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General product and regulatory information, not medical advice. For questions about a specific condom or a specific situation, ask a clinician or pharmacist.
Short answer
Condom shelf life is the period a manufacturer has shown, by testing, that a condom keeps its physical and mechanical integrity. For latex condoms regulated by the US FDA, the printed expiration date must be supported by test data and cannot be more than 5 years from the date of packaging. The date applies to condoms stored as the manufacturer directs; heat, light and chemicals can shorten it.
Definition and scope
A condom is defined in 21 CFR 884.5300 as a sheath that completely covers the penis with a closely fitting membrane. Natural rubber latex condoms and condoms made of other materials are both Class II devices under that regulation. Latex condoms, and spermicide-lubricated latex condoms covered by 21 CFR 884.5310, are subject to a dedicated expiration-dating rule, 21 CFR 801.435. That rule states the reason plainly: data show that the material integrity of latex condoms degrades over time, so each latex condom must carry an expiration date supported by testing.
This page covers how that date is set and where it must appear, and what published storage guidance says about keeping it valid. It does not cover how to use a condom. For the internal (female) condom, see internal condom, which has its own labeling and shelf-life notes.
How the expiration date is set (21 CFR 801.435)
The expiration date is not a manufacturer’s estimate. Under 801.435(d), it must be supported by data showing the physical and mechanical integrity of three discrete, representative lots after each of three storage conditions. In every condition the bulk product is first held unpackaged for the longest time the manufacturer allows, then the packaged product is stored as follows.
| Test | Storage condition | Duration |
|---|---|---|
| Accelerated | 70 °C (plus or minus 2 °C) | 7 days |
| Intermediate | A selected temperature between 40 and 50 °C (plus or minus 2 °C) | 90 days |
| Real time | Monitored or controlled temperature between 15 and 30 °C | The lifetime of the product |
Under 801.435(e), if the product passes the integrity tests after the accelerated and intermediate storage, the manufacturer may label an expiration date of up to 5 years from the date of product packaging. If that extrapolated date is used, it must be confirmed by integrity tests at the end of the stated period under real-time storage. If real-time data fail to confirm it, the manufacturer must relabel the product to reflect the actual shelf life. If a product fails after accelerated storage, the date must instead be demonstrated by real-time storage. Products with established real-time shelf-life data on file are treated separately under paragraph (f).
FDA’s 510(k) clearance letter K023333 (18 April 2003, checked 30 October 2026) repeats the same limits from the review side: labeling must comply with 801.435, the date must be supported by test data and displayed prominently and legibly, the manufacturer must keep the supporting data available for FDA inspection, and condoms are not to be labeled with an expiration date giving a shelf life of more than five years.
Where the date must appear
Section 801.435(c) requires the date on the primary packaging, meaning the individual package, and also on higher levels of packaging such as boxes, so that the date is visible to consumers. For a condom with a spermicidal lubricant, the clearance letter above says the spermicide’s shelf life is compared with the condom’s and the product is labeled with the earlier of the two expiration dates.
Storage conditions that shorten shelf life
Guidance for condom programs adapted from UNFPA, WHO and PATH material and published by the Minnesota Department of Health (checked 30 October 2026) gives these storage conditions for male latex condoms, whose typical shelf life it puts at three to five years:
- Keep below 40 °C (104 °F) and in low humidity.
- Keep away from direct sunlight, fluorescent light, electric motors and chemicals. The guidance also notes that ozone can destroy condoms within a few hours.
- Keep cartons at least 10 cm (4 in) off the floor and 30 cm (1 ft) from walls, with labels and expiration dates visible.
The same guidance says the polyurethane female condom has a manufacturer-determined five-year shelf life and is not sensitive to heat and humidity. Shelf lives for other materials vary by manufacturer; read the individual package. For background on one non-latex material, see what is polyisoprene.
Where it matters for clinics and supply programs
The Minnesota guidance describes a stock-control routine for programs that hold condoms in bulk. The checklist below is taken from it:
- On arrival, record the expiration date. If a carton shows only a manufacture date, add the product’s shelf life to it to get an expiry.
- Rotate stock first-expired, first-out, dispensing the oldest first. The principle is covered in FIFO vs FEFO expiration date rotation.
- Inspect regularly and at random. Do not dispense condoms that are damaged or defective, for example torn packaging, leaking lubricant, brittle or yellowed condoms, or broken seals.
- Take a physical inventory twice a year.
- Quarantine defective lots and report them to the supplier, recording the date, product, brand, type and lot number. See how to read a lot number.
Common misunderstandings
The 5-year figure is a ceiling, not a guarantee
801.435 allows a date of up to 5 years from packaging, and only when the testing supports it. A manufacturer whose data support less must print a shorter date, and must relabel if real-time data disagree.
The date counts from packaging, not from purchase
The regulation measures shelf life from the date of product packaging, so time spent in distribution and storage already counts against it.
The test conditions are not storage advice
The 70 °C and 40 to 50 °C conditions are laboratory aging tests used to support a date. They are not temperatures a condom should be exposed to; the real-time test is run at 15 to 30 °C.
FAQ
Do condoms expire?
Yes. Latex condoms sold in the United States must carry an expiration date supported by testing, because latex integrity degrades over time (21 CFR 801.435).
How long is a condom shelf life?
For latex condoms the printed date can be at most 5 years from packaging under 801.435. Program guidance cites a typical range of three to five years. Use the date printed on the package.
Where is the condom expiration date printed?
On the individual package and on boxes or other higher-level packaging. If the condom has a spermicidal lubricant, the date shown is the earlier of the condom’s and the spermicide’s.
What can shorten a condom’s shelf life?
Published storage guidance names temperatures above 40 °C, humidity, direct sunlight, fluorescent light, chemicals and ozone.
Sources
- 21 CFR 801.435, User labeling for latex condoms (eCFR, version dated 2026-10-01, checked 30 October 2026): https://www.ecfr.gov/current/title-21/section-801.435
- 21 CFR 884.5300, Condom (eCFR, checked 30 October 2026): https://www.ecfr.gov/current/title-21/section-884.5300
- FDA 510(k) clearance letter K023333, 18 April 2003 (checked 30 October 2026): https://www.accessdata.fda.gov/cdrh_docs/pdf2/k023333.pdf
- Minnesota Department of Health, Condom storage and distribution guidelines, adapted from UNFPA, WHO and PATH (checked 30 October 2026): https://www.health.mn.gov/diseases/hiv/partners/storage.pdf
