FDA.reportPublic FDA data

Katinko External Analgesic Oil

Product NDC
52241-301
11-digit product format
522410301
Labeler code
52241
Product ID
52241-301_0c0ca95f-4185-c869-e063-6294a90af71b
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE
Dosage form
OIL
Route
TOPICAL
Labeler
Greenstone Pharmaceutical Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-01
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
50; 160; 300 mg/mL; mg/mL; mg/mL
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
Katinko External Analgesic Oil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)50 mg/mL
MENTHOL160 mg/mL
METHYL SALICYLATE300 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2637881Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5881fc35-3293-4f0b-801a-afcd6feb9496Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52241-301-01Katinko External Analgesic Oil1 in 1 CARTONOIL12
52241-301-01Katinko External Analgesic Oil10 mL in 1 BOTTLEOIL102
52241-301-02Katinko External Analgesic Oil35 mL in 1 BOTTLE, GLASSOIL352
52241-301-02Katinko External Analgesic Oil1 in 1 CARTONOIL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52241-301KATINKO EXTERNAL ANALGESIC OIL (CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE) OIL [GREENSTONE PHARMACEUTICAL INC.]2Current NDC, 4 package rows20231210_5881fc35-3293-4f0b-801a-afcd6feb9496.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 74 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROINNATE Numbing CreamMENTHOLGuangzhou Haishi Biological Technology Co., Ltd.40c63645-8ed3-82b3-e063-6294a90a52672025-10-13WarningsExact identifier
application number: M017
CramergesicMENTHOL, METHYL SALICYLATEThe Hygenic Company, LLCd0ffde7a-6942-74fc-e053-2a95a90a484a2025-10-13WarningsExact identifier
application number: M017
TricylateMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATETrifluent Pharma LLC4869b63a-e01e-4a79-a493-7a1b4d3e914b2025-10-13WarningsExact identifier
application number: M017
Doloflex Pain ReliefMENTHOL, METHYL SALICYLATEUnited Health & Beauty Corp32a830cc-04d3-102e-e063-6294a90a1cad2025-10-12WarningsExact identifier
application number: M017
Lidocaine Pain Relieving Gel-PatchLIDOCAINENanjing Anxing Medical Technology Co., Ltd.40c9b132-57ce-865e-e063-6394a90a20802025-10-10WarningsExact identifier
application number: M017
KinesysZINC OXIDEWilc Healthcare Inca32b44c3-eda0-48ea-95fc-250a2c2396ca2025-10-10WarningsExact identifier
application number: M017
Te-Fu Recovery MassageMENTHOL, METHYL SALICYLATEWasatch Product Development7bc2989f-dfb6-e8af-e053-2991aa0a0bf22025-10-10WarningsExact identifier
application number: M017
Anti-itchHYDROCORTISONEMedline Industries, LPb0947381-c0db-4253-ab40-3d45603ae65d2025-10-09WarningsExact identifier
application number: M017
Kalaya Pain ReliefMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpe2452c4b-2548-497f-828b-5d960402522a2025-10-08WarningsExact identifier
application number: M017
Kalaya Pain Relief 6X with ArnicaPAIN RELIEF CREAMAvaria Health & Beauty Corp60198d2e-4de3-3fa0-e053-2a91aa0afaf72025-10-08WarningsExact identifier
application number: M017
KALAYA PAIN RELIEF 6X WITH ARNICA - Pain ReliefMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp9b9b7cad-a5e2-4445-856b-4aa439d77a802025-10-08WarningsExact identifier
application number: M017
KALAYA FOAMING PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpd5021e6d-f29f-446b-874c-bdcabd9cf4f62025-10-08WarningsExact identifier
application number: M017
KALAYA EXTRA STRENGTH FOAMING PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpe0c9f22a-165a-4558-ba3c-8592f1bd00162025-10-08WarningsExact identifier
application number: M017
Kalaya Extra Strength Pain Relief Cream with Hemp Seed OilMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp2eccf23c-fae2-423c-9cae-549bc41941042025-10-08WarningsExact identifier
application number: M017
KALAYA BACK AND NECK PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp48fd73e7-1443-4ac7-bf7c-d99bf2449f512025-10-08WarningsExact identifier
application number: M017
Lidocaine Pain Relieving PatchLIDOCAINE 4%BluePoint Laboratories3117273d-e006-2726-e063-6294a90a9c332025-10-08WarningsExact identifier
application number: M017
EQUATE PAIN RELIEVING PATCHESLIDOCAINE 4%WALMART, INC01e1cc0e-e1c9-d274-e063-6294a90a409e2025-10-08WarningsExact identifier
application number: M017
Equate Pain Relief BalmMENTHOL 11%, CAMPHOR 11% OINTMENTWALMART, INCd8ddf835-f008-ce1f-e053-2a95a90aa9b32025-10-08WarningsExact identifier
application number: M017
TheraCare Pain Relieving Menthol GelMENTHOL 2%Veridian Healthcare9d2ccb02-746c-4cb9-905d-280987778f4d2025-10-08WarningsExact identifier
application number: M017
COOLING PAIN RELIEFMENTHOL, CAMPHORSUNSET NOVELTIES, INC3a9019b1-8798-1ef9-e063-6394a90a09a42025-10-08WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637881camphor 5 % / menthol 16 % / methyl salicylate 30 % Topical OilPSN5881fc35-3293-4f0b-801a-afcd6feb94962
2637881camphor 50 MG/ML / menthol 160 MG/ML / methyl salicylate 300 MG/ML Topical OilSCD5881fc35-3293-4f0b-801a-afcd6feb94962
2637881camphor 5 % / menthol 16 % / methyl salicylate 30 % Topical OilSY5881fc35-3293-4f0b-801a-afcd6feb94962

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52241-301-01522410301011 BOTTLE in 1 CARTON (52241-301-01) / 10 mL in 1 BOTTLE1 bottle2023-06-01NoNoCurrent
52241-301-02522410301021 BOTTLE, GLASS in 1 CARTON (52241-301-02) / 35 mL in 1 BOTTLE, GLASS2023-06-01NoNoCurrent