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 75 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coralite Capsaicin Heat Patch 2ctCAPSAICINUnited Exchange Corp.4128b1ac-f540-2611-e063-6294a90ac98b2025-10-08WarningsExact identifier
application number: M017
Ombre Men overtime wipesBENZOCAINESambria Pharmaceuticals, LLC405f23ca-99c1-4db4-aba1-2fd7f93f55ee2025-10-07WarningsExact identifier
application number: M017
Pain free IVLIDOCAINESambria Pharmaceuticals, LLC7aa4cb20-d452-417f-afdb-307df754ed752025-10-07WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONECVS PHARMACY, INCb3bdff5e-37fe-442a-a370-7b19799ea7812025-10-07WarningsExact identifier
application number: M017
HealthWise Pain Relief PatchMENTHOL, METHYL SALICYLATEVeridian Healthcareb65932fd-ee9f-4fa2-b842-01e0f54133c92025-10-07WarningsExact identifier
application number: M017
AREX SINSIN PASCAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDESinsin Pharmaceutical Co., Ltd.2013ea44-e2ea-4b36-bddb-7f64163284b62025-10-07WarningsExact identifier
application number: M017
SINSINPAS LIDOCAINE PAIN RELIEVINGLIDOCAINESinsin Pharmaceutical Co., Ltd.82c0a036-8750-5b3d-e053-2a91aa0a18152025-10-07WarningsExact identifier
application number: M017
SINSIN MULPASL-MENTHOL, METHYL SALICYLATE, DL-CAMPHOR, CHLORPHENIRAMINE MALEATE, THYMOLSinsin Pharmaceutical Co., Ltd.81baffcb-c08e-4616-e053-2a91aa0aaf152025-10-07WarningsExact identifier
application number: M017
Arex Sinsin PasCAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDESinsin Pharmaceutical Co., Ltd.a851854a-5dfe-4bd5-95f6-67c3f13f11872025-10-07WarningsExact identifier
application number: M017
Sinsinpas Arex Flex Gel Pain Relieving PatchL-MENTHOLSinsin Pharmaceutical Co., Ltd.1758ef9b-4fac-4066-e063-6394a90a8cc32025-10-07WarningsExact identifier
application number: M017
SINSINPAS CORN REMOVERSALICYLIC ACIDSinsin Pharmaceutical Co., Ltd.e2771dfc-ee57-553f-e053-2a95a90af2812025-10-07WarningsExact identifier
application number: M017
Feminine Anti-Itch CremeBENZOCAINE, RESORCINOLQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)aa6cc963-dc60-5222-e053-2995a90acaf62025-10-06WarningsExact identifier
application number: M017
TheraCare 2% Diphenhydramine Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEVeridian Healthcare5999b677-63dd-49c6-b5b8-7b3c117ecc5c2025-10-06WarningsExact identifier
application number: M017
HealthWise Pain ReliefMENTHOLVeridian Healthcare06be5331-7a1e-4ab3-9f17-2d350bd4b8902025-10-02WarningsExact identifier
application number: M017
equate Burn ReliefLIDOCAINE HYDROCHLORIDEWalmart Inca90cbd92-80a5-4463-8152-b83165121a6f2025-10-02WarningsExact identifier
application number: M017
AsperFlex HOTCAMPHOR, MENTHOL, METHYL SALICYLATEAkron Pharma Inc.a6cb0656-8866-44ff-b40c-73655ff687212025-10-02WarningsExact identifier
application number: M017
AsperFlex Original Maximum StrengthMENTHOLAkron Pharma Inc.d766c61e-c48b-4aff-97b0-678159479e032025-10-02WarningsExact identifier
application number: M017
HealthWise Feminine Anti-Itch CreamBENZOCAINE, RESORCINOLVeridian Healthcare1f9110da-f448-8e20-e063-6294a90a42752025-10-02WarningsExact identifier
application number: M017
PROSTAT FIRST AID Burn Ease, 0.9gLIDOCAINEProStat First Aid LLCdc704403-e2aa-47f7-a7f4-f6afe1547ca82025-10-01WarningsExact identifier
application number: M017
PROSTAT FIRST AID Burn Ease, 0.9gLIDOCAINEProStat First Aid LLCe02558a9-fe2b-4f28-9fd3-7308f859d7592025-10-01WarningsExact 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