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.
| 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 |
|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Ralli Rapid Pain Relief Roll on | MENTHOL | Troy Manufacturing, Inc. | 978d5c2c-fdc4-4d25-83ec-0b9404ec8018 | 2024-02-19 | Warnings | M017 |
| 1168 | 1168 BURN SPRAY | Dynarex Corporation | 1183a4f5-f875-dfb0-e063-6394a90af35f | 2024-02-16 | Warnings | M017 |
| Pain Relief | BENZOCAINE | Safetec of America, Inc. | de84e598-d047-4fae-b2ed-155a3788bc6f | 2024-02-16 | Warnings | M017 |
| No Mess Hydrocortisone Applicator | HYDROCORTISONE | Walgreen Co. | cfefb517-9099-41c4-8a95-74414ca4032c | 2024-02-16 | Warnings | M017 |
| Analgesic Balm | MENTHOL 10%, METHYL SALICYLATE 15% | Geri-Care Pharmaceuticals, Corp | ab9bf09d-bc8c-6d17-e053-2995a90a6c36 | 2024-02-14 | Warnings | M017 |
| Natures Oil 16% Menthol | MENTHOL, UNSPECIFIED FORM | NATURAL ESSENTIALS, INC. | 2fbe23b7-23a3-4f0b-bc08-0205256f5d68 | 2024-02-14 | Warnings | M017 |
| Rugby Pain Relieving Analgesic | MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE | Rugby Laboratories | 4c11876c-57ec-4429-a8c4-fb95baa4074a | 2024-02-13 | Warnings | M017 |
| Itch stopping Cream | DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1% | Trifecta Pharmaceuticals USA, LLC. | 11368823-d4af-a536-e063-6294a90a7a2e | 2024-02-12 | Warnings | M017 |
| Walgreens Boil Pain Relief | BOIL PAIN RELIEF | Walgreens Company | d11bd769-68d0-4057-bc2a-72719f16011e | 2024-02-12 | Warnings | M017 |
| Capsaicin | CAPSAICIN | Rugby Laboratories | c5915c84-84a2-46f6-9f97-0d9873e9944a | 2024-02-12 | Warnings | M017 |
| Leader Ice Blue Analgesic | MENTHOL, UNSPECIFIED FORM | Cardinal Health, 110 dba LEADER | 952e56ea-5cbc-4078-bd01-5d3b6864a5ce | 2024-02-09 | Warnings | M017 |
| Leader Ultra Strength Muscle Rub Topical Analgesic | CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE | Cardinal Health, 110 dba LEADER | 9d99a900-60e0-454c-98e0-2c63eb910cf1 | 2024-02-09 | Warnings | M017 |
| Pain Relieving | CAMPHOR (NATURAL) | J.R. Watkins, LLC. | 28821ffa-a138-47b5-8857-beadf7a20d43 | 2024-02-08 | Warnings | M017 |
| Menthol Camphor Cough Suppressant Topical Analgesic Rub | CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM | J.R. Watkins, LLC. | fd0ea70a-ef12-48b1-8d9d-cc5f6417f854 | 2024-02-08 | Warnings | M017 |
| Pain Relieving Cooling | MENTHOL, UNSPECIFIED FORM | J.R. Watkins, LLC. | 3574d48a-b546-4ea7-b470-071bb328de64 | 2024-02-08 | Warnings | M017 |
| Advil Targeted Relief | CAMPHOR, CAPSAICIN, MENTHOL, METHYL SALICYLATE | Haleon US Holdings LLC | 16e6be21-7b43-443a-89ec-3bdf0ec0dfc1 | 2024-02-08 | Warnings | M017 |
| POINT RELIEF COLD SPOT Pain Relieving | MENTHOL | FABRICATION ENTERPRISES | 96f1d592-6cec-412e-a5fd-cf3c4f68644f | 2024-02-07 | Warnings | M017 |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Safetec of America, Inc. | 1c5eb3b3-79b3-472a-ae36-ec6a7dc72925 | 2024-02-07 | Warnings | M017 |
| Lidocaine Hydrochloride | LIDOCAINE HYDROCHLORIDE | Safetec of America, Inc. | 8eb3e7e2-26e5-430e-89aa-40a0367c637e | 2024-02-07 | Warnings | M017 |
| Nova Natura Topical Analgesic | CAMPHOR, CAPSICUM OLEORESIN, METHYL SALICYLATE | SEYITLER KIMYA SANAYI ANONIM SIRKETI | abf00f73-f0b1-439e-85aa-bbce8a1ec920 | 2024-02-06 | 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 |