FDA.reportPublic FDA data

KALAYA EXTRA STRENGTH FOAMING PAIN RELIEF

Product NDC
43493-0010
Requested package NDC
43493-0010-0
11-digit product format
434930010
Labeler code
43493
Product ID
43493-0010_40a7d5ab-0023-267f-e063-6394a90a4c14
Type
HUMAN OTC DRUG
Nonproprietary name
methyl salicylate, menthol, camphor
Dosage form
LIQUID
Route
TOPICAL
Labeler
Avaria Health & Beauty Corp
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-10
Substance
METHYL SALICYLATE; MENTHOL; CAMPHOR (NATURAL)
Active strength
15; 8; 3 g/100mL; g/100mL; g/100mL
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
KALAYA EXTRA STRENGTH FOAMING PAIN RELIEF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE15 g/100mL
MENTHOL8 g/100mL
CAMPHOR (NATURAL)3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
L7T10EIP3AInternal UNII lookup
N20HL7Q941Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2629983Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e0c9f22a-165a-4558-ba3c-8592f1bd0016Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43493-0010-0KALAYA EXTRA STRENGTH FOAMING PAIN RELIEF1 in 1 BOXLIQUID13
43493-0010-0KALAYA EXTRA STRENGTH FOAMING PAIN RELIEF80 mL in 1 BOTTLE, SPRAYLIQUID803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43493-0010KALAYA EXTRA STRENGTH FOAMING PAIN RELIEF (METHYL SALICYLATE, MENTHOL, CAMPHOR) LIQUID [AVARIA HEALTH & BEAUTY CORP]2Current NDC, 2 package rows20241121_e0c9f22a-165a-4558-ba3c-8592f1bd0016.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 70 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coralite Ultra Strength Pain ReliefCAMPHOR MENTHOLUnited Exchange Corp.44ecf959-cc07-4adc-a500-075b2ee695482025-10-29WarningsExact identifier
application number: M017
GoodSense Pain ReliefLIDOCAINEGeiss, Destin & Dunn, Inc826f8da4-8468-ea0a-e053-2991aa0a66cb2025-10-28WarningsExact identifier
application number: M017
CALMADOLCAMPHOR, MENTHOL, METHYL SALICYLATEGRANDALL DISTRIBUTING, LLC31b7f84e-8b66-4d31-8e9c-279d0af2fe642025-10-28WarningsExact identifier
application number: M017
XRay DOLCAMPHOR, MENTHOL, AND METHYL SALICYLATEGenomma Lab USA, Inc.e07fef46-68d9-769c-e053-2a95a90aa0652025-10-28WarningsExact identifier
application number: M017
CVS Medicated HeatCAPSICUM EXTRACTCVS Pharmacy81cd1019-93a6-311b-e053-2991aa0a79972025-10-28WarningsExact identifier
application number: M017
Foster and ThriveLIDOCAINESTRATEGIC SOURCING SERVICES, LLCf950b072-d978-b629-e053-6394a90abfaf2025-10-28WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYPremier Brands of America, Inc.d3452573-f91f-f157-e053-2a95a90a1ad82025-10-27WarningsExact identifier
application number: M017
PRMENTHOLAmphp, Inc6f5b9e08-c445-4fac-e053-2a91aa0aa7372025-10-27WarningsExact identifier
application number: M017
LidocaineBURN RELIEFFoodhold USAb25dc0df-02d0-41ac-b36c-2c04baa77ef22025-10-27WarningsExact identifier
application number: M017
MentholMAXIMUM STRENGTH MEDICATED FOOT POWDER TALC FREEFSA Store Inc.fb3548c8-f202-dc50-e053-6394a90a5b302025-10-27WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE CONTINUOUS SPRAYPremier Brands of America, Inc.d344f68b-9b62-3029-e053-2995a90a16652025-10-27WarningsExact identifier
application number: M017
Medi-First Hydrocortisone 1%HYDROCORTISONE ACETATE 1%Unifirst First Aid Corporationf2b46d69-1c21-5ae9-e053-2a95a90a60a92025-10-24WarningsExact identifier
application number: M017
Extra StrengthMENTHOL AND METHYL SALICYLATESaje Natural Business Inc.87d872b3-3231-d0f2-e053-2995a90a9d982025-10-24WarningsExact identifier
application number: M017
Coralite Muscle and Joint Pain ReliefCAMPHOR, MENTHOL, AND MEHTYL SALICYLATEUnited Exchange Corporation78edeeb8-3e3c-64bb-e053-2a91aa0a7bbc2025-10-24WarningsExact identifier
application number: M017
Coralite Odor Free Pain ReliefLIDOCAINEUnited Exchange Corporation7966d9f2-22f9-a900-e053-2991aa0aba552025-10-24WarningsExact identifier
application number: M017
Signature Care Cold and HotMENTHOL, AND METHYL SALICYLATESafeway Inc.ab201023-e3dc-52ec-e053-2995a90a1f182025-10-24WarningsExact identifier
application number: M017
HealthWise Medicated Cold Hot 5% PatchMENTHOLVeridian Healthcare15aef56f-cd25-05ac-e063-6394a90a07bb2025-10-23WarningsExact identifier
application number: M017
AlivioLIDOCAINEAmerise Pharmaceuticals LLCeb3a98f1-c875-4f08-8b4b-44e22626b6092025-10-23WarningsExact identifier
application number: M017
Pain Relieveing Gel-PatchLIDOCAINEBullet point LLC41d507c4-ad37-2686-e063-6394a90aae5b2025-10-23WarningsExact identifier
application number: M017
ActivICEMENTHOLMedline Industries, LP98fa9a34-0e1e-0997-e053-2a95a90ac77d2025-10-23WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2629983camphor 3 % / menthol 8 % / methyl salicylate 15 % Topical FoamPSNe0c9f22a-165a-4558-ba3c-8592f1bd00163
2629983camphor 30 MG/ML / menthol 80 MG/ML / methyl salicylate 150 MG/ML Topical FoamSCDe0c9f22a-165a-4558-ba3c-8592f1bd00163
2629983camphor 3 % / menthol 8 % / methyl salicylate 15 % Topical FoamSYe0c9f22a-165a-4558-ba3c-8592f1bd00163

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43493-0010-0434930010001 BOTTLE, SPRAY in 1 BOX (43493-0010-0) / 80 mL in 1 BOTTLE, SPRAY2023-02-10NoNoCurrent