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.
| 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 |
|---|---|
| METHYL SALICYLATE | 105 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| LAV5U5022Y | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2719838 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 08819ad0-97c2-49bd-b923-535b94a27167 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
FDA-Initiated Inactive NDC Indexing#
| 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 | 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#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dr Sabharwals | METHYL SALICYLATE 10% GEL PATCH | Dr. Sabharwal's Wound Care | 4a7790bb-25cb-72b8-e063-6294a90a6b9c | 2026-06-29 | Warnings | M017 |
| Calamine Plus Pramoxine HCl | CALAMINE PLUS SPRAY | Target Corporation | 36602b7a-99c0-f6a4-e063-6294a90a8758 | 2026-06-29 | Warnings | M017 |
| FIRST SHIELD | BENZALKONIUM CHLORIDE, LIDOCAINE HCI | Unishield | f86f7446-b741-9f40-e053-6394a90a4422 | 2026-06-29 | Warnings | M017 |
| MQ Lidocaine Pain Relief Patch | LIDOCAINE PAIN RELIEF PATCH | Zhengzhou Miaoqi Medical Technology Co., Ltd. | 5560cdab-cee8-f6ec-e063-6294a90ad024 | 2026-06-29 | Warnings | M017 |
| GNP Lidocaine Maximum Strength | LIDOCAINE HCL | AMERISOURCE BERGEN | 9f559c20-c9ac-e480-e053-2a95a90a8fce | 2026-06-29 | Warnings | M017 |
| NUMBING | LIDOCAINE | YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED | 5553385d-c1e6-1242-e063-6394a90aa5a7 | 2026-06-28 | Warnings | M017 |
| MOROVAN | LIDOCAINE | HONG KONG UNORDERED TRADING CO., LIMITED | 550c8d2d-e0d7-1531-e063-6394a90a374d | 2026-06-25 | Warnings | M017 |
| Marie Originals Medicated Outdoor Anti Itch | HYDROCORTISONE SPRAY | Marie's Original Formulas, LLC | 5517ee5f-1c51-cfd6-e063-6294a90af56f | 2026-06-25 | Warnings | M017 |
| Marie Originals Medicated Outdoor Anti Itch | HYDROCORTISONE SPRAY | Marie's Original Formulas LLC | 55188ede-68cd-fcc6-e063-6394a90a5c58 | 2026-06-25 | Warnings | M017 |
| Hydrocortisone with Aloe | HYDROCORTISONE CREAM 1% | NuCare Pharmaceuticals, Inc. | 54f07a23-213f-ca46-e063-6394a90a0034 | 2026-06-24 | Warnings | M017 |
| Terramed Just Think Comfort HerpCare EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATION | MENTHOL,PRAMOXINE HYDROCHLORIDE | Rida LLC | b62d09e4-7ced-49a9-8c83-3a8ef580f25a | 2026-06-23 | Warnings | M017 |
| Terramed Just Think Comfort HerpCare Intimate Wash EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATION | PRAMOXINE HYDROCHLORIDE | Rida LLC | 5b2cb1bd-2f1e-4670-b40e-6c058bfd12a2 | 2026-06-23 | Warnings | M017 |
| Pain Relieving cleansing spary | BENZALKONIUM CHLORIDE AND LIDOCAINE HCI | Trifecta Pharmaceuticals USA, LLC. | 48edbb8d-0c35-91d8-e063-6394a90a71b8 | 2026-06-19 | Warnings | M017 |
| Pain Relief | MENTHOL | Trifecta Pharmaceuticals USA, LLC. | 493ab515-5cda-7b5a-e063-6294a90a295b | 2026-06-19 | Warnings | M017 |
| Tiger Balm Muscle Rub | METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC) | Haw Par Healthcare Ltd. | 011fc383-10bc-44cf-a67c-4be45fef33e0 | 2026-06-19 | Warnings | M017 |
| CVS Health Scalp Relief | SALICYLIC ACID | CVS Health | 8de46015-817c-4cd9-95f8-293424f2a5c4 | 2026-06-19 | Warnings | M017 |
| Careland Kinesiology Dual Action Pain Relieving Tape | LIDOCAINE | Planet (Anhui) Pharmaceutical Co., Ltd. | 67e0b3c5-e88e-4c48-a1e8-39f502ac249d | 2026-06-18 | Warnings | M017 |
| Zensa | LIDOCAINE | Alera Skin Care Products Inc. | 549348ec-2eb2-3781-e063-6294a90a2f4a | 2026-06-18 | Warnings | M017 |
| SprayPain Away | CAPSAICIN | Proximity Capital Partners LLC dba Asutra | c603e999-2316-496a-e053-2995a90ab4ed | 2026-06-17 | Warnings | M017 |
| SprayPain Away Lavender | CAPSAICIN | Proximity Capital Partners LLC dba Asutra | 547e2167-ade0-ac7e-e063-6294a90a18ea | 2026-06-17 | Warnings | M017 |
DailyMed RxNorm Mappings#
| 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 | 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 |