AmeriPatch

Product NDC
69418-003
11-digit product format
694180003
Labeler code
69418
Product ID
69418-003_24d867c0-ac2a-683c-e054-00144ff8d46c
Type
HUMAN OTC DRUG
Nonproprietary name
menthol and capsaicin
Dosage form
PATCH
Route
TOPICAL
Labeler
Meds Direct Rx, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-01-31
Marketing end
0000-00-00
Substance
MENTHOL; CAPSAICIN
Active strength
5 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 productproduct69418-003IInactivated by FDA2026-10-12
excluded packagepackage69418-00369418-003-15IInactivated by FDA2026-10-12

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 · 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 packagepackage69418-003-15IInactivated 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 packagepackage69418-003-15IInactivated 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 packagepackage69418-003-15IInactivated 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 packagepackage69418-003-15IInactivated 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 packagepackage69418-003-15IInactivated 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 packagepackage69418-003-15IInactivated 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 packagepackage69418-003-15IInactivated 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 packagepackage69418-003-15IInactivated 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 packagepackage69418-003-15IInactivated 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 packagepackage69418-003-15IInactivated 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 packagepackage69418-003-15IInactivated 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 packagepackage69418-003-15IInactivated 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 packagepackage69418-003-15IInactivated 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 packagepackage69418-003-15IInactivated 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 packagepackage69418-003-15IInactivated 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 packagepackage69418-003-15IInactivated 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 packagepackage69418-003-15IInactivated 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 packagepackage69418-003-15IInactivated 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 packagepackage69418-003-15IInactivated 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 packagepackage69418-003-15IInactivated 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 packagepackage69418-003-15IInactivated 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 packagepackage69418-003-15EExcluded 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
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69418-003-152020-01-31C16284748780-19d75b9d0-267a-f424-e053-dadaa90a57ceAmeriPatch (69418-003)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69418-003-15AmeriPatch5 in 1 POUCHPATCH510
69418-003-15AmeriPatch3 in 1 BOXPATCH310

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZMAMERIPATCH (MENTHOL AND CAPSAICIN) PATCH [MEDS DIRECT RX, INC.]10
MENTHOLACTIVE INGREDIENTL7T10EIP3AAMERIPATCH (MENTHOL AND CAPSAICIN) PATCH [MEDS DIRECT RX, INC.]10
CAPSAICINACTIVE MOIETYS07O44R1ZMAMERIPATCH (MENTHOL AND CAPSAICIN) PATCH [MEDS DIRECT RX, INC.]10
MENTHOLACTIVE MOIETYL7T10EIP3AAMERIPATCH (MENTHOL AND CAPSAICIN) PATCH [MEDS DIRECT RX, INC.]10
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XAMERIPATCH (MENTHOL AND CAPSAICIN) PATCH [MEDS DIRECT RX, INC.]10
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4AMERIPATCH (MENTHOL AND CAPSAICIN) PATCH [MEDS DIRECT RX, INC.]10
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAMERIPATCH (MENTHOL AND CAPSAICIN) PATCH [MEDS DIRECT RX, INC.]10
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAMERIPATCH (MENTHOL AND CAPSAICIN) PATCH [MEDS DIRECT RX, INC.]10
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEBAMERIPATCH (MENTHOL AND CAPSAICIN) PATCH [MEDS DIRECT RX, INC.]10
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAMERIPATCH (MENTHOL AND CAPSAICIN) PATCH [MEDS DIRECT RX, INC.]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAMERIPATCH (MENTHOL AND CAPSAICIN) PATCH [MEDS DIRECT RX, INC.]10
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAMERIPATCH (MENTHOL AND CAPSAICIN) PATCH [MEDS DIRECT RX, INC.]10
SODIUM POLYACRYLATE (2500000 MW)INACTIVE INGREDIENT05I15JNI2JAMERIPATCH (MENTHOL AND CAPSAICIN) PATCH [MEDS DIRECT RX, INC.]10
WATERINACTIVE INGREDIENT059QF0KO0RAMERIPATCH (MENTHOL AND CAPSAICIN) PATCH [MEDS DIRECT RX, INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69418-003AMERIPATCH (MENTHOL AND CAPSAICIN) PATCH [MEDS DIRECT RX, INC.]10Legacy NDC, 2 package rows20151119_0de1b20b-39a5-1302-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1300889capsaicin 0.0375 % / menthol 5 % Medicated PatchPSN0de1b20b-39a5-1302-e054-00144ff88e8810
1300889capsaicin 0.000375 MG/MG / menthol 0.05 MG/MG Medicated PatchSCD0de1b20b-39a5-1302-e054-00144ff88e8810
1300889capsaicin 0.0375 % / menthol 5 % Medicated PatchSY0de1b20b-39a5-1302-e054-00144ff88e8810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69418-003-15694180003155 in 1 POUCHHistorical