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 61 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nighttime 4X Medicated Cream	BENZOCAINE	Rite Aid	21645ed1-2dc0-223a-e063-6394a90ab021	2025-11-21	Warnings	Exact identifier application number: M017
4x Medicated Gum Cream	BENZOCAINE	Albertsons	b81a308c-9c30-0e3d-e053-2a95a90a15d2	2025-11-21	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET NOVELTIES, INC	b0edd9d9-951f-d3dd-e053-2995a90a8d5a	2025-11-21	Warnings	Exact identifier application number: M017
Up up	LIDOCAINE PAIN RELIEF MAXIMUM STRENGTH PATCHES	Target Corporation	44121d40-86e1-0df6-e063-6294a90aedaf	2025-11-20	Warnings	Exact identifier application number: M017
Up up	PAIN RELIEF ADVANCED HYDROGEL PATCHES	Target Corporation	44128b70-3172-ee37-e063-6294a90a705f	2025-11-20	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET NOVELTIES, INC	f03090fa-f7e6-f53a-e053-2a95a90aa819	2025-11-20	Warnings	Exact identifier application number: M017
HEATING PAIN RELIEF	METHYL SALICYLATE, MENTHOL	SUNSET NOVELTIES, INC	ff073e47-3107-e17e-e053-6294a90a58fa	2025-11-20	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET NOVELTIES, INC	fc8a8f20-97ab-481e-e053-6394a90a3525	2025-11-20	Warnings	Exact identifier application number: M017
MENTHOL	MENTHOL	SUNSET PAIN RELIEF ROLL-ON 3OZ	934d4638-b47b-187d-e053-2995a90ae69d	2025-11-20	Warnings	Exact identifier application number: M017
FOOT PAIN RELIEF ROLL-ON	LIDOCAINE, MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	43edcea0-ab04-f368-e063-6294a90a817a	2025-11-19	Warnings	Exact identifier application number: M017
Absolut Skin Corticosoothe Anti-Itch	HYDROCORTISONE	Absolut Skin Incorporated	deb52218-9176-4aaa-a22f-b66dada6690f	2025-11-19	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch Good Neighbor Pharmacy	LIDOCAINE	InterMed Laboratories Private Limited	43f3d189-f6b7-02ed-e063-6394a90afd73	2025-11-19	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch HealthA2Z	LIDOCAINE	InterMed Laboratories Private Limited	43f3e288-e828-8130-e063-6394a90a6d44	2025-11-19	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch Leader	LIDOCAINE	InterMed Laboratories Private Limited	42f06914-c8b8-ea9c-e063-6294a90a79e6	2025-11-19	Warnings	Exact identifier application number: M017
CVS Anti-Itch	CAMPHOR, MENTHOL	CVS	87715662-c788-9a8d-e053-2a95a90acb53	2025-11-19	Warnings	Exact identifier application number: M017
Walgreen Anti Itch	CAMPHOR, MENTHOL	Walgreens	b4f47a8d-d4a6-9233-e053-2a95a90afd90	2025-11-19	Warnings	Exact identifier application number: M017
Leader Anti-Itch	CAMPHOR, MENTHOL	LEADER/Cardinal Helath 110, Inc.	9ca985c6-5017-0558-e053-2995a90a8202	2025-11-19	Warnings	Exact identifier application number: M017
CVS Anti-Itch	PRAMOXINE HCL	CVS	87fc476a-5b12-7383-e053-2995a90a530b	2025-11-19	Warnings	Exact identifier application number: M017
Walgreen Anti-Itch	PRAMOXINE HCL	Walgreens	b5f9d1c5-891e-4377-e053-2995a90aa281	2025-11-19	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET PAIN RELIEF	89f5f688-856f-f2df-e053-2995a90a73cf	2025-11-19	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