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 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: 2026-12-31

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
08819ad0-97c2-49bd-b923-535b94a27167	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-07-28	La Flecha Japonesa
2022-02-18	La Flecha Japonesa
2022-01-28	La Flecha Japonesa
2020-02-27	La Flecha Japonesa
2020-01-31	La Flecha Japonesa

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
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 75 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kalaya Extra Strength Pain Relief Cream with Hemp Seed Oil	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	2eccf23c-fae2-423c-9cae-549bc4194104	2025-10-08	Warnings	Exact identifier application number: M017
KALAYA BACK AND NECK PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAMPHOR	Avaria Health & Beauty Corp	48fd73e7-1443-4ac7-bf7c-d99bf2449f51	2025-10-08	Warnings	Exact identifier application number: M017
Lidocaine Pain Relieving Patch	LIDOCAINE 4%	BluePoint Laboratories	3117273d-e006-2726-e063-6294a90a9c33	2025-10-08	Warnings	Exact identifier application number: M017
EQUATE PAIN RELIEVING PATCHES	LIDOCAINE 4%	WALMART, INC	01e1cc0e-e1c9-d274-e063-6294a90a409e	2025-10-08	Warnings	Exact identifier application number: M017
Equate Pain Relief Balm	MENTHOL 11%, CAMPHOR 11% OINTMENT	WALMART, INC	d8ddf835-f008-ce1f-e053-2a95a90aa9b3	2025-10-08	Warnings	Exact identifier application number: M017
TheraCare Pain Relieving Menthol Gel	MENTHOL 2%	Veridian Healthcare	9d2ccb02-746c-4cb9-905d-280987778f4d	2025-10-08	Warnings	Exact identifier application number: M017
COOLING PAIN RELIEF	MENTHOL, CAMPHOR	SUNSET NOVELTIES, INC	3a9019b1-8798-1ef9-e063-6394a90a09a4	2025-10-08	Warnings	Exact identifier application number: M017
Coralite Capsaicin Heat Patch 2ct	CAPSAICIN	United Exchange Corp.	4128b1ac-f540-2611-e063-6294a90ac98b	2025-10-08	Warnings	Exact identifier application number: M017
Ombre Men overtime wipes	BENZOCAINE	Sambria Pharmaceuticals, LLC	405f23ca-99c1-4db4-aba1-2fd7f93f55ee	2025-10-07	Warnings	Exact identifier application number: M017
Pain free IV	LIDOCAINE	Sambria Pharmaceuticals, LLC	7aa4cb20-d452-417f-afdb-307df754ed75	2025-10-07	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	CVS PHARMACY, INC	b3bdff5e-37fe-442a-a370-7b19799ea781	2025-10-07	Warnings	Exact identifier application number: M017
HealthWise Pain Relief Patch	MENTHOL, METHYL SALICYLATE	Veridian Healthcare	b65932fd-ee9f-4fa2-b842-01e0f54133c9	2025-10-07	Warnings	Exact identifier application number: M017
AREX SINSIN PAS	CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE	Sinsin Pharmaceutical Co., Ltd.	2013ea44-e2ea-4b36-bddb-7f64163284b6	2025-10-07	Warnings	Exact identifier application number: M017
SINSINPAS LIDOCAINE PAIN RELIEVING	LIDOCAINE	Sinsin Pharmaceutical Co., Ltd.	82c0a036-8750-5b3d-e053-2a91aa0a1815	2025-10-07	Warnings	Exact identifier application number: M017
SINSIN MULPAS	L-MENTHOL, METHYL SALICYLATE, DL-CAMPHOR, CHLORPHENIRAMINE MALEATE, THYMOL	Sinsin Pharmaceutical Co., Ltd.	81baffcb-c08e-4616-e053-2a91aa0aaf15	2025-10-07	Warnings	Exact identifier application number: M017
Arex Sinsin Pas	CAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDE	Sinsin Pharmaceutical Co., Ltd.	a851854a-5dfe-4bd5-95f6-67c3f13f1187	2025-10-07	Warnings	Exact identifier application number: M017
Sinsinpas Arex Flex Gel Pain Relieving Patch	L-MENTHOL	Sinsin Pharmaceutical Co., Ltd.	1758ef9b-4fac-4066-e063-6394a90a8cc3	2025-10-07	Warnings	Exact identifier application number: M017
SINSINPAS CORN REMOVER	SALICYLIC ACID	Sinsin Pharmaceutical Co., Ltd.	e2771dfc-ee57-553f-e053-2a95a90af281	2025-10-07	Warnings	Exact identifier application number: M017
Capsaicin	CAPSAICIN	PHARMACURE LLC	05a09ee5-e7a4-4758-8b16-f60b945a7d82	2025-10-06	Warnings	Exact identifier application number: M017
Lidocanna	LIDOCAINE	PHARMACURE LLC	b28ebbb6-1112-4750-a2bb-f96b03fabe6e	2025-10-06	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2719838	methyl salicylate 10.5 % Topical Oil	PSN	08819ad0-97c2-49bd-b923-535b94a27167	5
2719838	methyl salicylate 105 MG/ML Topical Oil	SCD	08819ad0-97c2-49bd-b923-535b94a27167	5
2719838	methyl salicylate 10.5 % Topical Oil	SY	08819ad0-97c2-49bd-b923-535b94a27167	5

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