Soothing Advanced Arnica

Product NDC
57955-4000
11-digit product format
579554000
Labeler code
57955
Product ID
57955-4000_18d7a8c6-5e51-4510-a7fd-8be1e50d5a0a
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica montana, Arnica montana, radix
Dosage form
CREAM
Route
TOPICAL
Labeler
King Bio Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2012-07-18
Marketing end
0000-00-00
Substance
ARNICA MONTANA; ARNICA MONTANA ROOT
Active strength
6 [hp_X]/85g; [hp_X]/85g
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct57955-4000IInactivated by FDA2026-10-15
excluded packagepackage57955-400057955-4000-3IInactivated by FDA2026-10-15

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 packagepackage57955-4000-3IInactivated 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 packagepackage57955-4000-3IInactivated 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 packagepackage57955-4000-3IInactivated 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 packagepackage57955-4000-3IInactivated 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 packagepackage57955-4000-3IInactivated 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 packagepackage57955-4000-3IInactivated 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 packagepackage57955-4000-3IInactivated 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 packagepackage57955-4000-3IInactivated 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 packagepackage57955-4000-3IInactivated 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 packagepackage57955-4000-3IInactivated 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 packagepackage57955-4000-3IInactivated 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 packagepackage57955-4000-3IInactivated 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 packagepackage57955-4000-3IInactivated 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 packagepackage57955-4000-3IInactivated 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 packagepackage57955-4000-3IInactivated 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 packagepackage57955-4000-3IInactivated 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 packagepackage57955-4000-3IInactivated 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 packagepackage57955-4000-3IInactivated 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 packagepackage57955-4000-3IInactivated 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 packagepackage57955-4000-3IInactivated 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 packagepackage57955-4000-3IInactivated 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 packagepackage57955-4000-3EExcluded 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
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-4000-32020-01-31C16284748780-19d75b9d0-cb44-f424-e053-dadaa90a57ceSoothing Advanced Arnica™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-4000-3Soothing Advanced Arnica1 in 1 CARTONCREAM11
57955-4000-3Soothing Advanced Arnica85 g in 1 TUBECREAM851

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZWSOOTHING ADVANCED ARNICA (ARNICA MONTANA, ARNICA MONTANA, RADIX) CREAM [KING BIO INC.]1
ARNICA MONTANA ROOTACTIVE INGREDIENTMUE8Y11327SOOTHING ADVANCED ARNICA (ARNICA MONTANA, ARNICA MONTANA, RADIX) CREAM [KING BIO INC.]1
ARNICA MONTANAACTIVE MOIETYO80TY208ZWSOOTHING ADVANCED ARNICA (ARNICA MONTANA, ARNICA MONTANA, RADIX) CREAM [KING BIO INC.]1
ARNICA MONTANA ROOTACTIVE MOIETYMUE8Y11327SOOTHING ADVANCED ARNICA (ARNICA MONTANA, ARNICA MONTANA, RADIX) CREAM [KING BIO INC.]1
ALMOND OILINACTIVE INGREDIENT66YXD4DKO9SOOTHING ADVANCED ARNICA (ARNICA MONTANA, ARNICA MONTANA, RADIX) CREAM [KING BIO INC.]1
ARNICA CHAMISSONIS FLOWERINACTIVE INGREDIENT88WK5I8R3LSOOTHING ADVANCED ARNICA (ARNICA MONTANA, ARNICA MONTANA, RADIX) CREAM [KING BIO INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSOOTHING ADVANCED ARNICA (ARNICA MONTANA, ARNICA MONTANA, RADIX) CREAM [KING BIO INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SOOTHING ADVANCED ARNICA (ARNICA MONTANA, ARNICA MONTANA, RADIX) CREAM [KING BIO INC.]1
JOJOBA OILINACTIVE INGREDIENT724GKU717MSOOTHING ADVANCED ARNICA (ARNICA MONTANA, ARNICA MONTANA, RADIX) CREAM [KING BIO INC.]1
LEMON OILINACTIVE INGREDIENTI9GRO824LLSOOTHING ADVANCED ARNICA (ARNICA MONTANA, ARNICA MONTANA, RADIX) CREAM [KING BIO INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSOOTHING ADVANCED ARNICA (ARNICA MONTANA, ARNICA MONTANA, RADIX) CREAM [KING BIO INC.]1
POMEGRANATEINACTIVE INGREDIENT56687D1Z4DSOOTHING ADVANCED ARNICA (ARNICA MONTANA, ARNICA MONTANA, RADIX) CREAM [KING BIO INC.]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YSOOTHING ADVANCED ARNICA (ARNICA MONTANA, ARNICA MONTANA, RADIX) CREAM [KING BIO INC.]1
SODIUM LACTATEINACTIVE INGREDIENTTU7HW0W0QTSOOTHING ADVANCED ARNICA (ARNICA MONTANA, ARNICA MONTANA, RADIX) CREAM [KING BIO INC.]1
SODIUM STEAROYL LACTYLATEINACTIVE INGREDIENTIN99IT31LNSOOTHING ADVANCED ARNICA (ARNICA MONTANA, ARNICA MONTANA, RADIX) CREAM [KING BIO INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSOOTHING ADVANCED ARNICA (ARNICA MONTANA, ARNICA MONTANA, RADIX) CREAM [KING BIO INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-4000SOOTHING ADVANCED ARNICA (ARNICA MONTANA, ARNICA MONTANA, RADIX) CREAM [KING BIO INC.]1Legacy NDC, 2 package rows20140929_ef8ef0f9-d09b-4066-87e3-1c9356730ead.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
57955-4000-3579554000031 in 1 CARTONHistorical