N-8

Product NDC: 58264-0206
Requested package NDC: 58264-0206-1
11-digit product format: 582640206
Labeler code: 58264
Product ID: 58264-0206_2b535a39-0bac-b8c0-e063-6394a90a80d3
Type: HUMAN OTC DRUG
Nonproprietary name: SILICON DIOXIDE, ATROPA BELLADONNA, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, PALLADIUM, APIS MELLIFERA, and BOS TAURUS OVARY
Dosage form: SOLUTION
Route: SUBLINGUAL
Labeler: DNA Labs, Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 1990-01-01
Substance: SILICON DIOXIDE; ATROPA BELLADONNA; CITRULLUS COLOCYNTHIS FRUIT PULP; BLACK COHOSH; ANEMONE PULSATILLA; SEPIA OFFICINALIS JUICE; PALLADIUM; APIS MELLIFERA; BOS TAURUS OVARY
Active strength: 6; 6; 6; 6; 6; 10; 10; 6; 200 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes: Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 5 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
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	`9bebd1f3094a…`	`5416666fcb17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: N-8
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SILICON DIOXIDE	6 [hp_X]/mL
ATROPA BELLADONNA	6 [hp_X]/mL
CITRULLUS COLOCYNTHIS FRUIT PULP	6 [hp_X]/mL
BLACK COHOSH	6 [hp_X]/mL
ANEMONE PULSATILLA	6 [hp_X]/mL
SEPIA OFFICINALIS JUICE	10 [hp_X]/mL
PALLADIUM	10 [hp_X]/mL
APIS MELLIFERA	6 [hp_X]/mL
BOS TAURUS OVARY	200 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ETJ7Z6XBU4	Internal UNII lookup
WQZ3G9PF0H	Internal UNII lookup
23H32AOH17	Internal UNII lookup
K73E24S6X9	Internal UNII lookup
I76KB35JEV	Internal UNII lookup
QDL83WN8C2	Internal UNII lookup
5TWQ1V240M	Internal UNII lookup
7S82P3R43Z	Internal UNII lookup
66LZN1C747	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c25cdcb5-9469-48bb-b216-0a9d8d644e12	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58264-0206-1	2022-06-06	C162847	48780-1	9d75b9d0-c172-f424-e053-dadaa90a57ce	N-8
58264-0206-1	2020-01-31	C162847	48780-1	9d75b9d0-c172-f424-e053-dadaa90a57ce	N-8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58264-0206-1	N-8	29.57 mL in 1 BOTTLE, GLASS	SOLUTION	29.57		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58264-0206	N-8 (SILICON DIOXIDE, ATROPA BELLADONNA, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, PALLADIUM, APIS MELLIFERA, AND BOS TAURUS OVARY) SOLUTION [DNA LABS, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20250112_c25cdcb5-9469-48bb-b216-0a9d8d644e12.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
N-8	SILICON DIOXIDE, ATROPA BELLADONNA, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, PALLADIUM, APIS MELLIFERA, AND BOS TAURUS OVARY	DNA Labs, Inc.	c25cdcb5-9469-48bb-b216-0a9d8d644e12	2025-01-09	Warnings	Exact identifier ndc (package): 58264-0206-1 ndc (product): 58264-0206 ndc11 (package): 58264020601

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ETJ7Z6XBU4	SILICON DIOXIDE	7631-86-9	SILICON DIOXIDE
WQZ3G9PF0H	ATROPA BELLADONNA		ATROPA BELLADONNA
23H32AOH17	CITRULLUS COLOCYNTHIS FRUIT PULP		CITRULLUS COLOCYNTHIS FRUIT PULP
K73E24S6X9	BLACK COHOSH		BLACK COHOSH
I76KB35JEV	ANEMONE PULSATILLA		ANEMONE PULSATILLA
QDL83WN8C2	SEPIA OFFICINALIS JUICE		SEPIA OFFICINALIS JUICE
5TWQ1V240M	PALLADIUM	7440-05-3	PALLADIUM
7S82P3R43Z	APIS MELLIFERA		APIS MELLIFERA
66LZN1C747	BOS TAURUS OVARY		BOS TAURUS OVARY

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58264-0206-1	58264020601	29.57 mL in 1 BOTTLE, GLASS (58264-0206-1)	29.57 ml	1990-01-01	0000-00-00	No	No	Current

N-8