Home NDC 58264-0139 D-133
Product NDC 58264-0139
11-digit product format 582640139
Labeler code 58264
Product ID 58264-0139_2b9efed7-5d8a-16bd-e063-6394a90ac14f
Type HUMAN OTC DRUG
Nonproprietary name Calcium fluoride, Silicon dioxide, Tribasic calcium phosphate, Calcium sulfate anhydrous, Ferrosoferric phosphate, Potassium chloride, Dibasic potassium phosphate, Potassium sulfate, Magnesium phosphate, dibasic trihydrate, Sodium phosphate, dibasic, heptahydrate, Sodium chloride, and Sodium sulfate
Dosage form SOLUTION
Route SUBLINGUAL
Labeler DNA Labs, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 1990-01-01
Substance CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; DIBASIC POTASSIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE
Active strength 8; 6; 6; 6; 6; 6; 6; 8; 6; 6; 6; 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
Pharmacologic classes Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58264-0139-1 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 58264-0139-1 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 58264-0139-1 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 58264-0139-1 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 58264-0139-1 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 58264-0139-1 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Additional Listing Data#
Finished product Yes
Brand name base D-133
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM FLUORIDE 8 [hp_X]/mL SILICON DIOXIDE 6 [hp_X]/mL TRIBASIC CALCIUM PHOSPHATE 6 [hp_X]/mL CALCIUM SULFATE ANHYDROUS 6 [hp_X]/mL FERROSOFERRIC PHOSPHATE 6 [hp_X]/mL POTASSIUM CHLORIDE 6 [hp_X]/mL DIBASIC POTASSIUM PHOSPHATE 6 [hp_X]/mL POTASSIUM SULFATE 8 [hp_X]/mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_X]/mL SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 6 [hp_X]/mL SODIUM CHLORIDE 6 [hp_X]/mL SODIUM SULFATE 6 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 12 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 58264-0139-1 D-133 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 58264-0139 D-133 (CALCIUM FLUORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM CHLORIDE, AND SODIUM SULFATE) SOLUTION [DNA LABS, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20250115_a250b7e9-7fd2-4cb0-82f3-baa089d17441.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-133 CALCIUM FLUORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM CHLORIDE, AND SODIUM SULFATE DNA Labs, Inc. a250b7e9-7fd2-4cb0-82f3-baa089d17441 2025-01-13 Warnings Exact identifier ndc (product): 58264-0139
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58264-0139-1 58264013901 29.57 mL in 1 BOTTLE, GLASS (58264-0139-1) 29.57 ml 1990-01-01 0000-00-00 No No Current