FDA.reportPublic FDA data

Dandelion

Product NDC
22840-1501
11-digit product format
228401501
Labeler code
22840
Product ID
22840-1501_36abfd47-fc5d-43c4-e063-6394a90a8731
Type
NON-STANDARDIZED ALLERGENIC
Nonproprietary name
Taraxacum officinale
Dosage form
SOLUTION
Route
INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS
Labeler
Greer Laboratories, Inc.
Application
BLA101833
Marketing category
BLA
Marketing start
1981-09-15
Substance
TARAXACUM OFFICINALE POLLEN
Active strength
1000 [PNU]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], 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
Dandelion
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TARAXACUM OFFICINALE POLLEN1000 [PNU]/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
22840-1501-12021-05-27C16284748780-1ba0f9c33-21ee-a910-e053-dadaa90a0b85Non Standardized Allergenic Extracts Pollens, Molds, Epidermals, Insects, Dusts, Foods, and Miscellaneous Inhalants
22840-1501-12021-01-29C16284748780-1ba0f9c33-21ee-a910-e053-dadaa90a0b85Non Standardized Allergenic Extracts Pollens, Molds, Epidermals, Insects, Dusts, Foods, and Miscellaneous Inhalants

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
22840-1501-1Dandelion5 mL in 1 VIAL, MULTI-DOSESOLUTION59

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
22840-1501DAISY (LEUCANTHEMUM VULGARE) SOLUTION DANDELION (TARAXACUM OFFICINALE) SOLUTION SUNFLOWER (HELIANTHUS ANNUUS) SOLUTION [GREER LABORATORIES, INC.]8Current NDC, Legacy NDC, 1 package rows20241207_7a04fcbd-969d-7acd-e053-2991aa0a7a84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2102045dandelion pollen extract 1 MG/mL Injectable SolutionPSN7a04fcbd-969d-7acd-e053-2991aa0a7a849
1014002dandelion pollen extract 100 MG/ML Injectable SolutionPSN7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102047dandelion pollen extract 1000 UNT/mL Injectable SolutionPSN7a04fcbd-969d-7acd-e053-2991aa0a7a849
1013972dandelion pollen extract 20,000 UNT/mL Injectable SolutionPSN7a04fcbd-969d-7acd-e053-2991aa0a7a849
1013974dandelion pollen extract 40,000 UNT/mL Injectable SolutionPSN7a04fcbd-969d-7acd-e053-2991aa0a7a849
852082dandelion pollen extract 50 MG/ML Injectable SolutionPSN7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102012ox-eye daisy pollen extract 100 MG/mL Injectable SolutionPSN7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102014ox-eye daisy pollen extract 40,000 UNT/mL Injectable SolutionPSN7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102010ox-eye daisy pollen extract 50 MG/mL Injectable SolutionPSN7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102444sunflower pollen extract 1 MG/mL Injectable SolutionPSN7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102450sunflower pollen extract 100 MG/mL Injectable SolutionPSN7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102452sunflower pollen extract 1000 UNT/mL Injectable SolutionPSN7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102454sunflower pollen extract 40,000 UNT/mL Injectable SolutionPSN7a04fcbd-969d-7acd-e053-2991aa0a7a849
852512sunflower pollen extract 50 MG/ML Injectable SolutionPSN7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102045dandelion pollen extract 1 MG/ML Injectable SolutionSCD7a04fcbd-969d-7acd-e053-2991aa0a7a849
1014002dandelion pollen extract 100 MG/ML Injectable SolutionSCD7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102047dandelion pollen extract 1000 UNT/ML Injectable SolutionSCD7a04fcbd-969d-7acd-e053-2991aa0a7a849
1013972dandelion pollen extract 20000 UNT/ML Injectable SolutionSCD7a04fcbd-969d-7acd-e053-2991aa0a7a849
1013974dandelion pollen extract 40000 UNT/ML Injectable SolutionSCD7a04fcbd-969d-7acd-e053-2991aa0a7a849
852082dandelion pollen extract 50 MG/ML Injectable SolutionSCD7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102012Leucanthemum vulgare pollen 100 MG/ML Injectable SolutionSCD7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102014Leucanthemum vulgare pollen 40000 UNT/ML Injectable SolutionSCD7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102010Leucanthemum vulgare pollen 50 MG/ML Injectable SolutionSCD7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102444sunflower pollen extract 1 MG/ML Injectable SolutionSCD7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102450sunflower pollen extract 100 MG/ML Injectable SolutionSCD7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102452sunflower pollen extract 1000 UNT/ML Injectable SolutionSCD7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102454sunflower pollen extract 40000 UNT/ML Injectable SolutionSCD7a04fcbd-969d-7acd-e053-2991aa0a7a849
852512sunflower pollen extract 50 MG/ML Injectable SolutionSCD7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102444Helianthus annuus pollen extract 0.001 GM/ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849
852512Helianthus annuus pollen extract 0.05 GM/ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102450Helianthus annuus pollen extract 0.1 GM/ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849
852512Helianthus annuus pollen extract 1 GM per 20 ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102444Helianthus annuus pollen extract 1 MG/ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102450Helianthus annuus pollen extract 100 MG/ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102452Helianthus annuus pollen extract 1000 UNT/ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102454Helianthus annuus pollen extract 40,000 UNT/ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849
852512Helianthus annuus pollen extract 50 MG/ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102010Leucanthemum vulgare pollen extract 0.05 GM/ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102012Leucanthemum vulgare pollen extract 0.1 GM/ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102012Leucanthemum vulgare pollen extract 100 MG/ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102014Leucanthemum vulgare pollen extract 40,000 UNT/ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102010Leucanthemum vulgare pollen extract 50 MG/ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102045Taraxacum officinale pollen extract 0.001 GM/ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849
852082Taraxacum officinale pollen extract 0.05 GM/ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849
1014002Taraxacum officinale pollen extract 0.1 GM/ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102045Taraxacum officinale pollen extract 1 MG/ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849
1014002Taraxacum officinale pollen extract 100 MG/ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849
2102047Taraxacum officinale pollen extract 1000 UNT/ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849
1013972Taraxacum officinale pollen extract 20,000 UNT/ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849
1013974Taraxacum officinale pollen extract 40,000 UNT/ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849
852082Taraxacum officinale pollen extract 50 MG/ML Injectable SolutionSY7a04fcbd-969d-7acd-e053-2991aa0a7a849

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
22840-1501-1228401501015 mL in 1 VIAL, MULTI-DOSE (22840-1501-1) 5 ml1981-09-150000-00-00NoNoCurrent