FDA.reportPublic FDA data

Icy Hot Pro Pain Massaging Balm

Product NDC
41167-0790
11-digit product format
411670790
Labeler code
41167
Product ID
41167-0790_ec4a6b9d-fcf6-45d6-ae11-6a625378bd18
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
2024-01-15
Substance
MENTHOL; CAMPHOR (SYNTHETIC)
Active strength
.16; .11 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
Icy Hot Pro Pain Massaging Balm
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
09e2b0cb-5186-4f9c-b256-edaced4ca014Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0790-0Icy Hot Pro Pain Massaging Balm35 g in 1 BOTTLECREAM356
41167-0790-0Icy Hot Pro Pain Massaging Balm1 in 1 CARTONCREAM16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0790ICY HOT PRO PAIN MASSAGING BALM (CAMPHOR AND MENTHOL) CREAM [CHATTEM, INC.]4Current NDC, 2 package rows20240911_09e2b0cb-5186-4f9c-b256-edaced4ca014.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 27 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPARTANLIDOCAINETIV PRIME SRL4e04146a-ed19-2271-e063-6394a90a50f02026-03-27WarningsExact identifier
application number: M017
Walgreens Pain Relieving LidocaineLIDOCAINEWalgreen Co.41d5bdc4-66c8-31ab-e063-6394a90a11952026-03-27WarningsExact identifier
application number: M017
Walgreens Cool N Heat PatchLIDOCAINE, MENTHOLWalgreen Co.41d64a88-90fc-27ca-e063-6294a90a602b2026-03-27WarningsExact identifier
application number: M017
Softlips Naturals MedicatedCAMPHOR, MENTHOLThe Mentholatum Company4e05d134-6c7f-1501-e063-6294a90ad27d2026-03-27WarningsExact identifier
application number: M017
Walgreens Cool N Heat Patch XLMENTHOLWalgreen Co.41e92435-7f77-a593-e063-6394a90a4b382026-03-27WarningsExact identifier
application number: M017
Walgreens Cool N Heat Back PatchMENTHOLWalgreen Co.41e81110-4b79-1fa6-e063-6394a90ae90c2026-03-27WarningsExact identifier
application number: M017
Softlips Naturals Medicated Elderberry AcaiCAMPHOR, MENTHOLThe Mentholatum Company4e0743a6-d450-043b-e063-6394a90ad1c22026-03-27WarningsExact identifier
application number: M017
QFSN Pain Relief CreamPAIN RELIEF CREAMQiaofusheng Pharmaceuticals Co., Ltd.4d215da1-87f5-d35d-e063-6394a90ac3482026-03-27WarningsExact identifier
application number: M017
FlexSport Roll OnMETHYL SALICYLATEPharmadel LLCbf8de3da-7628-6112-e053-2995a90a8e162026-03-26WarningsExact identifier
application number: M017
Kofal OriginalMETHYL SALICYLATEPharmadel LLC984780fd-496b-150b-e053-2995a90aed772026-03-26WarningsExact identifier
application number: M017
Kofal FuerteMETHYL SALICYLATEPharmadel LLC98488a07-eba0-2b4e-e053-2995a90ad6ab2026-03-26WarningsExact identifier
application number: M017
Kofal Max PowerMENTHOLPharmadel LLCfe1f1408-b0cb-67a4-e053-6394a90ad6092026-03-26WarningsExact identifier
application number: M017
KofalMETHYL SALICYLATEPharmadel LLC9cac377d-97bc-f0b7-e053-2a95a90a2e122026-03-26WarningsExact identifier
application number: M017
MilagrosoCAMPHORPharmadel LLC12b0401c-84d5-07cd-e063-6394a90a052c2026-03-26WarningsExact identifier
application number: M017
UbredolMETHYL SALICYLATEPharmadel LLCfe96eead-1722-c05d-e053-6394a90a850f2026-03-26WarningsExact identifier
application number: M017
DZUL PAIN FREEZE INSTANT PAIN RELIEFMENTHOLCaball Sales, Inc.4df3abcc-17f3-17f2-e063-6294a90afcca2026-03-26WarningsExact identifier
application number: M017
Equate Cool and Heat Extra StrengthMENTHOLWal-Mart Stores Incca3088a7-e1ec-4e69-80d9-fd0051bde9382026-03-25WarningsExact identifier
application number: M017
Ultra Strength Muscle Rub - CVS Health Ultra Strength Muscle RubCAMPHOR, MENTHOL, METHYL SALICYLATECVS Pharmacy2ea95529-ec4b-c2ce-e063-6394a90a07392026-03-25WarningsExact identifier
application number: M017
NUMBING CREAMSMENTHOL LIDOCAINEYongchun Lihui Trading Co., Ltd.4dd38cdf-d644-6da0-e063-6294a90afb3d2026-03-25WarningsExact identifier
application number: M017
ANTIPHLAMINEL-MENTHOL, L-CAMPHOR, METHYL SALICYLATEMasaem Company4dd3ab12-6cd3-1060-e063-6394a90a2dec2026-03-25WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
41167-0790-0411670790001 BOTTLE in 1 CARTON (41167-0790-0) / 35 g in 1 BOTTLE1 bottle2024-01-15NoNoCurrent