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 67 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
StallionDELAY CREMENovelties by Nasswalk, Inc.0261ec88-8fe4-d5f8-e063-6294a90ab3d42025-11-10WarningsExact identifier
application number: M017
ANAL-ESEDESENSITIZERNovelties by Nasswalk, Inc.03b89eed-b433-a263-e063-6294a90a675b2025-11-10WarningsExact identifier
application number: M017
Instant ErectionULTIMATE ERECTION ENHANCERNovelties by Nasswalk, Inc.03a444f9-7052-0c38-e063-6294a90a4e562025-11-10WarningsExact identifier
application number: M017
STA-HARDDESENSITIZING LUBRICANTNovelties by Nasswalk, Inc.02ef794b-8e70-5c26-e063-6294a90a28d12025-11-10WarningsExact identifier
application number: M017
ANAL-ESEDESENSITIZERNovelties by Nasswalk, Inc.03a4a7ce-4cff-a608-e063-6294a90ad65d2025-11-10WarningsExact identifier
application number: M017
FOOTSPA PEDIALCOHOLCHEMCO CORPORATION04de4392-74f6-7df8-e063-6294a90ae3b12025-11-08WarningsExact identifier
application number: M017
Johnson and Johnson All Purpose First Aid KitACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC5cdb47c5-7951-4279-8a05-0a3199d3dd452025-11-06WarningsExact identifier
application number: M017
Johnson and Johnson First Aid Travel Ready 80 CTACETAMINOPHEN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEKenvue Brands LLCf388f105-48ba-4616-e053-2a95a90a00492025-11-06WarningsExact identifier
application number: M017
Johnson and Johnson First Aid All Purpose 160 CTACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLCf3933330-2550-4a88-e053-2a95a90a39972025-11-06WarningsExact identifier
application number: M017
Foot and Leg Pain ReliefLIDOCAINEPremier Brands of America Inc.42f23e2f-11c6-da49-e063-6294a90ac7202025-11-06WarningsExact identifier
application number: M017
HEALING TREE CALMING ANTI-ITCHHYDROCORTISONERenu Laboratories, LLCfc8bcde9-26e8-a35f-e053-6394a90a33002025-11-06WarningsExact identifier
application number: M017
Calamine PlusCALAMINE PLUS PRAMOXINE HCLChain Drug Marketing Association Inc1a3f8819-58cf-8923-e063-6394a90a37af2025-11-06WarningsExact identifier
application number: M017
Extra Strength Itch ReliefDIPHENHYDRAMINE HCL AND ZINC ACETATEChain Drug Marketing Association Inc1a2997bc-7741-e658-e063-6394a90af6fd2025-11-06WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAYTopco Associates LLC8026c7dd-eb7b-ebea-e053-2991aa0a1b0f2025-11-06WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEFWalgreen Company6057b4ff-6adc-4688-893c-62d237d7d1ae2025-11-06WarningsExact identifier
application number: M017
BANPINGHUA Glucosamine Chondroitin PatchPEPPERMINT, CAMPHOR, BORNEOLHenan Lijitang Medical Technology Co., Ltd.42f8c2ae-50a2-2358-e063-6394a90a59792025-11-06WarningsExact identifier
application number: M017
PAINGELCAMPHOR, MENTHOLNACOR BUSINESS GROUP LLC42fa2397-b61a-3b16-e063-6294a90a5fed2025-11-06WarningsExact identifier
application number: M017
PAINGEL UNGUENTOCAMPHOR, MENTHOLNACOR BUSINESS GROUP LLC42fab525-b0a5-97fb-e063-6394a90aec6c2025-11-06WarningsExact identifier
application number: M017
PAINGEL ROLL-ONMENTHOLNACOR BUSINESS GROUP LLC42fb0bdf-8bbd-bbe3-e063-6294a90a656c2025-11-06WarningsExact identifier
application number: M017
CoolexaCAMPHOR, MENTHOL, METHYL SALICYLATERising Pharma Holdings, Inc.38839f29-d4ce-4684-a3c7-0bb4bf1ad5942025-11-06WarningsExact 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