N-22

Product NDC
58264-0230
Requested package NDC
58264-0230-1
11-digit product format
582640230
Labeler code
58264
Product ID
58264-0230_f0ffc043-bfe4-5986-e053-2995a90a7ec1
Type
HUMAN OTC DRUG
Nonproprietary name
APIS MELLIFERA, PILOCARPUS MICROPHYLLUS LEAF, TRIFOLIUM REPENS WHOLE, ATROPA BELLADONNA, BARIUM CARBONATE, FERROSOFERRIC PHOSPHATE, POTASSIUM DICHROMATE, PHYTOLACCA AMERICANA WHOLE, ANEMONE PULSATILLA, MERCURIUS SOLUBILIS and BOS TAURUS PAROTID GLAND
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Marketing end
0000-00-00
Substance
ANEMONE PULSATILLA; APIS MELLIFERA; ATROPA BELLADONNA; BARIUM CARBONATE; BOS TAURUS PAROTID GLAND; FERROSOFERRIC PHOSPHATE; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA WHOLE; PILOCARPUS MICROPHYLLUS LEAF; POTASSIUM DICHROMATE; TRIFOLIUM REPENS WHOLE
Active strength
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
Pharmacologic classes
Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58264-023058264-0230-1IInactivated by FDA2026-10-05

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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0230-12025-01-30C16284748780-12cef2736-812b-d83d-e063-dadaa90ab31fN-22

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0230-1N-2229.57 mL in 1 BOTTLE, GLASSSOLUTION29.571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0230N-22 (APIS MELLIFERA, PILOCARPUS MICROPHYLLUS LEAF, TRIFOLIUM REPENS WHOLE, ATROPA BELLADONNA, BARIUM CARBONATE, FERROSOFERRIC PHOSPHATE, POTASSIUM DICHROMATE, PHYTOLACCA AMERICANA WHOLE, ANEMONE PULSATILLA, MERCURIUS SOLUBILIS AND BOS TAURUS PAROTID GLAND) SOLUTION [DNA LABS, INC.]1Legacy NDC, 1 package rows20230101_f0ffc043-bfe3-5986-e053-2995a90a7ec1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0230-15826402300129.57 mL in 1 BOTTLE, GLASS (58264-0230-1) 29.57 ml1990-01-010000-00-00NoNoCurrent