BenePatch

Product NDC
69418-002
11-digit product format
694180002
Labeler code
69418
Product ID
69418-002_24d86c23-664b-00dc-e054-00144ff8d46c
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE, MENTHOL
Dosage form
PATCH
Route
TOPICAL
Labeler
Meds Direct Rx, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-01-24
Marketing end
0000-00-00
Substance
MENTHOL; LIDOCAINE HYDROCHLORIDE
Active strength
1 g/100g; g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69418-002IInactivated by FDA2026-10-05
excluded packagepackage69418-00269418-002-01IInactivated by FDA2026-10-05

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69418-002-01IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69418-002-01IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69418-002-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69418-002-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69418-002-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69418-002-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69418-002-01IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69418-002-01IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69418-002-01IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69418-002-01IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69418-002-01IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69418-002-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69418-002-01IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69418-002-01IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69418-002-01IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69418-002-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69418-002-01IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69418-002-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage69418-002-01IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69418-002-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage69418-002-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage69418-002-01EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69418-002-012020-01-31C16284748780-19d75b9d0-ac39-f424-e053-dadaa90a57ceBenePatch (69418-002)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69418-002-01BenePatch3 in 1 BOXPATCH311
69418-002-01BenePatch5 in 1 POUCHPATCH511

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ABENEPATCH (LIDOCAINE HYDROCHLORIDE, MENTHOL) PATCH [MEDS DIRECT RX, INC.]11
MENTHOLACTIVE INGREDIENTL7T10EIP3ABENEPATCH (LIDOCAINE HYDROCHLORIDE, MENTHOL) PATCH [MEDS DIRECT RX, INC.]11
LIDOCAINEACTIVE MOIETY98PI200987BENEPATCH (LIDOCAINE HYDROCHLORIDE, MENTHOL) PATCH [MEDS DIRECT RX, INC.]11
MENTHOLACTIVE MOIETYL7T10EIP3ABENEPATCH (LIDOCAINE HYDROCHLORIDE, MENTHOL) PATCH [MEDS DIRECT RX, INC.]11
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBENEPATCH (LIDOCAINE HYDROCHLORIDE, MENTHOL) PATCH [MEDS DIRECT RX, INC.]11
ARNICA MONTANAINACTIVE INGREDIENTO80TY208ZWBENEPATCH (LIDOCAINE HYDROCHLORIDE, MENTHOL) PATCH [MEDS DIRECT RX, INC.]11
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EBENEPATCH (LIDOCAINE HYDROCHLORIDE, MENTHOL) PATCH [MEDS DIRECT RX, INC.]11
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PBENEPATCH (LIDOCAINE HYDROCHLORIDE, MENTHOL) PATCH [MEDS DIRECT RX, INC.]11
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBENEPATCH (LIDOCAINE HYDROCHLORIDE, MENTHOL) PATCH [MEDS DIRECT RX, INC.]11
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MBENEPATCH (LIDOCAINE HYDROCHLORIDE, MENTHOL) PATCH [MEDS DIRECT RX, INC.]11
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENEPATCH (LIDOCAINE HYDROCHLORIDE, MENTHOL) PATCH [MEDS DIRECT RX, INC.]11
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0BENEPATCH (LIDOCAINE HYDROCHLORIDE, MENTHOL) PATCH [MEDS DIRECT RX, INC.]11
INDIAN FRANKINCENSEINACTIVE INGREDIENT4PW41QCO2MBENEPATCH (LIDOCAINE HYDROCHLORIDE, MENTHOL) PATCH [MEDS DIRECT RX, INC.]11
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSBENEPATCH (LIDOCAINE HYDROCHLORIDE, MENTHOL) PATCH [MEDS DIRECT RX, INC.]11
PEG-8 STEARATEINACTIVE INGREDIENT2P9L47VI5EBENEPATCH (LIDOCAINE HYDROCHLORIDE, MENTHOL) PATCH [MEDS DIRECT RX, INC.]11
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TBENEPATCH (LIDOCAINE HYDROCHLORIDE, MENTHOL) PATCH [MEDS DIRECT RX, INC.]11
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBENEPATCH (LIDOCAINE HYDROCHLORIDE, MENTHOL) PATCH [MEDS DIRECT RX, INC.]11
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JBENEPATCH (LIDOCAINE HYDROCHLORIDE, MENTHOL) PATCH [MEDS DIRECT RX, INC.]11
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKBENEPATCH (LIDOCAINE HYDROCHLORIDE, MENTHOL) PATCH [MEDS DIRECT RX, INC.]11
WATERINACTIVE INGREDIENT059QF0KO0RBENEPATCH (LIDOCAINE HYDROCHLORIDE, MENTHOL) PATCH [MEDS DIRECT RX, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69418-002BENEPATCH (LIDOCAINE HYDROCHLORIDE, MENTHOL) PATCH [MEDS DIRECT RX, INC.]11Legacy NDC, 2 package rows20151119_0ce3c764-b905-418a-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373130lidocaine HCl 4 % / menthol 1 % Medicated PatchPSN0ce3c764-b905-418a-e054-00144ff8d46c11
1373130lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD0ce3c764-b905-418a-e054-00144ff8d46c11
1373130lidocaine HCl 4 % / menthol 1 % Medicated PatchSY0ce3c764-b905-418a-e054-00144ff8d46c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69418-002-01694180002013 in 1 BOXHistorical