FDA.reportPublic FDA data

La Flecha Japonesa

Product NDC
53145-047
11-digit product format
531450047
Labeler code
53145
Product ID
53145-047_3a89cc64-eb78-0ae0-e063-6394a90a706c
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl salicylate
Dosage form
OIL
Route
TOPICAL
Labeler
Menper Distributors, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-02-21
Substance
METHYL SALICYLATE
Active strength
105 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct53145-047EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53145-04753145-047-01EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
La Flecha Japonesa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE105 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2719838Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
08819ad0-97c2-49bd-b923-535b94a27167Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-07-28La Flecha Japonesa
2022-02-18La Flecha Japonesa
2022-01-28La Flecha Japonesa
2020-02-27La Flecha Japonesa
2020-01-31La Flecha Japonesa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-047-01La Flecha Japonesa1 in 1 CARTONOIL15
53145-047-01La Flecha Japonesa15 mL in 1 BOTTLE, GLASSOIL155

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YLA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZLA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.]1
CAJUPUT OILINACTIVE INGREDIENTJ3TO6BUQ37LA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.]1
CLOVE OILINACTIVE INGREDIENT578389D6D0LA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.]1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662LA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.]1
JUNIPER BERRY OILINACTIVE INGREDIENTSZH16H44UYLA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ALA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPLA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.]1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHLA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.]1

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 66 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROCORTISONEHYDROCORTISONEEncube Ethicals, Inc.969cd576-82d3-4662-bbc1-3587a1f6a5642025-11-10WarningsExact identifier
application number: M017
Jelcaine SterileLIDOCAINE HCL JELLY USP, 2%Brookfield Pharmaceuticals, LLC1a39d1de-7aa2-3068-e063-6394a90aed852025-11-10WarningsExact identifier
application number: M017
Hush AnestheticLIDOCAINEHUSH Anestheticc6e86a0f-6f9b-45b7-86ce-0bb1c198061a2025-11-10WarningsExact identifier
application number: M017
Hush AnestheticLIDOCAINEHUSH Anesthetic97ae1993-7268-4b7f-92e2-6004337d56502025-11-10WarningsExact identifier
application number: M017
MENTHOL AND METHYL SALICYLATEELECTRIC MEDICATED BALM ULTRA STRENGTHFEI FAH MEDICAL MANUFACTURING PTE LTD91e6d3b9-25bb-4015-9d96-bd27f93e5ada2025-11-10WarningsExact identifier
application number: M017
E MEI SHAN MEDICATEDCAMPHOR, MENTHOLZhejiang Dingtai Pharmaceutical Co., Ltdbda1e7c1-42df-4126-a512-80f843b07fd02025-11-10WarningsExact identifier
application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEVINGCAMPHOR AND MENTHOLZhejiang Dingtai Pharmaceutical Co., Ltd9850754b-ac94-4ec6-b75a-8096e5ac94562025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
TONG FENG DING PAIN RELIEFCAMPHOR AND MENTHOLZhejiang Dingtai Pharmaceutical Co., Ltdfe87b864-b3ee-4a4b-8e5a-e1ee6493de0d2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Solstice Pain RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC5ef90782-8201-47d1-b57f-f032d4c9b06a2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Solstice Pain RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC1388ab3a-c26f-427d-898d-0d88411a5fba2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Solstice Capsaicin Patch HotCAPSAICINMADISON ONE ACME INCf74db6e0-853a-4eb3-a4b5-9da2cd3d95cf2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
Lung Choy Shung Pain Relief LiquidMENTHOL AND CAMPHORMADISON ONE ACME INC4842c6ec-7823-4f6b-afc4-258fce2c23912025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
701 DIEDA ZHENGTONG YAOGAO MEDICATEDCAMPHOR AND MENTHOLMADISON ONE ACME INC115041ff-5046-4ca4-b54b-5652037e74bd2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEFCAMPHOR AND MENTHOLMADISON ONE ACME INC0f269a41-4b56-4e22-b9cb-17d99bf76a572025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
ZANG HONG HUA PAIN RELIEVINGCAMPHOR, CAPSAICIN, AND METHYL SALICYLATEMADISON ONE ACME INCe0a8811c-07cf-4dee-a0e5-13b8af1b27b62025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
NECK AND LUMBAR PAIN RELIEVING BALMCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INCd06f0650-a5f6-4bc1-a70b-b0fc16968fa92025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
SHU JIN HUO LUO PAIN RELIEVINGCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INCccb6740d-3399-4a2b-ae65-15ca557ba83b2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
GuruNanda Pain ReliefLIDOCAINE HYDROCHLORIDEGuruNanda, LLC.3ab6a133-8dca-e14e-e063-6394a90a85e72025-11-10WarningsExact identifier
application number: M017
HUO LUO PAIN RELIEVINGCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC65581716-5a2c-4ee8-816d-00caed7b95b42025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
JOSEPHS LION PAIN RELIEVINGCAMPHOR, MENTHOL, METHYL SALICYLATEMADISON ONE ACME INC69b88e21-2001-4fb2-b6eb-17f2d6e0ef2e2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2719838methyl salicylate 10.5 % Topical OilPSN08819ad0-97c2-49bd-b923-535b94a271675
2719838methyl salicylate 105 MG/ML Topical OilSCD08819ad0-97c2-49bd-b923-535b94a271675
2719838methyl salicylate 10.5 % Topical OilSY08819ad0-97c2-49bd-b923-535b94a271675

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53145-047-01531450047011 BOTTLE, GLASS in 1 CARTON (53145-047-01) / 15 mL in 1 BOTTLE, GLASS2012-02-210000-00-00NoNoCurrent