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 112 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join QC Cool and Heat Roll-On MENTHOL 16% Chain Drug Marketing Association Inc d35e9dfa-8a28-fdb3-e053-2995a90abc52 2024-12-15 Warnings Exact identifier application number: M017 Meijer Cold and Hot Pain Relieving MENTHOL 16% Meijer bec62df3-06c9-a115-e053-2995a90a4267 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief MENTHOL 16% Tommie Copper, Inc. b4dfa5fa-2d61-db1e-e053-2a95a90a7ac8 2024-12-15 Warnings Exact identifier application number: M017 Pain Relief Liquid Roller CAMPHOR 3.5%, MENTHOL 3.5% Tommie Copper, Inc. c9f0447e-de43-16a5-e053-2995a90a05c1 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief Maximum Strength TROLAMINE SALICYLATE 10% Tommie Copper, Inc. b622c14f-9bf3-0bbd-e053-2a95a90a2adc 2024-12-15 Warnings Exact identifier application number: M017 Copperlife Pain Relief TROLAMINE SALICYLATE 10% Tommie Copper, Inc. c94d00f9-42ce-1d43-e053-2a95a90a058d 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief Roller CAMPHOR 3.5%, MENTHOL 3.5% Tommie Copper, Inc. b6c3d6eb-b485-33b8-e053-2a95a90a41e1 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief Roller CAMPHOR 3.5%, MENTHOL 3.5% Tommie Copper, Inc. b4cd4fed-e8c8-db85-e053-2995a90a708b 2024-12-15 Warnings Exact identifier application number: M017 Copperlife Pain Relief Liquid MENTHOL 16% Tommie Copper, Inc. c93a0139-953b-5523-e053-2a95a90a0b2d 2024-12-15 Warnings Exact identifier application number: M017 Tommie Copper Pain Relief TROLAMINE SALICYLATE 10% Tommie Copper, Inc. ca011b03-a263-1908-e053-2995a90ad970 2024-12-15 Warnings Exact identifier application number: M017 Warrior Chiggerex Relief BENZOCAINE 10% Derma Care Research Labs, LLC dcf2f52b-2295-58e5-e053-2995a90a7fd8 2024-12-15 Warnings Exact identifier application number: M017 Capsaicin Cream CAPSAICIN Trifecta Pharmaceuticals USA LLC def8d341-06a7-0e9b-e053-2995a90a0ad6 2024-12-13 Warnings Exact identifier application number: M017 Mentholatum Original CAMPHOR, MENTHOL The Mentholatum Company 19e4b812-67c6-49fd-833a-b432100363f5 2024-12-13 Warnings Exact identifier application number: M017 Cold and Hot Medicated MENTHOL The Mentholatum Company 85bf425d-59d7-4462-ba46-292145460099 2024-12-13 Warnings Exact identifier application number: M017 Mentholatum Lidocaine Ice LIDOCAINE HCL, MENTHOL The Mentholatum Company 4d74cbab-31cd-4579-9360-6852ee215b5e 2024-12-13 Warnings Exact identifier application number: M017 Mentholatum Deep Heating Rub Extra Strength MENTHOL, METHYL SALICYLATE The Mentholatum Company f5684158-0d83-4031-b493-5422ddc73e78 2024-12-13 Warnings Exact identifier application number: M017 Discount Drug Mart Anti-Itch CAMPHOR, MENTHOL Discount Drug Mart 87d379da-103a-c751-e053-2995a90a56de 2024-12-13 Warnings Exact identifier application number: M017 Audiologist Anti-itch HYDROCORTISONE OAKTREE PRODUCTS, INC. 853e078e-1e91-d55f-e053-2991aa0a6dcd 2024-12-13 Warnings Exact identifier application number: M017 CVS Anti itch HYDROCORTISONE CVS 884df604-711b-4a3d-e053-2995a90a3a04 2024-12-13 Warnings Exact identifier application number: M017 Dermoplast Pain Relieving BENZOCAINE AND LEVOMENTHOL Advantice Health, LLC 2347f0b8-d463-422d-8583-65624d9a1a91 2024-12-12 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