A-12

Product NDC
58264-0304
11-digit product format
582640304
Labeler code
58264
Product ID
58264-0304_2b4dc104-39fd-f11c-e063-6294a90ad1db
Type
HUMAN OTC DRUG
Nonproprietary name
JUNIPERUS ASHEI POLLEN, JUNIPERUS VIRGINIANA POLLEN, TAMARIX GALLICA POLLEN, CUPRESSUS ARIZONICA POLLEN, TAXODIUM DISTICHUM POLLEN, JUNIPERUS MONOSPERMA POLLEN, JUNIPERUS PINCHOTII POLLEN, JUNIPERUS SCOPULORUM POLLEN, PINUS TAEDA POLLEN, PINUS STROBUS POLLEN, and PINUS ECHINATA POLLEN
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
CUPRESSUS ARIZONICA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS MONOSPERMA POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; PINUS ECHINATA POLLEN; PINUS STROBUS POLLEN; PINUS TAEDA POLLEN; TAMARIX GALLICA POLLEN; TAXODIUM DISTICHUM POLLEN
Active strength
30; 30; 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; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], 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], 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 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], 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], 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], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
A-12
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CUPRESSUS ARIZONICA POLLEN30 [hp_X]/mL
JUNIPERUS ASHEI POLLEN30 [hp_X]/mL
JUNIPERUS MONOSPERMA POLLEN30 [hp_X]/mL
JUNIPERUS PINCHOTII POLLEN30 [hp_X]/mL
JUNIPERUS SCOPULORUM POLLEN30 [hp_X]/mL
JUNIPERUS VIRGINIANA POLLEN30 [hp_X]/mL
PINUS ECHINATA POLLEN30 [hp_X]/mL
PINUS STROBUS POLLEN30 [hp_X]/mL
PINUS TAEDA POLLEN30 [hp_X]/mL
TAMARIX GALLICA POLLEN30 [hp_X]/mL
TAXODIUM DISTICHUM POLLEN30 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii232DMH0XVF, 544F8MEY0Y, PM6E3FG1QK, S8A4X05W7J, 0G82TT8ZFY, PY0JA16R2G, 96LRW14765, TX1ER5UV3T, 4O1FFR8ARN, 43IR7KR479, O12H03B41R

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0304-12022-05-30C16284748780-19d75b9d0-5170-f424-e053-dadaa90a57ceA-12
58264-0304-12020-01-31C16284748780-19d75b9d0-5170-f424-e053-dadaa90a57ceA-12

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0304-1A-1229.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0304A-12 (JUNIPERUS ASHEI POLLEN, JUNIPERUS VIRGINIANA POLLEN, TAMARIX GALLICA POLLEN, CUPRESSUS ARIZONICA POLLEN, TAXODIUM DISTICHUM POLLEN, JUNIPERUS MONOSPERMA POLLEN, JUNIPERUS PINCHOTII POLLEN, JUNIPERUS SCOPULORUM POLLEN, PINUS TAEDA POLLEN, PINUS STROBUS POLLEN, AND PINUS ECHINATA POLLEN) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_fd7e5d2d-3c74-43bb-b8a1-e346a9a5b51d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0304-15826403040129.57 mL in 1 BOTTLE, GLASS (58264-0304-1) 29.57 ml1990-01-010000-00-00NoNoCurrent