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#

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 49 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trauma LessMENTHOLNatures Formulae Health Products Ltd.781e94d5-1d34-7202-e053-2991aa0ae7682025-12-29WarningsExact identifier
application number: M017
Quality Choice Cold Therapy GelMENTHOLChain Drug Marketing Association, Inc.f9c659cd-e7fa-ac2d-e053-6294a90a25732025-12-29WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINEHarris Teeter5a0501e8-bc06-4e33-8db8-93b21a7151412025-12-29WarningsExact identifier
application number: M017
Hot and Cold Medicated PatchMENTHOLHarris Teeter9debd4ef-c21b-41ae-afd1-58f47c51c99c2025-12-29WarningsExact identifier
application number: M017
Maximum OTC Strength Feminine Anti-Itch CremeBENZOCAINE, RESORCINOLQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)0e9a711c-ddf4-af63-e063-6294a90a0ebe2025-12-29WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEHarris Teeter3f5b4eee-49c4-408c-9af2-e7924c26ac632025-12-29WarningsExact identifier
application number: M017
talc-free medicated bodyMENTHOLDavion, Inc27b9b4dc-4d4f-4e9d-b388-a7c6807a0e9b2025-12-29WarningsExact identifier
application number: M017
H-E-B Medicated Corn Starch Foot PowderMENTHOLDavion, Inca6675e00-bc6b-4466-a283-4cece5f919702025-12-29WarningsExact identifier
application number: M017
Maximum Strength Medicated Foot PowderMENTHOLDavion, Inc7b442d99-ac19-4f65-828d-954c5350ef5a2025-12-29WarningsExact identifier
application number: M017
HEB Medicated Cornstarch Body PowderMENTHOLDavion, Incdf1331fb-48df-4f21-8564-0468078fd12d2025-12-29WarningsExact identifier
application number: M017
Honest Med Capsaicin PatchCAPSAICINProper Buys LLC30169d44-b1b2-5c0f-e063-6294a90ae1592025-12-28WarningsExact identifier
application number: M017
Honest Med Lidocaine Lavender Roll-onLIDOCAINE HCLProper Buys LLC2dcd40a9-3fdd-a71e-e063-6294a90a704f2025-12-28WarningsExact identifier
application number: M017
Honest Med Lidocaine Pain Relief PatchLIDOCAINEProper Buys LLC13a5243f-7116-e4da-e063-6394a90aa5432025-12-28WarningsExact identifier
application number: M017
CVS Health Pain-Relieving PatchMENTHOL, METHYL SALICYLATE, CAMPHORCVS Pharmacy, Inc.1f90899c-eeca-2362-e063-6294a90aa0da2025-12-28WarningsExact identifier
application number: M017
CVS Health Cooling PatchMENTHOLCVS Pharmacy, Inc1f90cefe-bcce-5e17-e063-6294a90a57362025-12-28WarningsExact identifier
application number: M017
Point Relief LidoSpot with MentholLIDOCAINE, MENTHOLFabrication Enterprisesf0c69693-bfea-4006-9620-63b222d25d382025-12-28WarningsExact identifier
application number: M017
DISCOUNT DRUG MART PAIN RELIEF PATCHESLIDOCAINEDiscount Drug Mart, Ince36e7d0a-d554-4601-b535-b41ee84a6b242025-12-28WarningsExact identifier
application number: M017
Medicated Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEDiscount Drug Mart, Incc01e1a14-bfbc-4c52-8a67-b77acf2d88532025-12-28WarningsExact identifier
application number: M017
TopCare Pain Relief PatchLIDOCAINE, MENTHOLTopco Associates LLCd4c89c4f-d69a-7786-e053-2995a90a71e72025-12-28WarningsExact identifier
application number: M017
Kroger Lidocaine Pain RelievingLIDOCAINE HCLKroger Company12d94ba6-56ac-3816-e063-6394a90a44c62025-12-28WarningsExact 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