FDA.reportPublic FDA data

Flaxseed

Product NDC
49288-0201
11-digit product format
492880201
Labeler code
49288
Product ID
49288-0201_afc65820-1d95-4bc6-81a6-ef5ca82cbd81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flaxseed
Dosage form
INJECTION, SOLUTION
Route
INTRADERMAL; SUBCUTANEOUS
Labeler
Antigen Laboratories, Inc.
Application
BLA102223
Marketing category
BLA
Marketing start
1974-03-23
Marketing end
0000-00-00
Substance
FLAX SEED
Active strength
0 g/mL
Pharmacologic classes
Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49288-0201IInactivated by FDA2026-08-10
excluded packagepackage49288-020149288-0201-1IInactivated by FDA2026-08-10
excluded packagepackage49288-020149288-0201-2IInactivated by FDA2026-08-10
excluded packagepackage49288-020149288-0201-3IInactivated by FDA2026-08-10
excluded packagepackage49288-020149288-0201-4IInactivated by FDA2026-08-10
excluded packagepackage49288-020149288-0201-5IInactivated by FDA2026-08-10

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 3 · 132 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49288-0201-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49288-0201-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49288-0201-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49288-0201-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49288-0201-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49288-0201-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49288-0201-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49288-0201-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49288-0201-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49288-0201-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49288-0201-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49288-0201-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49288-0201-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49288-0201-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49288-0201-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49288-0201-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49288-0201-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49288-0201-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49288-0201-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49288-0201-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49288-0201-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49288-0201-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49288-0201-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49288-0201-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49288-0201-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49288-0201-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49288-0201-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49288-0201-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49288-0201-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49288-0201-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49288-0201-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49288-0201-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49288-0201-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49288-0201-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49288-0201-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49288-0201-5ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49288-0201-4ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49288-0201-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49288-0201-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49288-0201-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49288-0201-50efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49288-0201-40efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49288-0201-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49288-0201-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49288-0201-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49288-0201-5ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49288-0201-4ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49288-0201-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49288-0201-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49288-0201-3ad56d346431e…cc804d4bbf1e…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
49288-0201-1Allergenic Extract “For Diagnostic Use Only”
49288-0201-2Allergenic Extract “For Diagnostic Use Only”
49288-0201-3Allergenic Extract “For Diagnostic Use Only”
49288-0201-4Allergenic Extract “For Diagnostic Use Only”
49288-0201-5Allergenic Extract “For Diagnostic Use Only”

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49288-0201-1Flaxseed2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION22
49288-0201-2Flaxseed5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION52
49288-0201-3Flaxseed10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION102
49288-0201-4Flaxseed30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION302
49288-0201-5Flaxseed50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION502

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARABICA COFFEE BEANACTIVE INGREDIENT3SW678MX72FLAXSEED INJECTION, SOLUTION COFFEE INJECTION, SOLUTION COTTONSEED INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
COTTON SEEDACTIVE INGREDIENTDI0ZRJ0MXNFLAXSEED INJECTION, SOLUTION COFFEE INJECTION, SOLUTION COTTONSEED INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
FLAX SEEDACTIVE INGREDIENT4110YT348CFLAXSEED INJECTION, SOLUTION COFFEE INJECTION, SOLUTION COTTONSEED INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
ARABICA COFFEE BEANACTIVE MOIETY3SW678MX72FLAXSEED INJECTION, SOLUTION COFFEE INJECTION, SOLUTION COTTONSEED INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
COTTON SEEDACTIVE MOIETYDI0ZRJ0MXNFLAXSEED INJECTION, SOLUTION COFFEE INJECTION, SOLUTION COTTONSEED INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
FLAX SEEDACTIVE MOIETY4110YT348CFLAXSEED INJECTION, SOLUTION COFFEE INJECTION, SOLUTION COTTONSEED INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFLAXSEED INJECTION, SOLUTION COFFEE INJECTION, SOLUTION COTTONSEED INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOFLAXSEED INJECTION, SOLUTION COFFEE INJECTION, SOLUTION COTTONSEED INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFLAXSEED INJECTION, SOLUTION COFFEE INJECTION, SOLUTION COTTONSEED INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RFLAXSEED INJECTION, SOLUTION COFFEE INJECTION, SOLUTION COTTONSEED INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49288-0201FLAXSEED INJECTION, SOLUTION COFFEE INJECTION, SOLUTION COTTONSEED INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2Legacy NDC, 5 package rows20091120_040dacaf-4ccf-425a-9b40-586176b7631d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891505arabica coffee bean allergenic extract 50 MG/ML Injectable SolutionPSN040dacaf-4ccf-425a-9b40-586176b7631d2
966958cottonseed allergenic extract 50 MG/mL Injectable SolutionPSN040dacaf-4ccf-425a-9b40-586176b7631d2
978958flaxseed allergenic extract 50 MG/ML Injectable SolutionPSN040dacaf-4ccf-425a-9b40-586176b7631d2
891505arabica coffee bean allergenic extract 50 MG/ML Injectable SolutionSCD040dacaf-4ccf-425a-9b40-586176b7631d2
966958cottonseed allergenic extract 50 MG/ML Injectable SolutionSCD040dacaf-4ccf-425a-9b40-586176b7631d2
978958flaxseed allergenic extract 50 MG/ML Injectable SolutionSCD040dacaf-4ccf-425a-9b40-586176b7631d2
891505arabica coffee bean allergenic extract 0.05 GM/ML Injectable SolutionSY040dacaf-4ccf-425a-9b40-586176b7631d2
891505arabica coffee bean extract 50 MG/ML Injectable SolutionSY040dacaf-4ccf-425a-9b40-586176b7631d2
966958cottonseed allergenic extract 0.05 GM/ML Injectable SolutionSY040dacaf-4ccf-425a-9b40-586176b7631d2
978958flaxseed allergenic extract 0.05 GM/ML Injectable SolutionSY040dacaf-4ccf-425a-9b40-586176b7631d2
978958flaxseed extract 50 MG/ML Injectable SolutionSY040dacaf-4ccf-425a-9b40-586176b7631d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
49288-0201-1492880201012 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
49288-0201-2492880201025 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
49288-0201-34928802010310 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
49288-0201-44928802010430 mL in 1 VIAL, MULTI-DOSE30 mlHistorical
49288-0201-54928802010550 mL in 1 VIAL, MULTI-DOSE50 mlHistorical