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 140 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Valtrum IMMEDIATE ACTION TOPICAL ANALGESIC	CAMPHOR, MENTHOL, METHYL SALICYLATE	LABORATORIOS QUANTIUM LLC	c4efa317-8dd1-49e1-b7ca-9df2147edd3e	2023-12-21	Warnings	Exact identifier application number: M017
DDM Camphor Spirit	CAMPHOR 10%	Discount Drug Mart	5d56cbe6-4e48-79eb-e053-2a91aa0a74d3	2023-12-20	Warnings	Exact identifier application number: M017
Quality Choice Camphor Spirit	CAMPHOR 10%	Chain Drug Market Association	8d352a67-2024-43d0-b525-038d398949e6	2023-12-20	Warnings	Exact identifier application number: M017
Instant Antiseptic Pain Relief	CAMPHOR 10.8% AND PHENOL 4.7%	Chain Drug Market Association	2cd60df3-bfde-4747-ba4f-7121612f2e63	2023-12-20	Warnings	Exact identifier application number: M017
Poison Ivy Wash	PRAMOXINE HCL	Chain Drug Market Association	873a546b-90ae-50cb-e053-2a91aa0adbfb	2023-12-20	Warnings	Exact identifier application number: M017
Premier Value Instant Antiseptic Pain Relief	CAMPHOR 10.8% AND PHENOL 4.7%	Pharmacy Value Alliance LLC	9d63f8ed-fc50-0d84-e053-2a95a90a6e92	2023-12-20	Warnings	Exact identifier application number: M017
Ear Drops	CARBAMIDE PEROXIDE 6.5%	CVS Pharmacy	8a872991-01af-5fd0-e053-2995a90ac7f4	2023-12-20	Warnings	Exact identifier application number: M017
CVS Cold and Hot Roll-On	COOL AND HEAT PAIN RELIEF	CVS Pharmacy	b8cc578a-be6d-90c0-e053-2995a90a7742	2023-12-20	Warnings	Exact identifier application number: M017
Sunmark Camphor Spirit	CAMPHOR 10%	Strategic Sourcing Services LLC	667b3a9f-4a5c-4ef0-adbd-cce9a5f94faa	2023-12-19	Warnings	Exact identifier application number: M017
DDM Instant Antiseptic Pain Relief	CAMPHOR 10.8% AND PHENOL 4.7%	Discount Drug Mart	5d56c74f-604d-4fed-e053-2a91aa0a417c	2023-12-19	Warnings	Exact identifier application number: M017
HEB Camphor Phenol	CAMPHOR 10.8% AND PHENOL 4.7%	H E B	5d573883-001d-e5a4-e053-2991aa0a6203	2023-12-18	Warnings	Exact identifier application number: M017
Petrocort Antipruritic Lip 21	HYDROCORTISONE	Clinical Formula LLC	7d408e08-d777-4dfb-bb5e-b4fe5d6f4c7b	2023-12-15	Warnings	Exact identifier application number: M017
DermaWound Wound Care Venous Stasis	BENZOCAINE HYDROCHLORIDE	Progressive Doctors, LLC	6221ba86-8b7f-48c8-8284-6950f9fc36b1	2023-12-15	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Roll-On	LIDOCAINE 4%	Humco Holding Group, Inc.	a8be9e46-1616-40a9-e053-2a95a90ac3bc	2023-12-15	Warnings	Exact identifier application number: M017
Hot/Cold Menthol 16% Roll-On	HOT/COLD MENTHOL 16% ROLL-ON	Humco Holding Group, Inc	a8bf9744-9979-13c1-e053-2a95a90a30aa	2023-12-15	Warnings	Exact identifier application number: M017
Freds Medicated anti itch	PRAMOXINE HYDROCHLORIDE, MENTHOL	Discount Drug Mart	8697b932-da5a-717e-e053-2a91aa0afcae	2023-12-12	Warnings	Exact identifier application number: M017
CVS Medicated anti itch	PRAMOXINE HYDROCHLORIDE, MENTHOL	CVS	86972218-31fe-6942-e053-2991aa0a8850	2023-12-12	Warnings	Exact identifier application number: M017
Best Choice Medicated anti itch	PRAMOXINE HYDROCHLORIDE, MENTHOL	value merchandisers	869631f8-aa1e-8ea4-e053-2a91aa0a5c57	2023-12-12	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE 1%	Weeks & Leo Co., Inc.	0c5325e3-4796-856c-e063-6394a90a1f90	2023-12-12	Warnings	Exact identifier application number: M017
Westlake Anti-itch	HYDROCORTISONE	Westlake Pharma LLC	0c53c982-3f23-a2d5-e063-6394a90acd55	2023-12-12	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