FDA.reportPublic FDA data

Standardized Grass Pollen, Timothy

Product NDC
65044-0831
Requested package NDC
65044-0831-2
11-digit product format
650440831
Labeler code
65044
Product ID
65044-0831_3c14e8ca-64c9-463f-963d-5a2e31d01ad3
Type
STANDARDIZED ALLERGENIC
Nonproprietary name
Standardized Grass Pollen, Timothy
Dosage form
INJECTION, SOLUTION
Route
PERCUTANEOUS; SUBCUTANEOUS
Labeler
Jubilant HollisterStier LLC
Application
BLA103879
Marketing category
BLA
Marketing start
1998-01-15
Substance
PHLEUM PRATENSE POLLEN
Active strength
10000 [BAU]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage65044-083165044-0831-2DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 70 · 1,390 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hypertonic SalineSODIUM CHLORIDENAVEH PHARMA (1996) LTD167c7a9c-1228-4fb2-a89c-d3e1483863232026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsExact identifier
unii: 451W47IQ8X
DERMFREE INSECT BITE RELIEFSODIUM BICARBONATE 5% INSECT BITE RELIEFWenzhou Yuyuan Pharmaceutical Co., Ltd.5794886c-0d74-9f35-e063-6394a90a27d82026-07-27WarningsExact identifier
unii: 8MDF5V39QO
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCbbc5b820-4973-11e2-a192-0002a5d5c51b2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCc29bdfa0-4976-11e2-939b-0002a5d5c51b2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLC515dcee0-3e34-11e2-a25f-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: 8MDF5V39QO
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: PDC6A3C0OX
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsExact identifier
unii: 451W47IQ8X
Sodium BicarbonateSODIUM BICARBONATEAmneal Pharmaceuticals Private Limitedac91e834-e693-43a2-829b-56793453e8cc2026-07-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
unii: 451W47IQ8X
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: PDC6A3C0OX
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: PDC6A3C0OX

Additional Listing Data#

Finished product
Yes
Brand name base
Standardized Grass Pollen, Timothy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHLEUM PRATENSE POLLEN10000 [BAU]/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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65044-0831-1Standardized Grass Pollen, Timothy5 mL in 1 VIALINJECTION, SOLUTION514
65044-0831-2Standardized Grass Pollen, Timothy10 mL in 1 VIALINJECTION, SOLUTION1014
65044-0831-3Standardized Grass Pollen, Timothy30 mL in 1 VIALINJECTION, SOLUTION3014
65044-0831-4Standardized Grass Pollen, Timothy50 mL in 1 VIALINJECTION, SOLUTION5014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65044-0831STANDARDIZED GRASS POLLEN, FESCUE, MEADOW INJECTION, SOLUTION STANDARDIZED GRASS POLLEN, REDTOP INJECTION, SOLUTION STANDARDIZED GRASS POLLEN, ORCHARD GRASS INJECTION, SOLUTION STANDARDIZED GRASS POLLEN, BERMUDA GRASS INJECTION, SOLUTION STANDARDIZED GRASS POLLEN, TIMOTHY INJECTION, SOLUTION STANDARDIZED GRASS POLLEN, SWEET VERNAL GRASS INJECTION, SOLUTION STANDARDIZED GRASS POLLEN, RYEGRASS INJECTION, SOLUTION STANDARDIZED GRASS POLLEN, BLUEGRASS, KENTUCKY JUNE INJECTION, SOLUTION [JUBILANT HOLLISTERSTIER LLC]10Current NDC, Legacy NDC, 4 package rows20241105_3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103879Pollens - Grasses, Timothy Phleum pratense351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897496Bermuda grass pollen extract 10000 UNT/mL Injectable SuspensionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
852837Kentucky bluegrass pollen extract 10000 BAU/mL Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853278Kentucky bluegrass pollen extract 100000 BAU/mL Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851921meadow fescue grass pollen extract 10000 BAU/ML Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
854054meadow fescue grass pollen extract 100000 BAU/ML Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851881orchard grass pollen extract 10000 BAU/ML Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853047orchard grass pollen extract 100000 BAU/ML Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
852822perennial rye grass pollen extract 10000 BAU/ML Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853027perennial rye grass pollen extract 100000 BAU/ML Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853029redtop grass pollen extract 10000 BAU/ML Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851873redtop grass pollen extract 100000 BAU/ML Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851901sweet vernal grass pollen extract 10000 BAU/ML Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
854162sweet vernal grass pollen extract 100000 BAU/ML Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851997Timothy grass pollen extract 10000 BAU/mL Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
852157Timothy grass pollen extract 100000 BAU/mL Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
897496Bermuda grass pollen extract 10000 UNT/ML Injectable SuspensionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
852837Kentucky bluegrass pollen extract 10000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853278Kentucky bluegrass pollen extract 100000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851921meadow fescue grass pollen extract 10000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
854054meadow fescue grass pollen extract 100000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851881orchard grass pollen extract 10000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853047orchard grass pollen extract 100000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
852822perennial rye grass pollen extract 10000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853027perennial rye grass pollen extract 100000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853029redtop grass pollen extract 10000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851873redtop grass pollen extract 100000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851901sweet vernal grass pollen extract 10000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
854162sweet vernal grass pollen extract 100000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851997Timothy grass pollen extract 10000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
852157Timothy grass pollen extract 100000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853029Agrostis gigantea pollen extract 10,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851873Agrostis gigantea pollen extract 100,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851901Anthoxanthum odoratum grass pollen extract 10,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
854162Anthoxanthum odoratum grass pollen extract 100,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
897496Cynodon dactylon pollen extract 10,000 BAU/ML Injectable SuspensionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
897496Cynodon dactylon pollen extract 10,000 UNT/ML Injectable SuspensionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851881Dactylis glomerata pollen extract 10,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853047Dactylis glomerata pollen extract 100,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851921Festuca elatior grass pollen extract 10,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
854054Festuca elatior grass pollen extract 100,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851921Festuca pratensis grass pollen extract 10,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
854054Festuca pratensis grass pollen extract 100,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
852837June grass pollen extract 10,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853278June grass pollen extract 100,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
852822Lolium perenne grass pollen extract 10,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853027Lolium perenne grass pollen extract 100,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851921Lolium pratense grass pollen extract 10,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
854054Lolium pratense grass pollen extract 100,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
852157Phleum pratense grass pollen extract 100,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851997Phleum pratense pollen extract 10,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
852837Poa pratensis grass pollen extract 10,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853278Poa pratensis grass pollen extract 100,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851921Schedonorus pratensis grass pollen extract 10,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
854054Schedonorus pratensis grass pollen extract 100,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65044-0831-26504408310210 mL in 1 VIAL (65044-0831-2) 10 ml1998-01-150000-00-00NoNoCurrent