Home NDC 58264-0347 AM-8
Product NDC 58264-0347
11-digit product format 582640347
Labeler code 58264
Product ID 58264-0347_2b52dd9d-5def-a801-e063-6294a90aeffa
Type HUMAN OTC DRUG
Nonproprietary name Atropa belladonna, Calcium Sulfate Anhydrous, and Formica rufa
Dosage form SOLUTION
Route SUBLINGUAL
Labeler DNA Labs, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 1990-01-01
Substance ATROPA BELLADONNA; CALCIUM SULFATE ANHYDROUS; FORMICA RUFA
Active strength 8; 8; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 58264-0347-1 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 58264-0347-1 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 58264-0347-1 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 58264-0347-1 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 58264-0347-1 9bebd1f3094a…5416666fcb17…
Additional Listing Data#
Finished product Yes
Brand name base AM-8
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATROPA BELLADONNA 8 [hp_X]/mL CALCIUM SULFATE ANHYDROUS 8 [hp_X]/mL FORMICA RUFA 12 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WQZ3G9PF0H Internal UNII lookup E934B3V59H Internal UNII lookup 55H0W83JO5 Internal UNII lookup
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 58264-0347-1 AM-8 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 58264-0347 AM-8 (ATROPA BELLADONNA, CALCIUM SULFATE ANHYDROUS, AND FORMICA RUFA) SOLUTION [DNA LABS, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20250112_c313d3e3-11a2-45f7-8b87-1bf5d1019137.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 AM-8 ATROPA BELLADONNA, CALCIUM SULFATE ANHYDROUS, AND FORMICA RUFA DNA Labs, Inc. c313d3e3-11a2-45f7-8b87-1bf5d1019137 2025-01-09 Warnings Exact identifier ndc (product): 58264-0347
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58264-0347-1 58264034701 29.57 mL in 1 BOTTLE, GLASS (58264-0347-1) 29.57 ml 1990-01-01 0000-00-00 No No Current