FDA.reportPublic FDA data

Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On

Product NDC
41167-1709
11-digit product format
411671709
Labeler code
41167
Product ID
41167-1709_22e1aac4-eb1d-439d-b2f3-184bbca83130
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Chattem, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-03
Substance
MENTHOL
Active strength
8 g/100mL
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
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL8 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
727162Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aa40c907-eeb5-4fda-b35e-439cbecc178cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-1709-0Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On59 mL in 1 BOTTLELIQUID592
41167-1709-0Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-1709ICY HOT ORIGINAL NIGHTTIME RECOVERY PAIN RELIEF NO MESS ROLL ON (MENTHOL) LIQUID [CHATTEM, INC.]2Current NDC, 2 package rows20250110_aa40c907-eeb5-4fda-b35e-439cbecc178c.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 85 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROINNATE Numbing CreamMENTHOLGuangzhou Haishi Biological Technology Co., Ltd.39688b2b-c1fe-cd86-e063-6394a90a53452025-07-16WarningsExact identifier
application number: M017
Methyl SalicylateMETHYL SALICYLATEViolaCare, Inc.8f0ba6e7-8aa4-443e-99ae-a255085ddfec2025-07-15WarningsExact identifier
application number: M017
TopCare Hydrocortisone Intensive Healing FormulaHYDROCORTISONETopco Associates LLC7daafc44-e2a4-4f1b-bfca-3309a8e9a9202025-07-15WarningsExact identifier
application number: M017
Hydrocortisone Plus 12 MoisturizersHYDROCORTISONETARGET Corporation72c3889c-b743-4728-a315-6e4063e002002025-07-15WarningsExact identifier
application number: M017
Shopko Hydrocortisone Maximum StrengthHYDROCORTISONEShopko Stores Operating Co., LLC0431a6af-4c9a-4bbd-a535-cba31a5e53cc2025-07-15WarningsExact identifier
application number: M017
Freds Hydrocortisone with AloeHYDROCORTISONEFRED'S, INC.076503bf-8238-4739-bb1c-c385e72f8a962025-07-15WarningsExact identifier
application number: M017
Shopko HydrocortisoneHYDROCORTISONEShopko Stores Operating Co., LLC92bcbde3-401a-4301-854e-c352852317d62025-07-15WarningsExact identifier
application number: M017
TopCare HydrocortisoneHYDROCORTISONETopco Associates LLCbd3585fa-3b48-49b7-8ad1-749bf1e31ed52025-07-15WarningsExact identifier
application number: M017
Methyl Salicylate 25% Pain RelievingMETHYL SALICYLATEPuretek Corporation376797ff-cf13-a3c6-e063-6394a90a9de12025-07-15WarningsExact identifier
application number: M017
TIGER BALM PAIN RELIEVINGCAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.440e97bc-bd97-4733-9955-643b18e7fb182025-07-15WarningsExact identifier
application number: M017
Tiger Balm Pain Relieving Hydrogel LargeCAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.064d04ca-184d-492b-867c-beaa165ab3e02025-07-14WarningsExact identifier
application number: M017
Methyl Salicylate 25% CreamMETHYL SALICYLATEMedcore LLC143f76bf-2de4-466a-8a6b-d6ab6314a2c32025-07-14WarningsExact identifier
application number: M017
BLUESPRING Doctors Pain Formula Pain ReliefMENTHOLACA MANAGEMENT LLC98f3f719-792f-4a93-95b1-90072e0f8bf42025-07-14WarningsExact identifier
application number: M017
Shopko Anti-ItchDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEShopko Stores Operating Co., LLC130119eb-b87e-4a07-8d2a-317369bfa5412025-07-14WarningsExact identifier
application number: M017
Equate Hydrocortisone Intensive Healing FormulaHYDROCORTISONEWal-Mart Stores Inc.635b49c4-54d2-4b6d-bee8-851fc2c7ca9c2025-07-14WarningsExact identifier
application number: M017
ULTRA STRENGTH ZHENG GU SHUIMENTHOL AND CAMPHORGUANGXI YULIN PHARMACEUTICAL GROUP CO LTD53397663-044d-4e48-989b-2c6257af5f842025-07-14Warnings, Adverse reactionsExact identifier
application number: M017
TIGER BALM PAIN RELIEVING HYDROGELCAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.cb60037f-bceb-4090-a5e4-bdda0cbf9f5c2025-07-14WarningsExact identifier
application number: M017
Avedana Hydrocortisone Cream with AloeHYDROCORTISONEUnipack LLC2a55c426-39b4-4d94-b6b4-6c548c9685e92025-07-13WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE ACETATERite Aid Corporationcb6e0bed-2ea1-49d2-89e7-2554e7565b742025-07-11WarningsExact identifier
application number: M017
QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll OnLIDOCAINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION7b3ff4c1-0b60-4f7a-8aa4-c84b7c7137c42025-07-11WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727162menthol 8 % Topical SolutionPSNaa40c907-eeb5-4fda-b35e-439cbecc178c2
727162menthol 80 MG/ML Topical SolutionSCDaa40c907-eeb5-4fda-b35e-439cbecc178c2
727162menthol 8 % Topical SolutionSYaa40c907-eeb5-4fda-b35e-439cbecc178c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
41167-1709-0411671709001 BOTTLE in 1 CARTON (41167-1709-0) / 59 mL in 1 BOTTLE1 bottle2025-01-03NoNoCurrent