A-25

Product NDC
58264-0317
11-digit product format
582640317
Labeler code
58264
Product ID
58264-0317_2b50cfc6-9dea-6371-e063-6294a90a7de4
Type
HUMAN OTC DRUG
Nonproprietary name
GRINDELIA CILIATA POLLEN, DYSPHANIA BOTRYS POLLEN, XANTHIUM STRUMARIUM POLLEN, LEUCANTHEMUM VULGARE POLLEN, TARAXACUM OFFICINALE POLLEN, LONICERA JAPONICA FLOWER, IVA ANNUA POLLEN, ARTEMISIA VULGARIS POLLEN, and AMARANTHUS RETROFLEXUS POLLEN
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
GRINDELIA CILIATA POLLEN; DYSPHANIA BOTRYS POLLEN; XANTHIUM STRUMARIUM POLLEN; LEUCANTHEMUM VULGARE POLLEN; TARAXACUM OFFICINALE POLLEN; LONICERA JAPONICA FLOWER; IVA ANNUA POLLEN; ARTEMISIA VULGARIS POLLEN; AMARANTHUS RETROFLEXUS POLLEN
Active strength
30; 30; 30; 30; 30; 30; 30; 30; 30 [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], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS]
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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage58264-0317-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage58264-0317-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage58264-0317-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage58264-0317-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage58264-0317-19bebd1f3094a…5416666fcb17…

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
A-25
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GRINDELIA CILIATA POLLEN30 [hp_X]/mL
DYSPHANIA BOTRYS POLLEN30 [hp_X]/mL
XANTHIUM STRUMARIUM POLLEN30 [hp_X]/mL
LEUCANTHEMUM VULGARE POLLEN30 [hp_X]/mL
TARAXACUM OFFICINALE POLLEN30 [hp_X]/mL
LONICERA JAPONICA FLOWER30 [hp_X]/mL
IVA ANNUA POLLEN30 [hp_X]/mL
ARTEMISIA VULGARIS POLLEN30 [hp_X]/mL
AMARANTHUS RETROFLEXUS POLLEN30 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9S54D5MCPFInternal UNII lookup
IVU789297DInternal UNII lookup
2QOF601J1MInternal UNII lookup
H9E0IX4MOXInternal UNII lookup
WQ3S5294XYInternal UNII lookup
4465L2WS4YInternal UNII lookup
Y2U5S5PF22Internal UNII lookup
ANT994T71DInternal UNII lookup
73B14PX5FWInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
943b766b-2f73-4659-928e-e2b4b1027a7fAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0317-12022-05-30C16284748780-19d75b9d0-d4aa-f424-e053-dadaa90a57ceA-25
58264-0317-12020-01-31C16284748780-19d75b9d0-d4aa-f424-e053-dadaa90a57ceA-25

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0317-1A-2529.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0317A-25 (GRINDELIA CILIATA POLLEN, DYSPHANIA BOTRYS POLLEN, XANTHIUM STRUMARIUM POLLEN, LEUCANTHEMUM VULGARE POLLEN, TARAXACUM OFFICINALE POLLEN, LONICERA JAPONICA FLOWER, IVA ANNUA POLLEN, ARTEMISIA VULGARIS POLLEN, AND AMARANTHUS RETROFLEXUS POLLEN) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_943b766b-2f73-4659-928e-e2b4b1027a7f.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
A-25GRINDELIA CILIATA POLLEN, DYSPHANIA BOTRYS POLLEN, XANTHIUM STRUMARIUM POLLEN, LEUCANTHEMUM VULGARE POLLEN, TARAXACUM OFFICINALE POLLEN, LONICERA JAPONICA FLOWER, IVA ANNUA POLLEN, ARTEMISIA VULGARIS POLLEN, AND AMARANTHUS RETROFLEXUS POLLENDNA Labs, Inc.943b766b-2f73-4659-928e-e2b4b1027a7f2025-01-09WarningsExact identifier
ndc (product): 58264-0317

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0317-15826403170129.57 mL in 1 BOTTLE, GLASS (58264-0317-1) 29.57 ml1990-01-010000-00-00NoNoCurrent