Food - Plant Source, Tomato Nicotiana spp.

Product NDC: 65044-3657
11-digit product format: 650443657
Labeler code: 65044
Product ID: 65044-3657_7aa227ef-6590-446b-af8f-bac308d1f226
Type: NON-STANDARDIZED ALLERGENIC
Nonproprietary name: Tomato Nicotiana spp.
Dosage form: INJECTION, SOLUTION
Route: PERCUTANEOUS
Labeler: Jubilant HollisterStier LLC
Application: BLA103888
Marketing category: BLA
Marketing start: 1941-04-19
Marketing end: 0000-00-00
Substance: TOMATO
Active strength: 0 g/mL
Pharmacologic classes: Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Vegetable Proteins [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65044-3657		D	Discontinued by firm	2026-08-03
excluded product	product	65044-3657		D	Discontinued by firm	2026-08-03
excluded package	package	65044-3657	65044-3657-1	D	Discontinued by firm	2026-08-03
excluded package	package	65044-3657	65044-3657-1	D	Discontinued by firm	2026-08-03

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 2 · 62 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65044-3657-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65044-3657-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65044-3657-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65044-3657-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65044-3657-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65044-3657-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65044-3657-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65044-3657-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65044-3657-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65044-3657-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65044-3657-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65044-3657-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65044-3657-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65044-3657-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65044-3657-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65044-3657-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65044-3657-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65044-3657-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65044-3657-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65044-3657-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65044-3657-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65044-3657-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65044-3657-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65044-3657-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	65044-3657-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	65044-3657-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	65044-3657-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	65044-3657-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	65044-3657-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	65044-3657-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65044-3657-1	2021-01-29	C162847	48780-1	ba0f9c33-4042-a910-e053-dadaa90a0b85	INSTRUCTIONS ALLERGENIC EXTRACTS FOR SCRATCH, PRICK OR PUNCTURE TESTING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65044-3657-1	Food - Plant Source, Tomato Nicotiana spp.	5 mL in 1 VIAL	INJECTION, SOLUTION	5		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65044-3657	FOOD - PLANT SOURCE, HAZELNUT FILBERT CORYLUS SPP. (HAZELNUT FILBERT CORYLUS SPP.) INJECTION, SOLUTION FOOD - PLANT SOURCE, MELON, CANTALOUPE CUCUMIS MELO (CANTALOUPE CUCUMIS MELO) INJECTION, SOLUTION FOOD - PLANT SOURCE, ORANGE CITRUS SINENSIS (ORANGE CITRUS SINENSIS) INJECTION, SOLUTION FOOD - PLANT SOURCE, PEA, GREEN OR ENGLISH PISUM SATIVUM (PEA, GREEN OR ENGLISH PISUM SATIVUM) INJECTION, SOLUTION FOOD - PLANT SOURCE, PEACH PRUNUS PERSICA (PEACH PRUNUS PERSICA) INJECTION, SOLUTION FOOD - PLANT SOURCE, PEANUT ARACHIS HYPOGAEA (PEANUT ARACHIS HYPOGAEA) INJECTION, SOLUTION FOOD - PLANT SOURCE, PECAN CARYA ILLINOENSIS (PECAN CARYA ILLINOENSIS) INJECTION, SOLUTION FOOD - PLANT SOURCE, POTATO, WHITE SOLANUM TUBEROSUM (POTATO, WHITE SOLANUM TUBEROSUM) INJECTION, SOLUTION FOOD - PLANT SOURCE, RICE, WHOLE GRAIN (RICE, WHOLE GRAIN) INJECTION, SOLUTION FOOD - PLANT SOURCE, RYE GRAIN (RYE GRAIN) INJECTION, SOLUTION FOOD - PLANT SOURCE, SOYBEAN GLYCINE SOJA (SOYBEAN GLYCINE SOJA) INJECTION, SOLUTION FOOD - PLANT SOURC	4	Legacy NDC, 1 package rows	20191122_768c463e-0c57-499e-8502-46dc9915808b.zip

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
Z4KHF2C175	TOMATO	TOMATO

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
900095	black walnut pollen extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
892520	cantaloupe allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
899958	hazelnut pollen extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
892568	orange allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
892572	pea allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
892578	peach allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
891663	peanut allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
892335	pecan allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
892635	potato allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
892664	rice (whole grain) allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
892641	rye allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
891675	soybean allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
892487	strawberry allergenic extract 50 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
891681	string bean allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
892502	tomato allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
900095	black walnut pollen extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
892520	cantaloupe allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
899958	hazelnut pollen extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
892568	orange allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
892572	pea allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
892578	peach allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
891663	peanut allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
892335	pecan allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
892635	potato allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
892664	rice (whole grain) allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
892641	rye allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
891675	soybean allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
892487	strawberry allergenic extract 50 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
891681	string bean allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
892502	tomato allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
892664	brown rice allergenic extract 100 MG/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892520	cantaloupe allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
899958	Corylus americana pollen extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
899958	Corylus americana pollen extract 100 MG/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
891681	green bean allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
900095	Juglans nigra pollen extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
900095	Juglans nigra pollen extract 100 MG/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892568	orange allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892572	pea allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
891663	peanut allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892335	pecan allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892578	Prunus (subgenus Amygdalus) persica allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892578	Prunus (subgenus Amygdalus) persica allergenic extract 100 MG/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892664	rice (whole grain) allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892641	rye allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892635	Solanum tuberosum allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892635	Solanum tuberosum allergenic extract 100 MG/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
891675	soybean allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892487	strawberry allergenic extract 0.05 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892502	tomato allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
65044-3657-1	65044365701	5 mL in 1 VIAL	5 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
INSTRUCTIONS ALLERGENIC EXTRACTS FOR SCRATCH, PRICK OR PUNCTURE TESTING	Jubilant HollisterStier LLC	2018-03-13	NON-STANDARDIZED ALLERGENIC LABEL	4