FDA.reportPublic FDA data

EB301CT BRUISE PAIN RELIEF

Product NDC
53304-1301
Requested package NDC
53304-1301-1
11-digit product format
533041301
Labeler code
53304
Product ID
53304-1301_a3e06c9e-cfbe-497c-9920-75f4183b2a85
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
SPRAY
Route
TOPICAL
Labeler
EMINENCE BIOTECH CORPORATION LIMITED
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-03-01
Marketing end
0000-00-00
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
1700 mg/100mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53304-130153304-1301-1IInactivated by FDA2026-11-12

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53304-1301-12023-01-30C16284748780-1f386c649-d3bc-0266-e053-dadaa90a7c1aEB301CT BRUISE PAIN RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53304-1301-1EB301CT BRUISE PAIN RELIEF1 in 1 BOXSPRAY12
53304-1301-1EB301CT BRUISE PAIN RELIEF100 mL in 1 BOTTLE, SPRAYSPRAY1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AEB301CT BRUISE PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]1
MENTHOLACTIVE MOIETYL7T10EIP3AEB301CT BRUISE PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MEB301CT BRUISE PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]1
AMARANTHUS VIRIDIS LEAFINACTIVE INGREDIENT7T0WZ76K1TEB301CT BRUISE PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]1
EUPHORBIA THYMIFOLIA WHOLEINACTIVE INGREDIENTD56Y3D2OTLEB301CT BRUISE PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]1
GAULTHERIA PROCUMBENS LEAFINACTIVE INGREDIENT2125M16OWNEB301CT BRUISE PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEB301CT BRUISE PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]1
PORK SIDE BACON, CURED FATINACTIVE INGREDIENT6E710H379SEB301CT BRUISE PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]1
WATERINACTIVE INGREDIENT059QF0KO0REB301CT BRUISE PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53304-1301EB301CT BRUISE PAIN RELIEF (MENTHOL) SPRAY [EMINENCE BIOTECH CORPORATION LIMITED]2Legacy NDC, 2 package rows20180321_5453a39c-d070-4f61-92b9-25d435736023.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1371294menthol 1.7 % Topical SprayPSN5453a39c-d070-4f61-92b9-25d4357360232
1371294menthol 17 MG/ML Topical SpraySCD5453a39c-d070-4f61-92b9-25d4357360232
1371294menthol 1.7 % Topical SpraySY5453a39c-d070-4f61-92b9-25d4357360232

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53304-1301-1533041301011 BOTTLE, SPRAY in 1 BOX (53304-1301-1) > 100 mL in 1 BOTTLE, SPRAY2013-03-010000-00-00NoNoCurrent