Quick answers
- What is Dactylis glomerata used for?
- The FDA-approved label (Standardized Redtop Grass, Allermed Laboratories, Inc., June 3, 2025) says: “Standardized grass pollen extract is indicated for use in the diagnosis of grass allergy in patients with a history of allergic symptoms that occur during grass pollination. Skin tests with standardized grass pollen extract should be done first by the puncture method using 10,000 BAU/mL extract. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dactylis glomerata have a boxed warning?
- Yes. The FDA label for Standardized Redtop Grass has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Dactylis glomerata?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dactylis glomerata been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Dactylis glomerata?
- 1 company lists prescription products of Dactylis glomerata in the FDA NDC Directory, including Allermed Laboratories, Inc..
What Dactylis glomerata is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Standardized grass pollen extract is indicated for use in the diagnosis of grass allergy in patients with a history of allergic symptoms that occur during grass pollination. Skin tests with standardized grass pollen extract should be done first by the puncture method using 10,000 BAU/mL extract. …
— FDA label: Standardized Redtop Grass, Allermed Laboratories, Inc., effective June 3, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Cutaneous · Intradermal · Subcutaneous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Standardized Orchard Grass |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Allermed Laboratories, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA102217 | — | Date not on file | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Standardized Redtop Grass, Allermed Laboratories, Inc., effective June 3, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →