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 56 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
T-Relief Lidocaine HCL 4%	LIDOCAINE HCL 4%	Medinatura New Mexico Inc.	3c19aff8-fb18-78d0-e063-6294a90a9481	2025-12-11	Warnings	Exact identifier application number: M017
Jointiva	TROLAMINE SALICYLATE 10%	Rising Pharma Holdings, Inc.	3ee33cbf-7c0f-4982-b0b6-eeeb0202803b	2025-12-11	Warnings	Exact identifier application number: M017
LMX4	LIDOCAINE	Ferndale Laboratories, Inc.	f0e7c92f-8b0b-4045-b659-af9f6e81260f	2025-12-10	Warnings	Exact identifier application number: M017
HurriCaine One	TOPICAL ANESTHETIC AND ANTISEPTIC	Beutlich Pharmaceuticals LLC	459cedbd-9b6f-e450-e063-6394a90afb73	2025-12-10	Warnings	Exact identifier application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3	NICOTINE TRANSDERMAL PATCHES	PCHEERY LLC	45811e83-8d0b-bc2a-e063-6294a90adf50	2025-12-09	Warnings	Exact identifier application number: M017
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 2	NICOTINE TRANSDERMAL PATCHES	PCHEERY LLC	4580d7f0-92a9-d0d0-e063-6394a90ac393	2025-12-09	Warnings	Exact identifier application number: M017
LidoGuard	LIDOCAINE HCL	ALAINA HEALTHCARE PRIVATE LIMITED	c339dffe-bc9b-4fae-a50f-8db463d244c1	2025-12-09	Warnings	Exact identifier application number: M017
Capsaicin Cream 0.075%	CAPSAICIN	ALAINA HEALTHCARE PRIVATE LIMITED	33e861bd-bb92-4aea-9d4d-1b8847c794fd	2025-12-09	Warnings	Exact identifier application number: M017
Methyl Salicylate	METHYL SALICYLATE	ALAINA HEALTHCARE PRIVATE LIMITED	e07c5ebc-5497-4c45-acc5-d12e72e98f3f	2025-12-09	Warnings	Exact identifier application number: M017
Ultra Strength Pain Relief Balm	CAMPHOR, MENTHOL	ALAINA HEALTHCARE PRIVATE LIMITED	80779d1f-0c2a-4ae5-9ed7-eb6877f734ba	2025-12-09	Warnings	Exact identifier application number: M017
Pain Relief Balm	MENTHOL AND CAMPHOR	ALAINA HEALTHCARE PRIVATE LIMITED	12d76b8f-4b1d-4f2d-9722-0adb55093cc4	2025-12-09	Warnings	Exact identifier application number: M017
Trojan Extended Pleasure	BENZOCAINE	Church & Dwight Co., Inc.	be731682-4174-649a-e053-2a95a90a3987	2025-12-09	Warnings	Exact identifier application number: M017
Stopain Clinical Continuous	MENTHOL	Troy Manufacturing, Inc.	65f8d212-0f0e-4893-b6af-bd68bba46443	2025-12-09	Warnings	Exact identifier application number: M017
Pain and Itch Relief 4% Lidocaine	LIDOCAINE	Walgreens	f84e76a9-6af6-4fd1-be4e-efa05728cbfd	2025-12-09	Warnings	Exact identifier application number: M017
Capsimide	CAPSAICIN 0.025% TOPICAL PATCH	Sola Pharmaceuticals	e81c2de8-6429-d681-e053-2995a90a36a9	2025-12-08	Warnings	Exact identifier application number: M017
Extra Strength Cold-Hot Medicated Patches	MENTHOL	Cardinal Health, 110 dba LEADER	a2895c03-747c-4220-8052-4f0428062622	2025-12-08	Warnings	Exact identifier application number: M017
Leader PAIN RELIEF PATCHES	LIDOCAINE	Cardinal Health, 110 dba LEADER	5feae39e-3ab8-4cda-b9e8-dc221aea2417	2025-12-08	Warnings	Exact identifier application number: M017
Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Cardinal Health, 110 dba LEADER	f8837b69-8d85-448c-a4b4-be911bca1f6c	2025-12-08	Warnings	Exact identifier application number: M017
CAPSAICIN HOT PATCHES	CAPSAICIN	Cardinal Health, 110 dba LEADER	76e6bc39-643c-4264-8d98-0e4fa7d778e2	2025-12-08	Warnings	Exact identifier application number: M017
Leader PAIN RELIEF PATCHES	LIDOCAINE	Cardinal Health, 110 dba LEADER	3be6defd-f429-4dc7-8b37-5910705c0b81	2025-12-08	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