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 23 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kevo-ProphenJUNIPER TARFaeve, LLC4fe773a8-77cd-831e-e063-6294a90ae2ca2026-04-20WarningsExact identifier
application number: M017
BeeVenomMETHYL SALICYLATEMenper Distributors, Inc.4fe7a986-336d-ad4e-e063-6294a90a0b8a2026-04-20WarningsExact identifier
application number: M017
BenzodentBENZOCAINEFocus Consumer Healthcare, LLC5fdcb871-d387-6352-e053-2991aa0a09da2026-04-20WarningsExact identifier
application number: M017
Tecnu CalagelDIPHENHYDRAMINE HYDROCHLORIDETec Laboratories Inc.8bc9cbfe-1dd4-18ed-e053-2a95a90a79662026-04-20WarningsExact identifier
application number: M017
Aemerry Numbing CreamMENTHOL 5%Da Capo Prima LLC4fefddaf-19c8-86b4-e063-6294a90abffc2026-04-20WarningsExact identifier
application number: M017
Sting Relief SwabBENZOCAINE4 Visions LLC4fc7a356-2f1d-85af-e063-6394a90aec6b2026-04-18WarningsExact identifier
application number: M017
Equate Lidocaine and Menthol Paraben FreeLIDOCAINE 4% PLUS MENTHOL 1%Walmart Stores Inc4fa917de-bc46-0b8d-e063-6294a90a218a2026-04-17WarningsExact identifier
application number: M017
LidoProLIDOCAINE AND MENTHOLAdvanced Rx of Tennessee, LLC4faa515f-6040-d948-e063-6294a90a187f2026-04-17WarningsExact identifier
application number: M017
Coleman Bite and Sting ReliefEXTERNAL ANESTHETIC AND FIRST AID ANTISEPTICWisconsin Pharmacal Company4fadf1f1-478a-5104-e063-6294a90a10cb2026-04-17WarningsExact identifier
application number: M017
Ice Gel ICE COLD ANALGESICMENTHOLUniversal Distribution Center LLC4f921ced-7722-cba5-e063-6294a90a650b2026-04-16WarningsExact identifier
application number: M017
Walgreens Capsaicin Hot PatchCAPSAICINWalgreen Co.41e959d8-f6ac-f5b4-e063-6294a90abd962026-04-16WarningsExact identifier
application number: M017
Walgreens Cold Therapy Pain Relieving PatchMENTHOLWalgreen Co.41e7574a-348f-8eb8-e063-6294a90a6e902026-04-16WarningsExact identifier
application number: M017
Coleman Sting and Bite ReliefEXTERNAL ANALGESIC AND FIRST AID ANTISEPTICWisconsin Pharmacal Company4f94ab35-3099-716c-e063-6294a90a8bea2026-04-16WarningsExact identifier
application number: M017
Kroger Witch HazelWITCH HAZELKroger Co.461407d0-fbf6-47e9-e063-6394a90a9a832026-04-16WarningsExact identifier
application number: M017
Stopain Extra Strength GelMENTHOLTroy Manufacturing, Inc.86fe4e8c-5279-445a-a19a-e694eac785fd2026-04-16WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOL, UNSPECIFIED FORMTroy Manufacturing, Inc.4503208f-2808-4727-8066-c431230bd70b2026-04-16WarningsExact identifier
application number: M017
EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ONMENTHOLTROY MANUFACTURING, INC895896dc-0762-40a7-8313-cca10ce689842026-04-16WarningsExact identifier
application number: M017
HealthWise Medicated Cold Hot 5%MENTHOLVeridian Healthcare4f9b1b2d-1acc-e0a7-e063-6394a90aadbc2026-04-16WarningsExact identifier
application number: M017
Lidoease 2%LIDOCAINE HCL 2%PureTek Corporation3ba0c0ff-0f7a-7a29-e063-6294a90a547a2026-04-16WarningsExact identifier
application number: M017
Walgreens Lidocaine Pain Relieving Patch AssortedLIDOCAINEWalgreen Co.41e98f15-669f-4543-e063-6294a90a1ef72026-04-15WarningsExact 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