FDA.reportPublic FDA data

D-97

Product NDC
58264-0103
11-digit product format
582640103
Labeler code
58264
Product ID
58264-0103_2b9ed994-a885-0e65-e063-6394a90aca84
Type
HUMAN OTC DRUG
Nonproprietary name
Aluminum oxide, Silver, Silver nitrate, Arsenic trioxide, Mercurius solubilis, Calomel, Mercuric iodide, Lead, Lead iodide, Chelidonium majus, Zinc, Solidago virgaurea flowering top, and Citric acid monohydrate
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
ALUMINUM OXIDE; ARSENIC TRIOXIDE; CALOMEL; CHELIDONIUM MAJUS; CITRIC ACID MONOHYDRATE; LEAD; LEAD IODIDE; MERCURIC IODIDE; MERCURIUS SOLUBILIS; SILVER; SILVER NITRATE; SOLIDAGO VIRGAUREA FLOWERING TOP; ZINC
Active strength
14; 14; 14; 3; 2; 14; 14; 14; 14; 14; 14; 3; 6 [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; [hp_X]/mL
Pharmacologic classes
Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
D-97
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM OXIDE14 [hp_X]/mL
ARSENIC TRIOXIDE14 [hp_X]/mL
CALOMEL14 [hp_X]/mL
CHELIDONIUM MAJUS3 [hp_X]/mL
CITRIC ACID MONOHYDRATE2 [hp_X]/mL
LEAD14 [hp_X]/mL
LEAD IODIDE14 [hp_X]/mL
MERCURIC IODIDE14 [hp_X]/mL
MERCURIUS SOLUBILIS14 [hp_X]/mL
SILVER14 [hp_X]/mL
SILVER NITRATE14 [hp_X]/mL
SOLIDAGO VIRGAUREA FLOWERING TOP3 [hp_X]/mL
ZINC6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLMI26O6933, S7V92P67HO, J2D46N657D, 7E889U5RNN, 2968PHW8QP, 2P299V784P, OTL90F2GLT, R03O05RB0P, 324Y4038G2, 3M4G523W1G, 95IT3W8JZE, 5405K23S50, J41CSQ7QDS

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0103-12022-06-06C16284748780-19d75b9d0-e62f-f424-e053-dadaa90a57ceD-97
58264-0103-12020-01-31C16284748780-19d75b9d0-e62f-f424-e053-dadaa90a57ceD-97

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0103-1D-9729.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0103D-97 (ALUMINUM OXIDE, SILVER, SILVER NITRATE, ARSENIC TRIOXIDE, MERCURIUS SOLUBILIS, CALOMEL, MERCURIC IODIDE, LEAD, LEAD IODIDE, CHELIDONIUM MAJUS, ZINC, SOLIDAGO VIRGAUREA FLOWERING TOP, AND CITRIC ACID MONOHYDRATE) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_b2079abb-786c-4f92-8d49-5606c77f7d72.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0103-15826401030129.57 mL in 1 BOTTLE, GLASS (58264-0103-1) 29.57 ml1990-01-010000-00-00NoNoCurrent