D-8

Product NDC: 58264-0008
Requested package NDC: 58264-0008-1
11-digit product format: 582640008
Labeler code: 58264
Product ID: 58264-0008_2b9ea1fc-59a5-8189-e063-6394a90a9ae6
Type: HUMAN OTC DRUG
Nonproprietary name: SPONGIA OFFICINALIS SKELETON, ROASTED, CAUSTICUM, LACHESIS MUTA VENOM, CALCIUM SULFIDE, THYMUS SERPYLLUM, ANTIMONY POTASSIUM TARTRATE, ACONITUM NAPELLUS, AND DROSERA ROTUNDIFOLIA
Dosage form: SOLUTION
Route: SUBLINGUAL
Labeler: DNA Labs, Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 1990-01-01
Substance: SPONGIA OFFICINALIS SKELETON, ROASTED; CAUSTICUM; LACHESIS MUTA VENOM; CALCIUM SULFIDE; THYMUS SERPYLLUM; ANTIMONY POTASSIUM TARTRATE; ACONITUM NAPELLUS; DROSERA ROTUNDIFOLIA
Active strength: 4; 6; 8; 5; 3; 6; 6; 4 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
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 · 6 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`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: D-8
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SPONGIA OFFICINALIS SKELETON, ROASTED	4 [hp_X]/mL
CAUSTICUM	6 [hp_X]/mL
LACHESIS MUTA VENOM	8 [hp_X]/mL
CALCIUM SULFIDE	5 [hp_X]/mL
THYMUS SERPYLLUM	3 [hp_X]/mL
ANTIMONY POTASSIUM TARTRATE	6 [hp_X]/mL
ACONITUM NAPELLUS	6 [hp_X]/mL
DROSERA ROTUNDIFOLIA	4 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1PIP394IID	Internal UNII lookup
DD5FO1WKFU	Internal UNII lookup
VSW71SS07I	Internal UNII lookup
1MBW07J51Q	Internal UNII lookup
86H4S6K51N	Internal UNII lookup
DL6OZ476V3	Internal UNII lookup
U0NQ8555JD	Internal UNII lookup
QR44N9XPJQ	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
bc817ccf-f11c-4875-9e14-5a249f92c503	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58264-0008-1	2022-06-02	C162847	48780-1	9d75b9d1-013e-f424-e053-dadaa90a57ce	D-8
58264-0008-1	2020-01-31	C162847	48780-1	9d75b9d1-013e-f424-e053-dadaa90a57ce	D-8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58264-0008-1	D-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
58264-0008	D-8 (SPONGIA OFFICINALIS SKELETON, ROASTED, CAUSTICUM, LACHESIS MUTA VENOM, CALCIUM SULFIDE, THYMUS SERPYLLUM, ANTIMONY POTASSIUM TARTRATE, ACONITUM NAPELLUS, AND DROSERA ROTUNDIFOLIA) SOLUTION [DNA LABS, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20250115_bc817ccf-f11c-4875-9e14-5a249f92c503.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
D-8	SPONGIA OFFICINALIS SKELETON, ROASTED, CAUSTICUM, LACHESIS MUTA VENOM, CALCIUM SULFIDE, THYMUS SERPYLLUM, ANTIMONY POTASSIUM TARTRATE, ACONITUM NAPELLUS, AND DROSERA ROTUNDIFOLIA	DNA Labs, Inc.	bc817ccf-f11c-4875-9e14-5a249f92c503	2025-01-13	Warnings	Exact identifier ndc (package): 58264-0008-1 ndc (product): 58264-0008 ndc11 (package): 58264000801

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1PIP394IID	SPONGIA OFFICINALIS SKELETON, ROASTED		SPONGIA OFFICINALIS SKELETON, ROASTED
DD5FO1WKFU	CAUSTICUM		CAUSTICUM
VSW71SS07I	LACHESIS MUTA VENOM		LACHESIS MUTA VENOM
1MBW07J51Q	CALCIUM SULFIDE	20548-54-3	CALCIUM SULFIDE
86H4S6K51N	THYMUS SERPYLLUM		THYMUS SERPYLLUM
DL6OZ476V3	ANTIMONY POTASSIUM TARTRATE	28300-74-5	ANTIMONY POTASSIUM TARTRATE
U0NQ8555JD	ACONITUM NAPELLUS		ACONITUM NAPELLUS
QR44N9XPJQ	DROSERA ROTUNDIFOLIA		DROSERA ROTUNDIFOLIA

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58264-0008-1	58264000801	29.57 mL in 1 BOTTLE, GLASS (58264-0008-1)	29.57 ml	1990-01-01	0000-00-00	No	No	Current

D-8