FDA.reportPublic FDA data

Muscle Freeze Relief

Product NDC
66902-410
11-digit product format
669020410
Labeler code
66902
Product ID
66902-410_240d1402-4d06-62ff-e063-6294a90ad60c
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
NATURAL ESSENTIALS, INC.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-15
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
37 mg/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
Muscle Freeze Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM37 mg/g

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
1192745Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
815c534b-096d-49f2-b5f2-8c885d45a5e6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66902-410-03Muscle Freeze Relief85 g in 1 CONTAINERGEL853
66902-410-04Muscle Freeze Relief113 g in 1 BOTTLEGEL1133
66902-410-15Muscle Freeze Relief425 g in 1 BOTTLEGEL4253
66902-410-16Muscle Freeze Relief453 g in 1 BOTTLEGEL4533
66902-410-28Muscle Freeze Relief3629 g in 1 JUGGEL36293
66902-410-55Muscle Freeze Relief195498 g in 1 DRUMGEL1954983

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66902-410MUSCLE FREEZE RELIEF (MENTHOL) GEL [NATURAL ESSENTIALS, INC.]3Current NDC, Legacy NDC, 6 package rows20241011_815c534b-096d-49f2-b5f2-8c885d45a5e6.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 151 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EXOTEN-CMETHYL SALICYLATE, MENTHOL, CAPSAICINAsclemed USA, Inc.76ed37e0-64b5-4abe-a03c-3dc7084a39192023-10-16WarningsExact identifier
application number: M017
Calypxo Pain ReliefMETHYL SALICYLATE, MENTHOLAsclemed USA, Incbd9d0bc0-5705-4c73-bcd6-f6cdb68e05b62023-10-16WarningsExact identifier
application number: M017
Calypxo HP Pain ReliefMETHYL SALICYLATE, MENTHOLAsclemed USA, Inc89a8c267-bd92-4d0d-8e50-c52224aff9cd2023-10-16WarningsExact identifier
application number: M017
ZylotrolLIDOCAINE HCL 4%, MENTHOL 1%Whitestone Products LLC0e32e9c0-ff5b-4e88-89b1-f5903cd982092023-10-16WarningsExact identifier
application number: M017
CapsadynCAPSAICINChorda Pharma, Inc07731045-0d2b-76b7-e063-6294a90af9212023-10-11WarningsExact identifier
application number: M017
WHITE FLOWER STRAIN RELIEFCAMPHOR, MENTHOL AND METHYL SALICYLATEHOE HIN PAK FAH YEOW MANUFACTORY LTD65282267-de63-453a-a686-f8752c71b9ef2023-10-02WarningsExact identifier
application number: M017
WHITE FLOWER ANALGESIC BALM FLORAL SCENTEDCAMPHOR, MENTHOL AND METHYL SALICYLATEHOE HIN PAK FAH YEOW MANUFACTORY LTD4e9cb5aa-b0aa-4a5c-b561-cc38437758d82023-10-02WarningsExact identifier
application number: M017
NATUREANCE BODY BALMCAMPHOREROS GLOBAL CORP05b84fd2-8d8f-9249-e063-6294a90ae29f2023-09-19WarningsExact identifier
application number: M017
U ICE COLDMENTHOLUNIVERSAL DISTRIBUTION CENTER LLC752ef0cd-f12a-3b9e-e053-2991aa0abeb12023-09-01WarningsExact identifier
application number: M017
Family Wellness Pain Relief with LidocainePAIN RELIEF WITH LIDOCAINEFAMILY DOLLAR (Family Wellness)3a18119f-6c75-4cea-a990-97cb8a9589d42023-08-29WarningsExact identifier
application number: M017
Bactine Max Antibiotic and Lidocaine Max Pain ReliefLIDOCAINEWellSpring Pharmaceutical Corporation71300df9-6113-4f25-93ca-28ad7e7f79de2023-06-08WarningsExact identifier
application number: M017
Bactine Max Lidocaine Roll-on 2.5ozLIDOCAINEWellSpring Pharmaceutical Corporation09b32a98-9131-451e-87a6-81a1e4ed7ec52023-04-25WarningsExact identifier
application number: M017
Icy Hot Pro DryCAMPHOR, MENTHOLChattem, Inc.4de1bc29-d166-4599-9e75-5f841bf209672023-03-01WarningsExact identifier
application number: M017
Icy Hot Vanishing ScentMENTHOLChattem, Inc.e2092016-9741-433d-92e6-74bfddadb72c2022-09-29WarningsExact identifier
application number: M017
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLAlexso, Inc5dbd5fc0-a27e-4979-aca7-28f73096fd5f2022-08-18WarningsExact identifier
application number: M017
FIRSTAR Sting Relief PadBENZOCAINEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.0e491a7a-4204-439f-862d-741cbc0be9fd2021-07-06WarningsExact identifier
application number: M017
Arthritis Relief GoodSenseTROLAMINE SALICYLATEGeiss, Destin & Dunn, Inca253730a-2187-07de-e053-2a95a90a98772020-04-02WarningsExact identifier
application number: M017
Aloe CortHYDROCORTISONETopiderm, Inc.789a6669-3320-4558-8d6f-ab255db50d8d2019-09-17WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On RefreshCAMPHOR, MENTHOLBorden Company (Private) Limited567b6820-fb52-630e-e063-6294a90a8bf82015-07-01WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEBorden Company (Private) Limited54e45d89-e8c3-6fc3-e063-6394a90aac4e2015-06-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1192745menthol 3.7 % Topical GelPSN815c534b-096d-49f2-b5f2-8c885d45a5e63
1192745menthol 0.037 MG/MG Topical GelSCD815c534b-096d-49f2-b5f2-8c885d45a5e63
1192745menthol 3.7 % Topical GelSY815c534b-096d-49f2-b5f2-8c885d45a5e63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66902-410-036690204100385 g in 1 CONTAINER (66902-410-03) 85 g2021-07-150000-00-00NoNoCurrent
66902-410-0466902041004113 g in 1 BOTTLE (66902-410-04) 113 g2021-07-150000-00-00NoNoCurrent
66902-410-1566902041015425 g in 1 BOTTLE (66902-410-15) 425 g2021-12-070000-00-00NoNoCurrent
66902-410-1666902041016453 g in 1 BOTTLE (66902-410-16) 453 g2021-07-150000-00-00NoNoCurrent
66902-410-28669020410283629 g in 1 JUG (66902-410-28) 3629 g2021-07-150000-00-00NoNoCurrent
66902-410-5566902041055195498 g in 1 DRUM (66902-410-55) 195498 g2021-07-150000-00-00NoNoCurrent