Roxalia

Product NDC: 0220-9321
Requested package NDC: 0220-9321-04
11-digit product format: 002209321
Labeler code: 0220
Product ID: 0220-9321_5d55f64d-6243-c895-e053-2a91aa0a4284
Type: HUMAN OTC DRUG
Nonproprietary name: ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED
Dosage form: TABLET
Route: ORAL
Labeler: Laboratoires Boiron
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2013-10-01
Marketing end: 0000-00-00
Substance: ARNICA MONTANA; ARISAEMA TRIPHYLLUM ROOT; BELLADONNA LEAF; BROMINE; BRYONIA ALBA ROOT; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SPONGIA OFFICINALIS SKELETON, ROASTED
Active strength: 3 [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0220-9321	0220-9321-04	D	Discontinued by firm		2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
NDC	Effective	Action	Document	Indexing SPL	Related label
0220-9321-04	2023-11-29	C162847	48780-1	f386c649-e3df-0266-e053-dadaa90a7c1a	ROXALIA
0220-9321-04	2023-01-30	C162847	48780-1	f386c649-e3df-0266-e053-dadaa90a7c1a	ROXALIA

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ARISAEMA TRIPHYLLUM ROOT	ACTIVE INGREDIENT	DM64K844DM	ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED) TABLET [LABORATOIRES BOIRON]	3
ARNICA MONTANA	ACTIVE INGREDIENT	O80TY208ZW	ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED) TABLET [LABORATOIRES BOIRON]	3
BELLADONNA LEAF	ACTIVE INGREDIENT	6GZW20TIOI	ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED) TABLET [LABORATOIRES BOIRON]	3
BROMINE	ACTIVE INGREDIENT	SBV4XY874G	ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED) TABLET [LABORATOIRES BOIRON]	3
BRYONIA ALBA ROOT	ACTIVE INGREDIENT	T7J046YI2B	ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED) TABLET [LABORATOIRES BOIRON]	3
MERCURIUS SOLUBILIS	ACTIVE INGREDIENT	324Y4038G2	ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED) TABLET [LABORATOIRES BOIRON]	3
PHYTOLACCA AMERICANA ROOT	ACTIVE INGREDIENT	11E6VI8VEG	ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED) TABLET [LABORATOIRES BOIRON]	3
PULSATILLA VULGARIS	ACTIVE INGREDIENT	I76KB35JEV	ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED) TABLET [LABORATOIRES BOIRON]	3
SPONGIA OFFICINALIS SKELETON, ROASTED	ACTIVE INGREDIENT	1PIP394IID	ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED) TABLET [LABORATOIRES BOIRON]	3
ARISAEMA TRIPHYLLUM ROOT	ACTIVE MOIETY	DM64K844DM	ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED) TABLET [LABORATOIRES BOIRON]	3
ARNICA MONTANA	ACTIVE MOIETY	O80TY208ZW	ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED) TABLET [LABORATOIRES BOIRON]	3
BELLADONNA LEAF	ACTIVE MOIETY	6GZW20TIOI	ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED) TABLET [LABORATOIRES BOIRON]	3
BROMINE	ACTIVE MOIETY	SBV4XY874G	ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED) TABLET [LABORATOIRES BOIRON]	3
BRYONIA ALBA ROOT	ACTIVE MOIETY	T7J046YI2B	ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED) TABLET [LABORATOIRES BOIRON]	3
MERCURIUS SOLUBILIS	ACTIVE MOIETY	324Y4038G2	ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED) TABLET [LABORATOIRES BOIRON]	3
PHYTOLACCA AMERICANA ROOT	ACTIVE MOIETY	11E6VI8VEG	ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED) TABLET [LABORATOIRES BOIRON]	3
PULSATILLA VULGARIS	ACTIVE MOIETY	I76KB35JEV	ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED) TABLET [LABORATOIRES BOIRON]	3
SPONGIA OFFICINALIS SKELETON, ROASTED	ACTIVE MOIETY	1PIP394IID	ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED) TABLET [LABORATOIRES BOIRON]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED) TABLET [LABORATOIRES BOIRON]	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED) TABLET [LABORATOIRES BOIRON]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ROXALIA (ARNICA MONTANA, ARISAEMA TRIPHYLLUM ROOT, BELLADONNA LEAF, BROMINE, BRYONIA ALBA ROOT, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED) TABLET [LABORATOIRES BOIRON]	3

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O80TY208ZW	ARNICA MONTANA	8057-65-6	ARNICA MONTANA
DM64K844DM	ARISAEMA TRIPHYLLUM ROOT		ARISAEMA TRIPHYLLUM ROOT
6GZW20TIOI	BELLADONNA LEAF		BELLADONNA LEAF
SBV4XY874G	BROMINE	7726-95-6	BROMINE
T7J046YI2B	BRYONIA ALBA ROOT		BRYONIA ALBA ROOT
324Y4038G2	MERCURIUS SOLUBILIS		MERCURIUS SOLUBILIS
11E6VI8VEG	PHYTOLACCA AMERICANA ROOT		PHYTOLACCA AMERICANA ROOT
1PIP394IID	SPONGIA OFFICINALIS SKELETON, ROASTED		SPONGIA OFFICINALIS SKELETON, ROASTED

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0220-9321-04	00220932104	60 TABLET in 1 BLISTER PACK (0220-9321-04)	60 tablet	2013-10-01	0000-00-00	No	No	Current