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 113 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HealthWise Medicated Foot Powder MENTHOL Veridian Healthcare 2916a0c3-2d66-d079-e063-6394a90acd6b 2024-12-12 Warnings Exact identifier application number: M017 Ease Your Pain MENTHOL Proximity Capital Partners LLC dba Asutra 83366ae1-e1d9-2a30-e053-2a91aa0a1cc4 2024-12-12 Warnings Exact identifier application number: M017 Natural Seal Itch Relief for Kids LIDOCAINE Kericure Inc. 31cc0c95-5864-4737-b085-8f58e00f4f05 2024-12-12 Warnings Exact identifier application number: M017 Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula HYDROCORTISONE ACETATE Combe Incorporated 9b69fa24-02dd-43e4-a81f-9a37968d7099 2024-12-12 Warnings Exact identifier application number: M017 VAGISIL Anti-Itch Medicated Creme Maximum Strength BENZOCAINE AND RESORCINOL Combe Incorporated bb73ebd7-ceb0-4b54-9e8f-77486d9037fb 2024-12-12 Warnings Exact identifier application number: M017 VAGISIL Anti-Itch Creme Regular Strength BENZOCAINE AND RESORCINOL Combe Incorporated dd303ff8-0deb-4292-bfd8-5bda91f86d51 2024-12-12 Warnings Exact identifier application number: M017 VAGISIL Anti-Itch Medicated Wipes Maximum Strength PRAMOXINE HYDROCHLORIDE Combe Incorporated b848f53d-8aea-4efe-aa2c-009d5121fc33 2024-12-12 Warnings Exact identifier application number: M017 Walgreens Cool and Heat MENTHOL 16% Walgreens ce1585f4-ca65-8d0c-e053-2995a90a8e89 2024-12-11 Warnings Exact identifier application number: M017 Walgreens Cool n Heat LIDOCAINE 4% Walgreens ce1b21d6-7aa6-2b18-e053-2995a90a4c91 2024-12-11 Warnings Exact identifier application number: M017 Walgreens Pain Burn Itch Relief BENZOCAINE 20%, MENTHOL 0.5% Walgreens cc6e4b42-fdd8-6ff7-e053-2995a90a3d1d 2024-12-11 Warnings Exact identifier application number: M017 Pramoxine Itch relief PRAMOXINE HCL 1% CVS e947694c-c122-0291-e053-2995a90ac39a 2024-12-11 Warnings Exact identifier application number: M017 Arthritis Cream TROLAMINE SALICYLATE 10% CVS d1663f50-479b-4d55-e053-2995a90a223f 2024-12-11 Warnings Exact identifier application number: M017 CVS Pain Relief MENTHOL 4% CVS d1660d55-1ee0-7aa2-e053-2995a90a6579 2024-12-11 Warnings Exact identifier application number: M017 CVS Muscle Rub MENTHOL 10%, METHYL SALICYLATE 15% CVS Health c72c9a95-4226-6d69-e053-2a95a90a8e1c 2024-12-11 Warnings Exact identifier application number: M017 BENGAY ULTRA STRENGTH NON-GREASY CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE Kenvue Brands LLC 0a41ec65-bd0b-4fc6-807d-74f353341cc7 2024-12-11 Warnings Exact identifier application number: M017 Serum X LIDOCAINE HYDROCHLORIDE AO Biologix, LLC e07b6268-6400-6849-e053-2a95a90a8b3e 2024-12-11 Warnings Exact identifier application number: M017 PlusCBD Pain Cream (Penetrating) 2oz CAMPHOR, MENTHOL CV Sciences, Inc. ca39d327-6bf3-3408-e053-2a95a90af2d5 2024-12-11 Warnings Exact identifier application number: M017 Blistex Medicated DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL Blistex Inc. e95439d3-f12b-4c1c-999a-79f2ddba4cfb 2024-12-11 Warnings Exact identifier application number: M017 Blistex Foille Medicated First Aid BENZOCAINE AND CHLOROXYLENOL Blistex Inc. e2eca808-e97b-43e0-aa51-7025cc61c7a8 2024-12-11 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE J&A Digital Inc. ff95a536-35b3-4006-b43c-cce359e86aa9 2024-12-10 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