Home NDC 58264-0082 D81
Product NDC 58264-0082
11-digit product format 582640082
Labeler code 58264
Product ID 58264-0082_2b9ed194-def4-363e-e063-6294a90a8cdc
Type HUMAN OTC DRUG
Nonproprietary name PASSIFLORA INCARNATA WHOLE, SMILAX ORNATA WHOLE, PHYTOLACCA AMERICANA ROOT, STILLINGIA SYLVATICA ROOT, TRIFOLIUM PRATENSE WHOLE, ARCTIUM LAPPA WHOLE, PRUNUS DULCIS WHOLE, FRANGULA PURSHIANA BARK, BERBERIS VULGARIS WHOLE, GLYCYRRHIZA GLABRA WHOLE, and LARREA DIVARICATA WHOLE
Dosage form SOLUTION
Route SUBLINGUAL
Labeler DNA Labs, Inc.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 1990-01-01
Substance ARCTIUM LAPPA WHOLE; BERBERIS VULGARIS WHOLE; FRANGULA PURSHIANA BARK; GLYCYRRHIZA GLABRA WHOLE; LARREA DIVARICATA WHOLE; PASSIFLORA INCARNATA WHOLE; PHYTOLACCA AMERICANA ROOT; PRUNUS DULCIS WHOLE; SMILAX ORNATA WHOLE; STILLINGIA SYLVATICA ROOT; TRIFOLIUM PRATENSE WHOLE
Active strength 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1 [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
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 58264-0082-1 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 58264-0082-1 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 58264-0082-1 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 58264-0082-1 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 58264-0082-1 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 58264-0082-1 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Additional Listing Data#
Finished product Yes
Brand name base D81
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PASSIFLORA INCARNATA WHOLE 1 [hp_X]/mL SMILAX ORNATA WHOLE 1 [hp_X]/mL PHYTOLACCA AMERICANA ROOT 1 [hp_X]/mL STILLINGIA SYLVATICA ROOT 1 [hp_X]/mL TRIFOLIUM PRATENSE WHOLE 1 [hp_X]/mL ARCTIUM LAPPA WHOLE 1 [hp_X]/mL PRUNUS DULCIS WHOLE 1 [hp_X]/mL FRANGULA PURSHIANA BARK 1 [hp_X]/mL BERBERIS VULGARIS WHOLE 1 [hp_X]/mL GLYCYRRHIZA GLABRA WHOLE 1 [hp_X]/mL LARREA DIVARICATA WHOLE 1 [hp_X]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 11 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58264-0082-1 D81 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 58264-0082 D81 (PASSIFLORA INCARNATA WHOLE, SMILAX ORNATA WHOLE, PHYTOLACCA AMERICANA ROOT, STILLINGIA SYLVATICA ROOT, TRIFOLIUM PRATENSE WHOLE, ARCTIUM LAPPA WHOLE, PRUNUS DULCIS WHOLE, FRANGULA PURSHIANA BARK, BERBERIS VULGARIS WHOLE, GLYCYRRHIZA GLABRA WHOLE, AND LARREA DIVARICATA WHOLE) SOLUTION [DNA LABS, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20250115_42bffb7a-ca76-4cbb-b5c9-b677e93b6d31.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 D81 PASSIFLORA INCARNATA WHOLE, SMILAX ORNATA WHOLE, PHYTOLACCA AMERICANA ROOT, STILLINGIA SYLVATICA ROOT, TRIFOLIUM PRATENSE WHOLE, ARCTIUM LAPPA WHOLE, PRUNUS DULCIS WHOLE, FRANGULA PURSHIANA BARK, BERBERIS VULGARIS WHOLE, GLYCYRRHIZA GLABRA WHOLE, AND LARREA DIVARICATA WHOLE DNA Labs, Inc. 42bffb7a-ca76-4cbb-b5c9-b677e93b6d31 2025-01-13 Warnings Exact identifier ndc (product): 58264-0082
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58264-0082-1 58264008201 29.57 mL in 1 BOTTLE, GLASS (58264-0082-1) 29.57 ml 1990-01-01 0000-00-00 No No Current