Arnica Performance Gel

Product NDC
41391-121
11-digit product format
413910121
Labeler code
41391
Product ID
41391-121_22fc0589-e2b6-4bbe-9933-bc3c64eca929
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica Montana
Dosage form
GEL
Route
TOPICAL
Labeler
Myo-Breathe,LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2015-06-25
Marketing end
0000-00-00
Substance
ARNICA MONTANA
Active strength
150 mg/mL
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct41391-121DDiscontinued by firm2026-09-14
excluded packagepackage41391-12141391-121-20DDiscontinued by firm2026-09-14
excluded packagepackage41391-12141391-121-21DDiscontinued by firm2026-09-14

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 2 · 66 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 productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage41391-121-21DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage41391-121-20DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41391-121-21DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41391-121-20DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage41391-121-21DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage41391-121-20DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage41391-121-21DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage41391-121-20DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage41391-121-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage41391-121-20DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage41391-121-21DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage41391-121-20DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41391-121-21DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41391-121-20DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41391-121-21DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41391-121-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41391-121-21DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41391-121-20DDiscontinued by firm0efc9e666f02…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 packagepackage41391-121-20IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage41391-121-21IInactivated 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 packagepackage41391-121-20IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage41391-121-21IInactivated 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 packagepackage41391-121-20IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage41391-121-21IInactivated 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 packagepackage41391-121-20IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage41391-121-21IInactivated 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 packagepackage41391-121-20IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage41391-121-21IInactivated 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 packagepackage41391-121-20IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage41391-121-21IInactivated 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 packagepackage41391-121-20IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage41391-121-21IInactivated 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 packagepackage41391-121-20IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage41391-121-21IInactivated 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 packagepackage41391-121-20IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage41391-121-21IInactivated 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 packagepackage41391-121-20IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage41391-121-21IInactivated 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 packagepackage41391-121-20IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage41391-121-21IInactivated by FDAe2bbac7714bc…27bdfed8d636…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
41391-121-202025-01-03Drug Facts
41391-121-212025-01-03Drug Facts
41391-121-202020-01-31Drug Facts
41391-121-212020-01-31Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZWARNICA PERFORMANCE GEL (ARNICA MONTANA) GEL [MYO-BREATHE,LLC]1
ARNICA MONTANAACTIVE MOIETYO80TY208ZWARNICA PERFORMANCE GEL (ARNICA MONTANA) GEL [MYO-BREATHE,LLC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XARNICA PERFORMANCE GEL (ARNICA MONTANA) GEL [MYO-BREATHE,LLC]1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ARNICA PERFORMANCE GEL (ARNICA MONTANA) GEL [MYO-BREATHE,LLC]1
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESINACTIVE INGREDIENTU72Q2I8C85ARNICA PERFORMANCE GEL (ARNICA MONTANA) GEL [MYO-BREATHE,LLC]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UARNICA PERFORMANCE GEL (ARNICA MONTANA) GEL [MYO-BREATHE,LLC]1
CARBOMER 934INACTIVE INGREDIENTZ135WT9208ARNICA PERFORMANCE GEL (ARNICA MONTANA) GEL [MYO-BREATHE,LLC]1
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTARNICA PERFORMANCE GEL (ARNICA MONTANA) GEL [MYO-BREATHE,LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXARNICA PERFORMANCE GEL (ARNICA MONTANA) GEL [MYO-BREATHE,LLC]1
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FARNICA PERFORMANCE GEL (ARNICA MONTANA) GEL [MYO-BREATHE,LLC]1
ISODECYL NEOPENTANOATEINACTIVE INGREDIENTW60VYE24XCARNICA PERFORMANCE GEL (ARNICA MONTANA) GEL [MYO-BREATHE,LLC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ARNICA PERFORMANCE GEL (ARNICA MONTANA) GEL [MYO-BREATHE,LLC]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62ARNICA PERFORMANCE GEL (ARNICA MONTANA) GEL [MYO-BREATHE,LLC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TARNICA PERFORMANCE GEL (ARNICA MONTANA) GEL [MYO-BREATHE,LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IARNICA PERFORMANCE GEL (ARNICA MONTANA) GEL [MYO-BREATHE,LLC]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BARNICA PERFORMANCE GEL (ARNICA MONTANA) GEL [MYO-BREATHE,LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RARNICA PERFORMANCE GEL (ARNICA MONTANA) GEL [MYO-BREATHE,LLC]1