Home NDC 58264-0164-1 D-153
Product NDC 58264-0164
Requested package NDC 58264-0164-1
11-digit product format 582640164
Labeler code 58264
Product ID 58264-0164_2b9f0ea7-160f-1707-e063-6394a90a3c44
Type HUMAN OTC DRUG
Nonproprietary name Juglans regia leaf, Lachesis, Calcarea carbonica, Lycopodium, Phosphorus, Magnesium Phosphate
Dosage form SOLUTION
Route SUBLINGUAL
Labeler DNA Labs
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2023-02-11
Substance OYSTER SHELL CALCIUM CARBONATE, CRUDE; JUGLANS REGIA LEAF; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
Active strength 30; 1; 30; 30; 12; 6 [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], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58264-0164 58264-0164-1 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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-153
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OYSTER SHELL CALCIUM CARBONATE, CRUDE 30 [hp_X]/mL JUGLANS REGIA LEAF 1 [hp_X]/mL LACHESIS MUTA VENOM 30 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE 30 [hp_X]/mL PHOSPHORUS 12 [hp_X]/mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 6 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58264-0164-1 D-153 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 58264-0164 D-153 (JUGLANS REGIA LEAF, LACHESIS, CALCAREA CARBONICA, LYCOPODIUM, PHOSPHORUS, MAGNESIUM PHOSPHATE) SOLUTION [DNA LABS] 4 Current NDC, 1 package rows 20250115_f473b88f-527c-46be-e053-2995a90a7300.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58264-0164-1 58264016401 29.57 mL in 1 BOTTLE, GLASS (58264-0164-1) 29.57 ml 2023-02-11 No No Current