FibroCane CALM

Product NDC: 57850-0001
11-digit product format: 578500001
Labeler code: 57850
Product ID: 57850-0001_51938eb2-9193-4eba-a44c-986cb7195b35
Type: HUMAN OTC DRUG
Nonproprietary name: Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Pulsatilla, Valeriana officinalis
Dosage form: LIQUID
Route: ORAL
Labeler: Premier Bioceuticals LLC.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2013-10-31
Marketing end: 0000-00-00
Substance: ACONITUM NAPELLUS; AESCULUS HIPPOCASTANUM FLOWER; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; ATROPA BELLADONNA; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFOLUM ROOT; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; PASSIFLORA INCARNATA FLOWERING TOP; PULSATILLA VULGARIS; VALERIAN
Active strength: 10 [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	57850-0001		I	Inactivated by FDA		2026-10-05
excluded package	package	57850-0001	57850-0001-1	I	Inactivated by FDA		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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57850-0001-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57850-0001-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57850-0001-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57850-0001-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57850-0001-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57850-0001-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57850-0001-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57850-0001-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57850-0001-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57850-0001-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57850-0001-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57850-0001-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	57850-0001-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	57850-0001-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	57850-0001-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	57850-0001-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	57850-0001-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	57850-0001-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	57850-0001-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	57850-0001-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	57850-0001-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	57850-0001-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`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 concept	Relation	Version	Effective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139	Product name	3	20240506
e5a77e9c-c528-733a-173d-914a234c024b	Product name	5	20240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57850-0001-1	2020-01-31	C162847	48780-1	9d75b9cf-efc6-f424-e053-dadaa90a57ce	FibroCane CALM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57850-0001-1	FibroCane CALM	29.6 mL in 1 BOTTLE, SPRAY	LIQUID	29.6		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACONITUM NAPELLUS	ACTIVE INGREDIENT	U0NQ8555JD	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
AESCULUS HIPPOCASTANUM FLOWER	ACTIVE INGREDIENT	KK0Z92II8M	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
ARABICA COFFEE BEAN	ACTIVE INGREDIENT	3SW678MX72	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
ARSENIC TRIOXIDE	ACTIVE INGREDIENT	S7V92P67HO	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
ATROPA BELLADONNA	ACTIVE INGREDIENT	WQZ3G9PF0H	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
AVENA SATIVA FLOWERING TOP	ACTIVE INGREDIENT	MA9CQJ3F7F	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
CAMPHOR (NATURAL)	ACTIVE INGREDIENT	N20HL7Q941	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
CINCHONA OFFICINALIS BARK	ACTIVE INGREDIENT	S003A158SB	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
CYPRIPEDIUM PARVIFOLUM ROOT	ACTIVE INGREDIENT	21Y9GZ1LZA	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
HYOSCYAMUS NIGER	ACTIVE INGREDIENT	4WRK2153H3	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
PASSIFLORA INCARNATA FLOWERING TOP	ACTIVE INGREDIENT	CLF5YFS11O	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
PULSATILLA VULGARIS	ACTIVE INGREDIENT	I76KB35JEV	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
STRYCHNOS IGNATII SEED	ACTIVE INGREDIENT	1NM3M2487K	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
VALERIAN	ACTIVE INGREDIENT	JWF5YAW3QW	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
ACONITUM NAPELLUS	ACTIVE MOIETY	U0NQ8555JD	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
AESCULUS HIPPOCASTANUM FLOWER	ACTIVE MOIETY	KK0Z92II8M	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
ARABICA COFFEE BEAN	ACTIVE MOIETY	3SW678MX72	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
ARSENIC CATION (3+)	ACTIVE MOIETY	C96613F5AV	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
ATROPA BELLADONNA	ACTIVE MOIETY	WQZ3G9PF0H	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
AVENA SATIVA FLOWERING TOP	ACTIVE MOIETY	MA9CQJ3F7F	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
CAMPHOR (NATURAL)	ACTIVE MOIETY	N20HL7Q941	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
CINCHONA OFFICINALIS BARK	ACTIVE MOIETY	S003A158SB	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
CYPRIPEDIUM PARVIFOLUM ROOT	ACTIVE MOIETY	21Y9GZ1LZA	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
HYOSCYAMUS NIGER	ACTIVE MOIETY	4WRK2153H3	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
PASSIFLORA INCARNATA FLOWERING TOP	ACTIVE MOIETY	CLF5YFS11O	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
PULSATILLA VULGARIS	ACTIVE MOIETY	I76KB35JEV	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
STRYCHNOS IGNATII SEED	ACTIVE MOIETY	1NM3M2487K	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
VALERIAN	ACTIVE MOIETY	JWF5YAW3QW	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57850-0001	FIBROCANE CALM (ACONITUM NAPELLUS, AESCULUS HIPPOCASTANUM, FLOS, ARSENICUM ALBUM, AVENA SATIVA, BELLADONNA, CAMPHORA, CINCHONA OFFICINALIS, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HYOSCYAMUS NIGER, IGNATIA AMARA, PASSIFLORA INCARNATA, PULSATILLA, VALERIANA OFFICINALIS) LIQUID [PREMIER BIOCEUTICALS LLC.]	1	Legacy NDC, 1 package rows	20140624_dea6be68-76fd-4a72-886e-d964b8b821d8.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U0NQ8555JD	ACONITUM NAPELLUS		ACONITUM NAPELLUS
KK0Z92II8M	AESCULUS HIPPOCASTANUM FLOWER		AESCULUS HIPPOCASTANUM FLOWER
S7V92P67HO	ARSENIC TRIOXIDE	1327-53-3	ARSENIC TRIOXIDE
MA9CQJ3F7F	AVENA SATIVA FLOWERING TOP		AVENA SATIVA FLOWERING TOP
WQZ3G9PF0H	ATROPA BELLADONNA		ATROPA BELLADONNA
N20HL7Q941	CAMPHOR (NATURAL)	464-49-3	CAMPHOR (NATURAL)
S003A158SB	CINCHONA OFFICINALIS BARK		CINCHONA OFFICINALIS BARK
3SW678MX72	ARABICA COFFEE BEAN		ARABICA COFFEE BEAN
4WRK2153H3	HYOSCYAMUS NIGER		HYOSCYAMUS NIGER
1NM3M2487K	STRYCHNOS IGNATII SEED		STRYCHNOS IGNATII SEED
CLF5YFS11O	PASSIFLORA INCARNATA FLOWERING TOP		PASSIFLORA INCARNATA FLOWERING TOP
JWF5YAW3QW	VALERIAN	8057-49-6	VALERIAN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
57850-0001-1	57850000101	29.6 mL in 1 BOTTLE, SPRAY	29.6 ml	Historical