.416
41167-0088-5Icy HotPain Relieving Cream1 in 1 CARTONCREAM116
41167-0088-8Icy HotPain Relieving Cream44 g in 1 TUBECREAM4416
41167-0088-8Icy HotPain Relieving Cream1 in 1 CARTONCREAM116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-0088-1GM - Gram41167-008832a8d1a7-ab44-4156-a09c-e21b9e1859d812021-08-05
41167-0088-5GM - Gram41167-00887842dfa3-3a3a-4cd5-a54f-47ae0d73f2a112021-08-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AICY HOT (MENTHOL AND METHYL SALICYLATE) STICK ICY HOT (MENTHOL AND METHYL SALICYLATE) OINTMENT ICY HOT (MENTHOL AND METHYL SALICYLATE) CREAM [CHATTEM, INC.]3
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YICY HOT (MENTHOL AND METHYL SALICYLATE) STICK ICY HOT (MENTHOL AND METHYL SALICYLATE) OINTMENT ICY HOT (MENTHOL AND METHYL SALICYLATE) CREAM [CHATTEM, INC.]3
MENTHOLACTIVE MOIETYL7T10EIP3AICY HOT (MENTHOL AND METHYL SALICYLATE) STICK ICY HOT (MENTHOL AND METHYL SALICYLATE) OINTMENT ICY HOT (MENTHOL AND METHYL SALICYLATE) CREAM [CHATTEM, INC.]3
METHYL SALICYLATEACTIVE MOIETYLAV5U5022YICY HOT (MENTHOL AND METHYL SALICYLATE) STICK ICY HOT (MENTHOL AND METHYL SALICYLATE) OINTMENT ICY HOT (MENTHOL AND METHYL SALICYLATE) CREAM [CHATTEM, INC.]3
CERESININACTIVE INGREDIENTQ1LS2UJO3AICY HOT (MENTHOL AND METHYL SALICYLATE) STICK ICY HOT (MENTHOL AND METHYL SALICYLATE) OINTMENT ICY HOT (MENTHOL AND METHYL SALICYLATE) CREAM [CHATTEM, INC.]3
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUICY HOT (MENTHOL AND METHYL SALICYLATE) STICK ICY HOT (MENTHOL AND METHYL SALICYLATE) OINTMENT ICY HOT (MENTHOL AND METHYL SALICYLATE) CREAM [CHATTEM, INC.]3
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZICY HOT (MENTHOL AND METHYL SALICYLATE) STICK ICY HOT (MENTHOL AND METHYL SALICYLATE) OINTMENT ICY HOT (MENTHOL AND METHYL SALICYLATE) CREAM [CHATTEM, INC.]3
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYICY HOT (MENTHOL AND METHYL SALICYLATE) STICK ICY HOT (MENTHOL AND METHYL SALICYLATE) OINTMENT ICY HOT (MENTHOL AND METHYL SALICYLATE) CREAM [CHATTEM, INC.]3
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYICY HOT (MENTHOL AND METHYL SALICYLATE) STICK ICY HOT (MENTHOL AND METHYL SALICYLATE) OINTMENT ICY HOT (MENTHOL AND METHYL SALICYLATE) CREAM [CHATTEM, INC.]3
OLETH-3 PHOSPHATEINACTIVE INGREDIENT8Q0Z18J1VLICY HOT (MENTHOL AND METHYL SALICYLATE) STICK ICY HOT (MENTHOL AND METHYL SALICYLATE) OINTMENT ICY HOT (MENTHOL AND METHYL SALICYLATE) CREAM [CHATTEM, INC.]3
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEICY HOT (MENTHOL AND METHYL SALICYLATE) STICK ICY HOT (MENTHOL AND METHYL SALICYLATE) OINTMENT ICY HOT (MENTHOL AND METHYL SALICYLATE) CREAM [CHATTEM, INC.]3
PEG-150 DISTEARATEINACTIVE INGREDIENT6F36Q0I0ACICY HOT (MENTHOL AND METHYL SALICYLATE) STICK ICY HOT (MENTHOL AND METHYL SALICYLATE) OINTMENT ICY HOT (MENTHOL AND METHYL SALICYLATE) CREAM [CHATTEM, INC.]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UICY HOT (MENTHOL AND METHYL SALICYLATE) STICK ICY HOT (MENTHOL AND METHYL SALICYLATE) OINTMENT ICY HOT (MENTHOL AND METHYL SALICYLATE) CREAM [CHATTEM, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ICY HOT (MENTHOL AND METHYL SALICYLATE) STICK ICY HOT (MENTHOL AND METHYL SALICYLATE) OINTMENT ICY HOT (MENTHOL AND METHYL SALICYLATE) CREAM [CHATTEM, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APICY HOT (MENTHOL AND METHYL SALICYLATE) STICK ICY HOT (MENTHOL AND METHYL SALICYLATE) OINTMENT ICY HOT (MENTHOL AND METHYL SALICYLATE) CREAM [CHATTEM, INC.]3
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YICY HOT (MENTHOL AND METHYL SALICYLATE) STICK ICY HOT (MENTHOL AND METHYL SALICYLATE) OINTMENT ICY HOT (MENTHOL AND METHYL SALICYLATE) CREAM [CHATTEM, INC.]3
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKICY HOT (MENTHOL AND METHYL SALICYLATE) STICK ICY HOT (MENTHOL AND METHYL SALICYLATE) OINTMENT ICY HOT (MENTHOL AND METHYL SALICYLATE) CREAM [CHATTEM, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RICY HOT (MENTHOL AND METHYL SALICYLATE) STICK ICY HOT (MENTHOL AND METHYL SALICYLATE) OINTMENT ICY HOT (MENTHOL AND METHYL SALICYLATE) CREAM [CHATTEM, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0088ICY HOT PAIN RELIEVING STICK (MENTHOL AND METHYL SALICYLATE) STICK ICY HOT PAIN RELIEVING BALM (MENTHOL AND METHYL SALICYLATE) OINTMENT ICY HOT PAIN RELIEVING CREAM (MENTHOL AND METHYL SALICYLATE) CREAM [CHATTEM, INC.]15Current NDC, Legacy NDC, 6 package rows20240807_40c8c02f-fa5f-4e80-81a0-48271fa6f94b.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 9 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4dfc77bb-11dd-e0f0-e063-6294a90a4e9c2026-07-24WarningsExact identifier
application number: M017
DRAVYNOR QUIT SMOKING PatchesNICOTINE18% MENTHOL 0.3% QUIT SMOKING PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.5768631f-d517-5b43-e063-6294a90a8f462026-07-24WarningsExact identifier
application number: M017
DERMFREE NUMBINGLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a5b47ce-2bf1-42c7-e063-6294a90af09f2026-07-23WarningsExact identifier
application number: M017
DERMFREE WART CORN REMOVERSALICYLIC ACID 40% WART CORN REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a5c63b3-44de-8736-e063-6394a90ac21a2026-07-23WarningsExact identifier
application number: M017
DERMFREE Anti-itchHYDROCORTISONE1% ANTI-ITCHJiangxi Yudexi Pharmaceutical Co., LTD4a5af4c6-555a-e74c-e063-6394a90aa6ce2026-07-23WarningsExact identifier
application number: M017
DERMFREE HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4a5d0e79-d620-0147-e063-6294a90a31032026-07-23WarningsExact identifier
application number: M017
MAG 5 PT WARMING FORMULAMENTHOLRENU LABORATORIES, LLCa499ac9b-0e8e-e23f-e053-2a95a90abe9a2026-07-23WarningsExact identifier
application number: M017
Icy Hot Performance Cream Pain ReliefMENTHOL 16%, CAMPHOR 11%Chattem, Inc.73f7a113-ef11-4932-bf4d-4e62863f79412026-07-23WarningsExact identifier
application number: M017
Numbing Pain ReliefLIDOCAINE 4%Walgreen Company2425badb-e196-e9f8-e063-6294a90a7bf42026-07-22WarningsExact identifier
application number: M017
Cooling Pain ReliefMENTHOL 4.5%Walgreen Company24345ccf-c96f-31b0-e063-6294a90a82b52026-07-22WarningsExact identifier
application number: M017
Heat Pain ReliefCAPSAICIN 0.1%Walgreen Company2434f9cf-74aa-17af-e063-6294a90a56d92026-07-22WarningsExact identifier
application number: M017
Pain Relief Patch LidocaineLIDOCAINEHyVee41c26a66-3371-2c2c-e063-6294a90aa38b2026-07-22WarningsExact identifier
application number: M017
CVS Ultra Strength MuscleMENTHOL, CAMPHOR, METHYL SALICYLATECVS Pharmacy48bef8bc-6e39-a328-e063-6394a90ae4502026-07-22WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEAKRON PHARMA INCdaad9a1e-98d2-4ce7-9d97-ac5d81905abb2026-07-22WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pain RelievingMENTHOL, CAMPHORActive and Innovative573c2d85-9e0b-7955-e063-6394a90aff642026-07-22WarningsExact identifier
application number: M017
DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEFBENZALKONIUM CHLORIDE, LIDOCAINEEnviro Specialty Chemicals Incf7abe66c-dc2d-4ef7-9b11-5b87157fd3022026-07-21WarningsExact identifier
application number: M017
Bclsks NUMBINGMENTHOL 1% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD49e26770-ddf6-7515-e063-6394a90a4ab32026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE21MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5e9691-727f-6bcd-e063-6294a90aadfc2026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE14MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5eec19-7f9a-d277-e063-6294a90ace952026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE7MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5f124e-2dd7-16b8-e063-6294a90a5cdb2026-07-21WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311500menthol 10 % / methyl salicylate 30 % Topical CreamPSN40c8c02f-fa5f-4e80-81a0-48271fa6f94b16
1044268menthol 10 % / methyl salicylate 30 % Topical StickPSN40c8c02f-fa5f-4e80-81a0-48271fa6f94b16
311510menthol 7.6 % / methyl salicylate 29 % Topical OintmentPSN40c8c02f-fa5f-4e80-81a0-48271fa6f94b16
311510menthol 0.076 MG/MG / methyl salicylate 0.29 MG/MG Topical OintmentSCD40c8c02f-fa5f-4e80-81a0-48271fa6f94b16
1044268menthol 0.1 MG/MG / methyl salicylate 0.3 MG/MG Topical OintmentSCD40c8c02f-fa5f-4e80-81a0-48271fa6f94b16
311500menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD40c8c02f-fa5f-4e80-81a0-48271fa6f94b16
311500menthol 10 % / methyl salicylate 30 % Topical CreamSY40c8c02f-fa5f-4e80-81a0-48271fa6f94b16
1044268menthol 10 % / methyl salicylate 30 % Topical StickSY40c8c02f-fa5f-4e80-81a0-48271fa6f94b16
311510menthol 7.6 % / methyl salicylate 29 % Topical SalveSY40c8c02f-fa5f-4e80-81a0-48271fa6f94b16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0088-1411670088011 TUBE in 1 CARTON (41167-0088-1) / 85 g in 1 TUBE1 tube1991-06-010000-00-00NoNoCurrent
41167-0088-5411670088051 TUBE in 1 CARTON (41167-0088-5) / 35.4 g in 1 TUBE1 tube1991-06-010000-00-00NoNoCurrent
41167-0088-8411670088081 TUBE in 1 CARTON (41167-0088-8) > 44 g in 1 TUBE1 tube1991-06-010000-00-00NoNoCurrent