Standardized Sweet Vernal Grass
- Product NDC
- 49643-318
- 11-digit product format
- 496430318
- Labeler code
- 49643
- Product ID
- 49643-318_36ad5f03-e686-f1d0-e063-6394a90adfe8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Anthoxanthum odoratum
- Dosage form
- INJECTION
- Route
- CUTANEOUS; INTRADERMAL; SUBCUTANEOUS
- Labeler
- Allermed Laboratories, Inc.
- Application
- BLA102220
- Marketing category
- BLA
- Marketing start
- 1996-12-02
- Substance
- ANTHOXANTHUM ODORATUM POLLEN
- Active strength
- 100000 [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
- 2026-12-31
- Current FDA listing
- Yes
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 49643-318-30 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 49643-318-50 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 49643-318-10 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 49643-318-05 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 49643-318-30 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 49643-318-50 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 49643-318-10 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 49643-318-05 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 49643-318-30 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 49643-318-50 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 49643-318-10 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 49643-318-05 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 49643-318-30 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 49643-318-50 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 49643-318-10 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 49643-318-05 | 1332a3947898… | d4bfe170f9cd… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Standardized Sweet Vernal Grass
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ANTHOXANTHUM ODORATUM POLLEN | 100000 [BAU]/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4T81LB52R0 | Internal UNII lookup |
| 83N78IDA7P | Internal UNII lookup |
| 65M88RW2EG | Internal UNII lookup |
| SCB8J7LS3T | Internal UNII lookup |
| HU8V6E7HOA | Internal UNII lookup |
| 2KIK19R45Y | Internal UNII lookup |
| A0WFQ8P6N1 | Internal UNII lookup |
| 175F461W10 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d33c3aed-f487-45ed-a465-365170c6450a | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49643-318-05 | Standardized Sweet Vernal Grass | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION | 5 | 5 | |
| 49643-318-10 | Standardized Sweet Vernal Grass | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION | 10 | 5 | |
| 49643-318-30 | Standardized Sweet Vernal Grass | 30 mL in 1 VIAL, MULTI-DOSE | INJECTION | 30 | 5 | |
| 49643-318-50 | Standardized Sweet Vernal Grass | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION | 50 | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49643-318 | STANDARDIZED MEADOW FESCUE GRASS (FESTUCA ELATIOR) INJECTION STANDARDIZED ORCHARD GRASS (DACTYLIS GLOMERATA) INJECTION STANDARDIZED PERENNIAL RYE GRASS (LOLIUM PERENNE) INJECTION STANDARDIZED KENTUCKY BLUE (JUNE) GRASS (POA PRATENSIS) INJECTION STANDARDIZED BERMUDA GRASS (CYNODON DACTYLON) INJECTION STANDARDIZED REDTOP GRASS (AGROSTIS ALBA) INJECTION STANDARDIZED SWEET VERNAL GRASS (ANTHOXANTHUM ODORATUM) INJECTION STANDARDIZED TIMOTHY GRASS (PHLEUM PRATENSE) INJECTION [ALLERMED LABORATORIES, INC.] | 4 | Current NDC, Legacy NDC, 4 package rows | 20250121_d33c3aed-f487-45ed-a465-365170c6450a.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Standardized Redtop Grass | AGROSTIS ALBA | Allermed Laboratories, Inc. | d33c3aed-f487-45ed-a465-365170c6450a | 2025-06-03 | Boxed warning, Warnings, Adverse reactions | BLA102220 49643-318 |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 102220 | Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum | 351(a) | Rx | 2026-06-01 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 897496 | Bermuda grass pollen extract 10000 UNT/mL Injectable Suspension | PSN | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 853278 | Kentucky bluegrass pollen extract 100000 BAU/mL Injectable Solution | PSN | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 854054 | meadow fescue grass pollen extract 100000 BAU/ML Injectable Solution | PSN | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 853047 | orchard grass pollen extract 100000 BAU/ML Injectable Solution | PSN | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 853027 | perennial rye grass pollen extract 100000 BAU/ML Injectable Solution | PSN | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 851873 | redtop grass pollen extract 100000 BAU/ML Injectable Solution | PSN | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 854162 | sweet vernal grass pollen extract 100000 BAU/ML Injectable Solution | PSN | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 852157 | Timothy grass pollen extract 100000 BAU/mL Injectable Solution | PSN | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 897496 | Bermuda grass pollen extract 10000 UNT/ML Injectable Suspension | SCD | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 853278 | Kentucky bluegrass pollen extract 100000 BAU/ML Injectable Solution | SCD | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 854054 | meadow fescue grass pollen extract 100000 BAU/ML Injectable Solution | SCD | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 853047 | orchard grass pollen extract 100000 BAU/ML Injectable Solution | SCD | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 853027 | perennial rye grass pollen extract 100000 BAU/ML Injectable Solution | SCD | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 851873 | redtop grass pollen extract 100000 BAU/ML Injectable Solution | SCD | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 854162 | sweet vernal grass pollen extract 100000 BAU/ML Injectable Solution | SCD | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 852157 | Timothy grass pollen extract 100000 BAU/ML Injectable Solution | SCD | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 851873 | Agrostis gigantea pollen extract 100,000 BAU/ML Injectable Solution | SY | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 854162 | Anthoxanthum odoratum grass pollen extract 100,000 BAU/ML Injectable Solution | SY | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 897496 | Cynodon dactylon pollen extract 10,000 BAU/ML Injectable Suspension | SY | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 897496 | Cynodon dactylon pollen extract 10,000 UNT/ML Injectable Suspension | SY | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 853047 | Dactylis glomerata pollen extract 100,000 BAU/ML Injectable Solution | SY | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 854054 | Festuca elatior grass pollen extract 100,000 BAU/ML Injectable Solution | SY | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 854054 | Festuca pratensis grass pollen extract 100,000 BAU/ML Injectable Solution | SY | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 853278 | June grass pollen extract 100,000 BAU/ML Injectable Solution | SY | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 853027 | Lolium perenne grass pollen extract 100,000 BAU/ML Injectable Solution | SY | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 854054 | Lolium pratense grass pollen extract 100,000 BAU/ML Injectable Solution | SY | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 852157 | Phleum pratense grass pollen extract 100,000 BAU/ML Injectable Solution | SY | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 853278 | Poa pratensis grass pollen extract 100,000 BAU/ML Injectable Solution | SY | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
| 854054 | Schedonorus pratensis grass pollen extract 100,000 BAU/ML Injectable Solution | SY | d33c3aed-f487-45ed-a465-365170c6450a | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49643-318-05 | 49643031805 | 5 mL in 1 VIAL, MULTI-DOSE (49643-318-05) | 5 ml | 1996-12-02 | 0000-00-00 | No | No | Current |
| 49643-318-10 | 49643031810 | 10 mL in 1 VIAL, MULTI-DOSE (49643-318-10) | 10 ml | 1996-12-02 | 0000-00-00 | No | No | Current |
| 49643-318-30 | 49643031830 | 30 mL in 1 VIAL, MULTI-DOSE (49643-318-30) | 30 ml | 1996-12-02 | 0000-00-00 | No | No | Current |
| 49643-318-50 | 49643031850 | 50 mL in 1 VIAL, MULTI-DOSE (49643-318-50) | 50 ml | 1996-12-02 | 0000-00-00 | No | No | Current |