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 88 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tattoo TATTOO CREAM Perfso (HK) Co., Limited 39773cab-12df-4520-e063-6294a90abc5b 2025-07-08 Warnings Exact identifier application number: M017 Neutrogena Sun Rescue After Sun Medicated Relief CAMPHOR (SYNTHETIC) Kenvue Brands LLC c95c5b64-b90f-1143-e053-2a95a90aa03c 2025-07-07 Warnings Exact identifier application number: M017 sunmark Hydrocortisone HYDROCORTISONE Strategic Sourcing Services LLC 210079e9-3d2f-4489-b468-b96b145034ed 2025-07-07 Warnings Exact identifier application number: M017 Relief Gel LIDOCAINE HCL Good Clean Love, Inc. e5fa2265-ccb7-750c-e053-2995a90aa51e 2025-07-07 Warnings Exact identifier application number: M017 Hydrocortisone Plus 12 Moisturizers HYDROCORTISONE Sun Pharmaceutical Industries, Inc. 09ac2749-a60f-4039-8c80-a0d2eaf50c34 2025-07-07 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Sun Pharmaceutical Industries, Inc. 2ada9ec2-1c28-4da2-8639-07b3193ffb32 2025-07-03 Warnings Exact identifier application number: M017 Hydrocortisone with Aloe HYDROCORTISONE Sun Pharmaceutical Industries, Inc. caa2fd64-e262-4d7c-ad8a-69f506feba8c 2025-07-03 Warnings Exact identifier application number: M017 Stopain Extra Strength MENTHOL Troy Manufacturing, Inc. 07e9a235-6d10-4407-8729-beaf936e97ad 2025-07-03 Warnings Exact identifier application number: M017 Blue Ice Topical Analgesic Gel ICE GEL International Wholesale 397cd306-078d-5b7d-e063-6294a90a8bbc 2025-07-03 Warnings Exact identifier application number: M017 LIDOCAINE LIDOCAINE, MENTHOL Vive Health LLC 236ccc6d-21b7-6153-e063-6394a90a4634 2025-07-02 Warnings Exact identifier application number: M017 AsperFlex MAX LIDOCAINE 4% WITH MENTHOL 1% Akron Pharma Inc. ccf6172b-350a-4b78-b844-f84bf17c491f 2025-07-02 Warnings Exact identifier application number: M017 METHYL SALICYLATE 25% METHYL SALICYLATE Oncora Pharma, LLC 3766e3a9-94a8-4c3e-e063-6394a90aa24a 2025-07-01 Warnings Exact identifier application number: M017 Diphenhydramine Hydrochloride and Zinc Acetate DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE Sun Pharmaceutical Industries, Inc. c89e3de8-7d71-485c-8fc5-2832d6024f16 2025-07-01 Warnings Exact identifier application number: M017 Westlake Outdoor Pain and Itch Relieving LIDOCAINE 4% PAIN AND ITCH RELIEVING WESTLAKE HB PHARMA 3c563b28-4f4f-9d0c-e063-6294a90adf73 2025-07-01 Warnings Exact identifier application number: M017 Cortizone 10 Water Resistant HYDROCORTISONE Chattem, Inc. 118e55e7-241f-44c4-959e-09bf6221bd77 2025-07-01 Warnings Exact identifier application number: M017 Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 38c1616e-3b09-0669-e063-6294a90a2c86 2025-06-29 Warnings Exact identifier application number: M017 Plantar Fasciitis Cream CAMPHOR SOLALIA LLC 388f33c2-2bdf-ded8-e063-6294a90aeeac 2025-06-27 Warnings Exact identifier application number: M017 4 Lidocaine Topical Anesthetic LIDOCAINE RUGBY LABORATORIES 63327e57-f4c8-4ae6-9d28-cef8697bbdcc 2025-06-27 Warnings Exact identifier application number: M017 Diphenhydramine HCl and Zinc Acetate ANTI-ITCH CONTINUOUS SPRAY Wal-Mart Stores, Inc. 709c3bb8-5b36-4823-941a-45ddb3e431c4 2025-06-27 Warnings Exact identifier application number: M017 Burn Relief Professional Bio-Kool LIDOCAINE - 4% Kool-Down Inc. 827e9c69-4706-0ccf-e053-2991aa0aa1c1 2025-06-27 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