Home NDC 53145-047 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 2027-12-31
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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 53145-047 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53145-047 53145-047-01 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYL SALICYLATE 105 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LAV5U5022Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2719838 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53145-047-01 La Flecha Japonesa 1 in 1 CARTON OIL 1 5 53145-047-01 La Flecha Japonesa 15 mL in 1 BOTTLE, GLASS OIL 15 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHYL SALICYLATE ACTIVE INGREDIENT LAV5U5022Y LA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.] 1 SALICYLIC ACID ACTIVE MOIETY O414PZ4LPZ LA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.] 1 CAJUPUT OIL INACTIVE INGREDIENT J3TO6BUQ37 LA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.] 1 CLOVE OIL INACTIVE INGREDIENT 578389D6D0 LA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.] 1 EUCALYPTUS OIL INACTIVE INGREDIENT 2R04ONI662 LA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.] 1 JUNIPER BERRY OIL INACTIVE INGREDIENT SZH16H44UY LA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.] 1 MENTHOL INACTIVE INGREDIENT L7T10EIP3A LA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP LA FLECHA JAPONESA (METHYL SALICYLATE) OIL [MENPER DISTRIBUTORS, INC.] 1 PEPPERMINT OIL INACTIVE INGREDIENT AV092KU4JH LA 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 114 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TheraCare Maximum Strength Pain Relief Patch LIDOCAINE Veridian Healthcare dfaf8a77-2276-4791-e053-2a95a90a3288 2024-12-10 Warnings Exact identifier application number: M017 Methyl Salicylate METHYL SALICYLATE Alexso, Inc eef555d3-f23d-4847-93f3-fa7a06072a0f 2024-12-09 Warnings Exact identifier application number: M017 Lidocaine 4 Percent LIDOCAINE SA3, LLC 651710db-3c50-4bcf-b7cc-9ed24f663427 2024-12-09 Warnings Exact identifier application number: M017 HealthWise Pain Relief Lidocaine Patch LIDOCAINE 4% Veridian Healthcare 28db1c03-d01f-83ea-e063-6294a90aee26 2024-12-09 Warnings Exact identifier application number: M017 Joint and Muscle Pain Relief MENTHOL Allure Labs e82f99fd-c2ef-686f-e053-2a95a90a1dc9 2024-12-09 Warnings Exact identifier application number: M017 Tough Love Pain Relieving LIDOCAINE HCL Allure Labs ee8c1a2b-36ef-6fd7-e053-2a95a90a9c01 2024-12-09 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN SA3, LLC 5617e91d-e650-4a0d-8565-b8288ea41c77 2024-12-09 Warnings Exact identifier application number: M017 Medicaine Sting and Bite BENZOCAINE James Alexander Corporation 753e6cbe-31e0-4017-93d0-8b4bf5972f37 2024-12-09 Warnings Exact identifier application number: M017 AUVON Pain Relief Roll-on MENTHOL SHENZHEN YUWEN E-COMMERCE CO., LTD. df239c4d-af6a-41ca-baed-d0788782ce9f 2024-12-08 Warnings Exact identifier application number: M017 AUVON Pain Relief Roll-on LIDOCAINE SHENZHEN YUWEN E-COMMERCE CO., LTD. 8b30f623-6077-4f2e-8fa4-ce4a298953b5 2024-12-08 Warnings Exact identifier application number: M017 QC Medicated anti itch PRAMOXINE HYDROCHLORIDE, MENTHOL Chain Drug Marketing Association b5e41e3a-81df-3a63-e053-2a95a90a5839 2024-12-08 Warnings Exact identifier application number: M017 QC Lidocaine Maximum Strength LIDOCAINE HCL Chain Drug Marketing Association b5e1b1ab-8a95-2d2d-e053-2995a90aea53 2024-12-08 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN Alexso, Inc 433da27d-04fb-481a-bbb0-874bb72c806a 2024-12-06 Warnings Exact identifier application number: M017 POMG PAIN RELIEF BODY LIDOCAINE POMG LLC 28d7ac46-b27f-43bb-e063-6294a90a93ed 2024-12-06 Warnings Exact identifier application number: M017 Capsaicin 0.1 Percent CAPSAICIN Alexso, Inc 0090ca38-6433-45c4-9453-edf2788c14c6 2024-12-06 Warnings Exact identifier application number: M017 Signature Care Menthol MENTHOL 4% Safeway 27d3cb47-a6c7-5b7a-e063-6394a90a056f 2024-12-05 Warnings Exact identifier application number: M017 ITCH X BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE BF ASCHER AND CO INC 03c16d33-8f59-0184-e054-00144ff8d46c 2024-12-05 Warnings Exact identifier application number: M017 PO First Aid Series BURN LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. f1c349a8-216d-4233-922e-c95329a33d1e 2024-12-05 Warnings Exact identifier application number: M017 Post Treatment Balm HYDROCORTISONE Allure Labs Inc. faa803e6-453c-4d86-85dd-5a5dcdd72d02 2024-12-05 Warnings Exact identifier application number: M017 CBD Pain Relief Cream TROLAMINE SALICYLATE Allure Labs b6b3102a-4154-2da2-e053-2995a90ae99f 2024-12-05 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 53145-047-01 53145004701 1 BOTTLE, GLASS in 1 CARTON (53145-047-01) / 15 mL in 1 BOTTLE, GLASS 2012-02-21 0000-00-00 No No Current