BLACK

Product NDC: 43406-0135
11-digit product format: 434060135
Labeler code: 43406
Product ID: 43406-0135_37c52945-f224-4eb5-ac99-dee1809d3edf
Type: HUMAN OTC DRUG
Nonproprietary name: Echinacea Ang., Hydrastis, Phytolacca, Plantago, Stellaria Med., Symphytum, Trifolium Prat., Verbascum, Arsenicum Alb., Bufo, Lachesis, Lycopodium, Sepia, Silicea, Thuja Occ.
Dosage form: GEL
Route: TOPICAL
Labeler: Natural Creations, Inc
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2007-05-20
Marketing end: 0000-00-00
Substance: ECHINACEA ANGUSTIFOLIA WHOLE; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; PLANTAGO MAJOR WHOLE; STELLARIA MEDIA; COMFREY LEAF; TRIFOLIUM PRATENSE FLOWER; VERBASCUM THAPSUS WHOLE; ARSENIC TRIOXIDE; BUFO BUFO CUTANEOUS GLAND; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG
Active strength: 1 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
NDC exclude flag: No
Listing certified through: 2021-12-31
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	43406-0135		I	Inactivated by FDA		2026-10-05
excluded package	package	43406-0135	43406-0135-2	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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43406-0135-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43406-0135-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43406-0135-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43406-0135-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43406-0135-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43406-0135-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43406-0135-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43406-0135-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43406-0135-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43406-0135-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43406-0135-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43406-0135-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43406-0135-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43406-0135-2	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43406-0135-2	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43406-0135-2	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43406-0135-2	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43406-0135-2	`bd6a592717d7…`	`303034d00443…`

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
43406-0135-2	2022-01-28	C162847	48780-1	d6a99b39-3e4b-a426-e053-dadaa90af4c2	BLACK

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43406-0135-2	BLACK	56.7 g in 1 BOTTLE, PUMP	GEL	56.7		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43406-0135	BLACK (ECHINACEA ANG., HYDRASTIS, PHYTOLACCA, PLANTAGO, STELLARIA MED., SYMPHYTUM, TRIFOLIUM PRAT., VERBASCUM, ARSENICUM ALB., BUFO, LACHESIS, LYCOPODIUM, SEPIA, SILICEA, THUJA OCC.) GEL [NATURAL CREATIONS, INC]	1	Legacy NDC, 1 package rows	20200527_fc221651-5d94-46e9-966b-35918e8361fb.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZW3Z11D0JV	GOLDENSEAL		GOLDENSEAL
11E6VI8VEG	PHYTOLACCA AMERICANA ROOT		PHYTOLACCA AMERICANA ROOT
2H03479QVR	STELLARIA MEDIA		STELLARIA MEDIA
DG4F8T839X	COMFREY LEAF		COMFREY LEAF
4JS0838828	TRIFOLIUM PRATENSE FLOWER		TRIFOLIUM PRATENSE FLOWER
S7V92P67HO	ARSENIC TRIOXIDE	1327-53-3	ARSENIC TRIOXIDE
Q59QU6N72Q	BUFO BUFO CUTANEOUS GLAND		BUFO BUFO CUTANEOUS GLAND
VSW71SS07I	LACHESIS MUTA VENOM		LACHESIS MUTA VENOM
C88X29Y479	LYCOPODIUM CLAVATUM SPORE	8023-70-9	LYCOPODIUM CLAVATUM SPORE
QDL83WN8C2	SEPIA OFFICINALIS JUICE		SEPIA OFFICINALIS JUICE
ETJ7Z6XBU4	SILICON DIOXIDE	7631-86-9	SILICON DIOXIDE
1NT28V9397	THUJA OCCIDENTALIS LEAFY TWIG		THUJA OCCIDENTALIS LEAFY TWIG

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43406-0135-2	43406013502	56.7 g in 1 BOTTLE, PUMP (43406-0135-2)	56.7 g	2007-05-20	0000-00-00	No	No	Current