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A graduated medicine cup is a small container with calibrated measurement lines, used to measure a liquid medication before it is taken or given. FDA lists the device category as a “liquid medication dispenser” and classifies it as Class I. This page describes products and general use; it is not medical advice.
Who uses it: clinic and pharmacy staff, caregivers, buyers of clinic supplies, and students learning about dosage delivery devices.
What is a graduated medicine cup?
A graduated medicine cup is a measuring container whose side is marked with calibrated units of liquid measure, so a set amount of liquid medication can be poured to a marked line. In U.S. regulation the device is named a liquid medication dispenser: under 21 CFR 880.6430 it is “a device intended for medical purposes that is used to issue a measured amount of liquid medication” (eCFR, checked 2026-10-31).
FDA’s guidance on dosage delivery devices uses the broader phrase “dosage delivery device” and names cups, droppers, syringes and spoons as examples. The same expectations about markings apply to all of them. For syringes in general, see what a syringe is.
How is it regulated in the United States?
The liquid medication dispenser is a Class I device (general controls). Under 21 CFR 880.6430 it is exempt from premarket notification, subject to the limitations in 21 CFR 880.9, and exempt from the current good manufacturing practice requirements of the quality management system regulation (QMSR) in part 820, except for the requirements concerning records and complaint files under 21 CFR 820.35 (eCFR, checked 2026-10-31). The FDA product code for the category is KYW (openFDA device classification data, checked 2026-10-30).
| Item | What the regulation says |
|---|---|
| Device name | Liquid medication dispenser, 21 CFR 880.6430 |
| Class | Class I (general controls) |
| Premarket notification | Exempt, subject to the limitations in 21 CFR 880.9 |
| Quality management system regulation (part 820) | Exempt except the records and complaint-file requirements in 21 CFR 820.35 |
| Product code | KYW |
How should the markings read?
The marking rules that matter most come from FDA’s May 2011 nonbinding guidance, Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products (checked 2026-10-31). It is written for over-the-counter liquid drug products packaged with a device, and it is the clearest public statement of what “graduated” should mean in practice. Guidance is a set of recommendations, not a requirement.
| Marking point | What FDA recommends |
|---|---|
| Units | Calibrated units on the device (for example teaspoon, tablespoon or milliliter) should be the same as the units in the labeled directions on the carton, bottle and any written instructions. |
| Abbreviations | Use standard ones: “mL” for milliliters and “tsp” for teaspoons. Avoid nonstandard abbreviations, and define an abbreviation on the device (for example tsp = teaspoon) or in the labeling. |
| Trailing zeros | Do not use them: “4”, not “4.0”, to help avoid tenfold errors. |
| Leading zeros | Put a zero before a decimal point: “0.4”, not “.4”. |
| Fractions | Use smaller numerals for fractions so that, for example, “1/2” is not read as “1 or 2”. |
| Extra markings | The device should not bear extraneous or unnecessary liquid measure markings that may be confusing. |
What types does FDA name?
Cups, droppers, syringes and spoons
The guidance names dosage cups, droppers, syringes and spoons as dosage delivery devices. It treats them under the same marking recommendations and does not rank one above another. A “liquid medication dispenser” in the CFR is the umbrella device name, so a graduated cup, a dropper and an oral syringe can all fall under the same regulation title.
Labeling and packaging basics
- FDA treats written, printed or graphic matter on a dosage delivery device packaged with an over-the-counter liquid drug product as labeling, so the markings must be clear and consistent with the product’s directions for use.
- FDA recommends that manufacturers try to ensure a device is used only with the product it is packaged with, for example through a statement on the carton, bottle or device.
- The calibrated units on the device and the units in the labeled directions are meant to be the same, which is why the two are reviewed together.
Common mistakes
- Unit mismatch. FDA’s guidance describes reports of accidental overdose attributed in part to cup markings that were misleading or incompatible with the labeled directions. In its example, directions are written in teaspoons but the cup carries a different scale, or lacks the graduation the directions call for (such as 2 teaspoons or 1/2 teaspoon).
- Substituting household spoons. The guidance notes that confusing markings may lead people to less accurate means such as household spoons, with risk of underdosing or overdosing.
- Several scales on one cup. Extra scales that do not correspond to the directions are what FDA calls extraneous markings.
- Misread decimals. A missing leading zero or a trailing zero is the kind of notation FDA says can lead to tenfold errors.
FAQ
What is a liquid medication dispenser?
It is FDA’s regulatory name for a device used to issue a measured amount of liquid medication (21 CFR 880.6430). A graduated medicine cup is one common form of it.
Is a graduated medicine cup a medical device?
Yes. FDA classifies the liquid medication dispenser as a Class I medical device, exempt from premarket notification subject to 21 CFR 880.9.
What does “graduated” mean on a medicine cup?
It means the cup carries calibrated measurement lines. FDA recommends that the units on those lines match the units in the labeled directions, use standard abbreviations such as mL and tsp, and avoid unnecessary extra scales.
Are FDA’s marking recommendations mandatory?
The May 2011 document is labeled nonbinding: it sets out FDA’s recommendations. FDA also states that markings on a device packaged with an over-the-counter liquid drug product are labeling and must not be false or misleading.
Sources
All sources checked 2026-10-31 unless noted.
- 21 CFR 880.6430, Liquid medication dispenser, eCFR: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-880/subpart-G/section-880.6430
- FDA CDER, Guidance for Industry: Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products, May 2011, nonbinding: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dosage-delivery-devices-orally-ingested-otc-liquid-drug-products
- openFDA device classification, product code KYW (checked 2026-10-30): https://api.fda.gov/device/classification.json?search=product_code:KYW
Related reading: pediatric clinic supply checklist and ISMP targeted medication safety best practices.
