Home NDC 58264-0112-1 D-106
Product NDC 58264-0112
Requested package NDC 58264-0112-1
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 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…
Additional Listing Data#
Finished product Yes
Brand name base D-106
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BETAINE HYDROCHLORIDE 6 [hp_X]/mL BOS TAURUS BILE 3 [hp_X]/mL PANCRELIPASE LIPASE 6 [hp_X]/mL BEEF LIVER 6 [hp_X]/mL SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 3 [hp_X]/mL BOS TAURUS PANCREAS 3 [hp_X]/mL PEPSIN 3 [hp_X]/mL SUS SCROFA STOMACH 6 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 8 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58264-0112-1 D-106 29.57 mL in 1 BOTTLE, GLASS SOLUTION 29.57 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58264-0112 D-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.] 3 Current NDC, Legacy NDC, 1 package rows 20250115_c032c034-c58b-4287-b78c-37fab1feb425.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-106 BETAINE HYDROCHLORIDE, BOS TAURUS BILE, PANCRELIPASE LIPASE, BEEF LIVER, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, BOS TAURUS PANCREAS, PEPSIN, AND SUS SCROFA STOMACH DNA Labs, Inc. c032c034-c58b-4287-b78c-37fab1feb425 2025-01-13 Warnings Exact identifier ndc (package): 58264-0112-1 ndc (product): 58264-0112 ndc11 (package): 58264011201
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58264-0112-1 58264011201 29.57 mL in 1 BOTTLE, GLASS (58264-0112-1) 29.57 ml 1990-01-01 0000-00-00 No No Current