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: 2027-12-31
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: 2027-12-31

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 147 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BODY ACTION PRODUCTS Endless Love for Men	BENZOCAINE	PRODUCT MAX GROUP INC	d0fa792d-dc04-4bdf-a22d-dea896beae5b	2023-11-10	Warnings	Exact identifier application number: M017
Endless Love For Men	BENZOCAINE	Body Action Products, Inc	4e89cd3a-ecad-44c3-acb3-6d0810add8c0	2023-11-10	Warnings	Exact identifier application number: M017
BODY ACTION PRODUCTS Higher Control Male Climax	BENZOCAINE	PRODUCT MAX GROUP INC	3c7fa73b-abe8-4a8d-951c-4e785d6e812c	2023-11-10	Warnings	Exact identifier application number: M017
Uber Numb	LIDOCAINE HYDROCHLORIDE	UBERScientific, LLC	65a319a6-89d2-44c9-81d5-30327f9948cb	2023-11-10	Warnings	Exact identifier application number: M017
Uber Numb	LIDOCAINE HYDROCHLORIDE	UBERScientific, LLC	768f3f0e-1add-404f-b869-00a9f35ad34a	2023-11-10	Warnings	Exact identifier application number: M017
Zcaine Fast Acting Anesthetic	LIDOCAINE	PHI, Inc	d072243f-6ba6-4ab6-8ebf-a2381fa9c2df	2023-11-09	Warnings	Exact identifier application number: M017
Plum Smooth Plumb Numb Gelee	LIDOCAINE	Universal Companies, Inc.	6be7d8e0-6cd0-4da2-926f-3dbb3db3bd8e	2023-11-09	Warnings	Exact identifier application number: M017
Sonacaine Topical Anesthetic With Menthol	LIDOCAINE	Filltech USA, LLC	ca54c6da-4bf2-4e63-ba7f-a69c4f9c431a	2023-11-09	Warnings	Exact identifier application number: M017
Bed Bug Instant Bite Relief	LIDOCAINE	P.F. Harris Mfg. Co. LLC	7f472fd0-5605-4cc6-b4b2-1267e815255c	2023-11-09	Warnings	Exact identifier application number: M017
Valtrum Aerobic Sports	SALICYLIC ACID MENTHOL CAMPHOR (NATURAL)	LABORATORIOS QUANTIUM LLC	33f2491e-c1f2-4e5a-acbe-8ace844b88d6	2023-11-09	Warnings	Exact identifier application number: M017
Valtrum Topical Analgesic Roll On	SALICYLIC ACID MENTHOL CAMPHOR (NATURAL)	LABORATORIOS QUANTIUM LLC	28167e2a-9afb-44e7-90c7-9577df9504b6	2023-11-09	Warnings	Exact identifier application number: M017
Satohap Cool Type	CAMPHOR, MENTHOL, METHYL SALICYLATE	Sato Pharmaceutical Co., Ltd.	fe07a00a-2699-44d3-887d-bd068948ad7b	2023-11-07	Warnings	Exact identifier application number: M017
Hims Delay Wipes	BENZOCAINE WIPES	Hims Inc.	adbead3d-dca0-4919-b688-44c88f779e5a	2023-11-07	Warnings	Exact identifier application number: M017
Bakers Best Maximum Strength Pain Relief	LIDOCAINE HYDROCHLORIDE, MENTHOL	Baker's Best Health Products, LLC	9d160ff1-9c23-4a5d-82b3-82c2e1e7d34d	2023-11-06	Warnings	Exact identifier application number: M017
BAKERS BEST Pain Relief with Pure Hemp Seed Oil	LIDOCAINE HYDROCHLORIDE, MENTHOL	BAKER'S BEST HEALTH PRODUCTS, INC.	ae54c234-bfe4-4a74-b293-db7efda7884b	2023-11-06	Warnings	Exact identifier application number: M017
Arth RX Topical Analgesic	METHYL NICOTINATE, CAPSAICIN	HCD Sales	a7b3b9b4-b1c4-4e51-8e3a-c84f64c75609	2023-11-06	Warnings	Exact identifier application number: M017
BAKERS BEST Arthritis Pain Relief Cream with Hemp and Lavender	HISTAMINE DIHYDROCHLORIDE	BAKER'S BEST HEALTH PRODUCTS, INC.	03ec87c5-6669-4afb-8d9c-c8dc9907495d	2023-11-06	Warnings	Exact identifier application number: M017
DOCTORS TOUCH Erase The Pain	MENTHOL	DOCTOR'S CHOICE MEDICAL, LLC	fe9ce2c7-d6af-4dad-b6e6-5049a9e091b0	2023-11-06	Warnings	Exact identifier application number: M017
RadiaGuard Advanced Radiation Relief	LIDOCAINE HYDROCHLORIDE	SMOOTH SIDE, INC	21205087-5a2e-41a5-be40-30cba2895408	2023-11-06	Warnings	Exact identifier application number: M017
BLUE SPRING Foot and Leg Comfort	MENTHOL	ACA MANAGEMENT LLC	5f52218d-eea4-4640-b820-84c077ab98ba	2023-11-06	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