MAPLE/BOX ELDER

Product NDC: 0268-8031
11-digit product format: 002688031
Labeler code: 0268
Product ID: 0268-8031_0521d788-9ddb-4e34-a990-62ccf60a4402
Type: NON-STANDARDIZED ALLERGENIC
Nonproprietary name: ACER NEGUNDO POLLEN and ACER SACCHARUM POLLEN
Dosage form: INJECTION, SOLUTION
Route: PERCUTANEOUS
Labeler: ALK-Abello, Inc.
Application: BLA103753
Marketing category: BLA
Marketing start: 1965-01-01
Substance: ACER NEGUNDO POLLEN; ACER SACCHARUM POLLEN
Active strength: .05; .05 g/mL; g/mL
Pharmacologic classes: Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], 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: MAPLE/BOX ELDER
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACER NEGUNDO POLLEN	.05 g/mL
ACER SACCHARUM POLLEN	.05 g/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0268-8031-06	MAPLE/BOX ELDER	5.5 mL in 1 VIAL	INJECTION, SOLUTION	5.5		11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0268-8031	4 WEED MIX (AMARANTHUS RETROFLEXUS POLLEN, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN AND XANTHIUM STRUMARIUM POLLEN) INJECTION, SOLUTION 9 TREE MIX (ACER SACCHARUM POLLEN, ALNUS RHOMBIFOLIA POLLEN, BETULA LENTA POLLEN, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS ALBA POLLEN, QUERCUS ALBA POLLEN AND ULMUS CRASSIFOLIA POLLEN) INJECTION, SOLUTION BIRCH MIX (BETULA NIGRA POLLEN AND BETULA POPULIFOLIA POLLEN) INJECTION, SOLUTION HICKORY/ PECAN MIX (CARYA ILLINOINENSIS POLLEN AND CARYA OVATA POLLEN) INJECTION, SOLUTION MAPLE/BOX ELDER (ACER NEGUNDO POLLEN AND ACER SACCHARUM POLLEN) INJECTION, SOLUTION MAPLE MIX (ACER NEGUNDO POLLEN AND ACER RUBRUM POLLEN) INJECTION, SOLUTION MIXED COCKROACH (BLATELLA GERMANICA AND PERIPLANETA AMERICANA) INJECTION, SOLUTION MIXED FEATHERS (ANAS PLATYRHYNCHOS FEATHER, ANSER ANSER FEATHER AND GALLUS GALLUS FEATHER) INJECTION, SOLUTION MIXED WEEDS (CHENOPODIUM ALBUM POLLEN, IVA ANNUA POLLEN, PLANTAGO LANCEOLATA POLLEN AND XANTHIUM STR	11	Current NDC, Legacy NDC, 1 package rows	20230308_c7c0bc70-b640-4d1d-ac14-ade0fd8b8575.zip

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
P6K070AR8V	ACER NEGUNDO POLLEN	ACER NEGUNDO POLLEN
V38QUQ7861	ACER SACCHARUM POLLEN	ACER SACCHARUM POLLEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1735534	American cockroach allergenic extract 50 MG/mL / German cockroach allergenic extract 50 MG/mL Injectable Solution	PSN	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852165	black willow pollen extract 50 MG/ML Injectable Solution	PSN	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
2171890	box elder maple pollen extract 50 MG/mL / hard maple pollen extract 50 MG/mL Injectable Solution	PSN	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927623	box elder maple pollen extract 50 MG/ML / red maple pollen extract 50 MG/ML Injectable Solution	PSN	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852082	dandelion pollen extract 50 MG/ML Injectable Solution	PSN	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927658	gray birch pollen extract 50 MG/ML / river birch pollen extract 50 MG/ML Injectable Solution	PSN	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852049	nettle pollen extract 50 MG/ML Injectable Solution	PSN	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927683	pecan pollen extract 50 MG/ML / shagbark hickory pollen extract 50 MG/ML Injectable Solution	PSN	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
896138	short ragweed pollen extract 50 MG/ML Injectable Solution	PSN	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1735534	American cockroach allergenic extract 50 MG/ML / German cockroach allergenic extract 50 MG/ML Injectable Solution	SCD	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852165	black willow pollen extract 50 MG/ML Injectable Solution	SCD	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
2171890	box elder maple pollen extract 50 MG/ML / hard maple pollen extract 50 MG/ML Injectable Solution	SCD	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927623	box elder maple pollen extract 50 MG/ML / red maple pollen extract 50 MG/ML Injectable Solution	SCD	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852082	dandelion pollen extract 50 MG/ML Injectable Solution	SCD	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927658	gray birch pollen extract 50 MG/ML / river birch pollen extract 50 MG/ML Injectable Solution	SCD	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852049	nettle pollen extract 50 MG/ML Injectable Solution	SCD	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927683	pecan pollen extract 50 MG/ML / shagbark hickory pollen extract 50 MG/ML Injectable Solution	SCD	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
896138	short ragweed pollen extract 50 MG/ML Injectable Solution	SCD	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927623	Acer negundo pollen extract 0.05 GM/ML / Acer rubrum pollen extract 0.05 GM/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
2171890	Acer negundo pollen extract 0.05 GM/ML / Acer saccharum pollen extract 0.05 GM/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927623	Acer negundo pollen extract 50 MG/ML / Acer rubrum pollen extract 50 MG/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
2171890	Acer negundo pollen extract 50 MG/ML / Acer saccharum pollen extract 50 MG/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
896138	Ambrosia artemisiifolia pollen extract 0.05 GM/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
896138	Ambrosia artemisiifolia pollen extract 50 MG/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927658	Betula nigra pollen extract 0.05 GM/ML / Betula populifolia pollen extract 0.05 GM/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927658	Betula nigra pollen extract 50 MG/ML / Betula populifolia pollen extract 50 MG/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852165	black willow pollen extract 0.05 GM/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927683	Carya illinoinensis pollen 0.05 GM/ML / Carya ovata pollen extract 0.05 GM/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1927683	Carya illinoinensis pollen 50 MG/ML / Carya ovata pollen extract 50 MG/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
1735534	Periplaneta americana allergenic extract 0.05 GM/ML / Blatella germanica allergenic extract 0.05 GM/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852165	Salix nigra pollen extract 0.05 GM/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852165	Salix nigra pollen extract 50 MG/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852082	Taraxacum officinale pollen extract 0.05 GM/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852082	Taraxacum officinale pollen extract 50 MG/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852049	Urtica dioica pollen extract 0.05 GM/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11
852049	Urtica dioica pollen extract 50 MG/ML Injectable Solution	SY	c7c0bc70-b640-4d1d-ac14-ade0fd8b8575	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0268-8031-06	00268803106	5.5 mL in 1 VIAL (0268-8031-06)	5.5 ml	1965-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Scratch NonStandardized Products	ALK-Abello, Inc.	2023-03-10	NON-STANDARDIZED ALLERGENIC LABEL	11

MAPLE/BOX ELDER

Additional Listing Data#

Active Ingredients#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#