D-106

Product NDC
58264-0112
11-digit product format
582640112
Labeler code
58264
Product ID
58264-0112_2b9eda10-4e9c-e31e-e063-6394a90a53c6
Type
HUMAN OTC DRUG
Nonproprietary name
betaine hydrochloride, bos taurus bile, pancrelipase lipase, beef liver, sodium phosphate, dibasic, heptahydrate, bos taurus pancreas, pepsin, and sus scrofa stomach
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
BEEF LIVER; BETAINE HYDROCHLORIDE; BOS TAURUS BILE; BOS TAURUS PANCREAS; PANCRELIPASE LIPASE; PEPSIN; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SUS SCROFA STOMACH
Active strength
6; 3; 6; 6; 3; 3; 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
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Meat Proteins [EXT], Methylating Activity [MoA], Methylating Agent [EPC], Non-Standardized Food Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
D-106
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BEEF LIVER6 [hp_X]/mL
BETAINE HYDROCHLORIDE3 [hp_X]/mL
BOS TAURUS BILE6 [hp_X]/mL
BOS TAURUS PANCREAS6 [hp_X]/mL
PANCRELIPASE LIPASE3 [hp_X]/mL
PEPSIN3 [hp_X]/mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE3 [hp_X]/mL
SUS SCROFA STOMACH6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW8N8R55022, JK8U8K4D6K, ET3651ZLOU, 1M529TNT1D, 8MYC33932O, GID333S43J, 70WT22SF4B, T0920P9Z9A

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
0b1603b8-969e-b082-f6f5-ad66d8a6ea8aProduct name220200325
19041f15-771b-3d3a-88fc-f5e2d079cd6dProduct name220200325
1987d950-08e4-4b70-adeb-fb67a71142abProduct name220200325
8825ddf7-1520-4680-b0ee-684e2fa73672Product name220200325
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
267a6f34-90b4-2f48-3063-4f505d06a7beProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0112-12022-06-06C16284748780-19d75b9cf-defe-f424-e053-dadaa90a57ceD-106
58264-0112-12020-01-31C16284748780-19d75b9cf-defe-f424-e053-dadaa90a57ceD-106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0112-1D-10629.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0112D-106 (BETAINE HYDROCHLORIDE, BOS TAURUS BILE, PANCRELIPASE LIPASE, BEEF LIVER, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, BOS TAURUS PANCREAS, PEPSIN, AND SUS SCROFA STOMACH) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_c032c034-c58b-4287-b78c-37fab1feb425.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0112-15826401120129.57 mL in 1 BOTTLE, GLASS (58264-0112-1) 29.57 ml1990-01-010000-00-00NoNoCurrent