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 46 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine 4% Topical Anesthetic CreamLIDOCAINE 4%Oncor Pharmaceuticals1baaa669-05af-4024-a0ba-ee3451756f6a2026-01-05WarningsExact identifier
application number: M017
TheraCare Pain ReliefMENTHOLVeridian Healthcare6834a6de-4d1d-4e40-945d-ec5c267abd142026-01-05WarningsExact identifier
application number: M017
TheraCare Lidocaine Pain ReliefLIDOCAINEVeridian Healthcareee8cd550-64ee-432e-98e5-b68083179a3c2026-01-05WarningsExact identifier
application number: M017
REGENECARE HALIDOCAINE HCLMPM Medical LLC0eee554f-dfe0-433a-9665-8bdb952298882026-01-05WarningsExact identifier
application number: M017
Pain Relieving CreamCAMPHOR AND MENTHOLPAIN WIZARD LIMITED LIABILITY COMPANY2647bba1-87f4-3c16-e063-6394a90ae0c92026-01-05WarningsExact identifier
application number: M017
TheraCare Lidocaine plus MentholLIDOCAINE, MENTHOLVeridian Healthcareefddd116-d753-425a-9ded-09b8045024e42026-01-05WarningsExact identifier
application number: M017
TheraCare Original MentholMENTHOLVeridian Healthcareea56e4e1-a758-428b-8758-ee31bb00ca822026-01-05WarningsExact identifier
application number: M017
Mugwort Patch (Cervical spine use)2%MENTHOLYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED478e220c-0d35-9ee0-e063-6294a90ab6892026-01-04WarningsExact identifier
application number: M017
Mugwort Patch (Lumbar spine use)2%MENTHOLYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED478e4b21-6d81-4cd3-e063-6394a90a18fe2026-01-04WarningsExact identifier
application number: M017
Mugwort Patch (Knee use)2%MENTHOLYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED478e86d2-3030-91eb-e063-6394a90a4db02026-01-04WarningsExact identifier
application number: M017
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inc4a543f90-d43c-4487-b27e-f43394c6320d2026-01-04WarningsExact identifier
application number: M017
Doctor Hoys Pain Relief GelMENTHOL, CAMPHOR (SYNTHETIC)Dynamic Blending Specialists, Inc.50123bb9-d5d8-4ba6-ab94-8ed95fe0f5a82026-01-02WarningsExact identifier
application number: M017
Doctor Hoys Pain Relief Gel Roll-OnMENTHOL, CAMPHOR (SYNTHETIC)Dynamic Blending Specialists, Inc.bf47acb2-6c90-4d5c-820b-447cac9305a42026-01-02WarningsExact identifier
application number: M017
Amino Rip Muscle Pain ReliefLIDOCAINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION2bed5764-4217-4aa3-9d90-3b5460dcffa32026-01-02WarningsExact identifier
application number: M017
Menthozen CreamMETHYL SALICYLATE, MENTHOL, CAPSAICINVillage Pharma LLC63bb0283-cfbe-4e9c-8772-73062c0c8d052026-01-01WarningsExact identifier
application number: M017
Menthozen HydrogelMENTHOL, CAPSAICINVillage Pharma LLC4c979a71-7c8f-4dff-abae-bf4cdf8f67b42026-01-01WarningsExact identifier
application number: M017
Lidozen GelLIDOCAINE HYDROCHLORIDE, MENTHOLVillage Pharma LLCffb7831f-4ca9-4d73-8303-e9cd900789822026-01-01WarningsExact identifier
application number: M017
Sting ReliefBENZOCAINE, ISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co.,Ltd.116ee6dc-9c49-2e11-e063-6394a90a44ed2026-01-01WarningsExact identifier
application number: M017
MenthozenMETHYL SALICYLATE, MENTHOL, CAPSAICINVillage Pharma LLC48b1b99e-d0ec-4e5c-b80c-c0d2d87ecb132026-01-01WarningsExact identifier
application number: M017
NUVALU ICE THERAPY MENTHOL PAIN RELIEVINGMENTHOLJC SALES5adf457e-b4d0-30c8-e063-6294a90a64b92026-01-01WarningsExact 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