D-112

Product NDC
58264-0118
Requested package NDC
58264-0118-1
11-digit product format
582640118
Labeler code
58264
Product ID
58264-0118_2b9eda10-4e9d-e31e-e063-6394a90a53c6
Type
HUMAN OTC DRUG
Nonproprietary name
Lachesis Muta venom, Silicon dioxide, Sodium chloride, Ranunculus bulbosus, Aconitum napellus, Activated charcoal, Nitroglycerin, Oyster shell calcium carbonate, crude, Anemone pratensis, Plantago major, arsenic trioxide, and Magnesium phosphate, dibasic trihydrate
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
ACONITUM NAPELLUS; ACTIVATED CHARCOAL; ANEMONE PRATENSIS; ARSENIC TRIOXIDE; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; NITROGLYCERIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PLANTAGO MAJOR; RANUNCULUS BULBOSUS; SILICON DIOXIDE; SODIUM CHLORIDE
Active strength
4; 8; 4; 6; 12; 4; 6; 8; 4; 4; 8; 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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Nitrate Vasodilator [EPC], Nitrates [CS], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vasodilation [PE]
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 dateCodeStatusSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

Additional Listing Data#

Finished product
Yes
Brand name base
D-112
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LACHESIS MUTA VENOM4 [hp_X]/mL
SILICON DIOXIDE8 [hp_X]/mL
SODIUM CHLORIDE4 [hp_X]/mL
RANUNCULUS BULBOSUS6 [hp_X]/mL
ACONITUM NAPELLUS12 [hp_X]/mL
ACTIVATED CHARCOAL4 [hp_X]/mL
NITROGLYCERIN6 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE8 [hp_X]/mL
ANEMONE PRATENSIS4 [hp_X]/mL
PLANTAGO MAJOR4 [hp_X]/mL
ARSENIC TRIOXIDE8 [hp_X]/mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE4 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VSW71SS07IInternal UNII lookup
ETJ7Z6XBU4Internal UNII lookup
451W47IQ8XInternal UNII lookup
AEQ8NXJ0MBInternal UNII lookup
U0NQ8555JDInternal UNII lookup
2P3VWU3H10Internal UNII lookup
G59M7S0WS3Internal UNII lookup
2E32821G6IInternal UNII lookup
8E272251DIInternal UNII lookup
W2469WNO6UInternal UNII lookup
S7V92P67HOInternal UNII lookup
HF539G9L3QInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8d517ef2-3a1e-4393-9452-a4cd0f0a3bcaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
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86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0118-12022-06-06C16284748780-19d75b9d0-36c1-f424-e053-dadaa90a57ceD-112
58264-0118-12020-01-31C16284748780-19d75b9d0-36c1-f424-e053-dadaa90a57ceD-112

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0118-1D-11229.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0118D-112 (LACHESIS MUTA VENOM, SILICON DIOXIDE, SODIUM CHLORIDE, RANUNCULUS BULBOSUS, ACONITUM NAPELLUS, ACTIVATED CHARCOAL, NITROGLYCERIN, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ANEMONE PRATENSIS, PLANTAGO MAJOR, ARSENIC TRIOXIDE, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_8d517ef2-3a1e-4393-9452-a4cd0f0a3bca.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-112LACHESIS MUTA VENOM, SILICON DIOXIDE, SODIUM CHLORIDE, RANUNCULUS BULBOSUS, ACONITUM NAPELLUS, ACTIVATED CHARCOAL, NITROGLYCERIN, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ANEMONE PRATENSIS, PLANTAGO MAJOR, ARSENIC TRIOXIDE, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEDNA Labs, Inc.8d517ef2-3a1e-4393-9452-a4cd0f0a3bca2025-01-13WarningsExact identifier
ndc (package): 58264-0118-1
ndc (product): 58264-0118
ndc11 (package): 58264011801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0118-15826401180129.57 mL in 1 BOTTLE, GLASS (58264-0118-1) 29.57 ml1990-01-010000-00-00NoNoCurrent