21 CFR 349.18
Ophthalmic vasoconstrictors
21 CFR 349.18 is the regulation titled “Ophthalmic vasoconstrictors” in 21 CFR Part 349, Ophthalmic Drug Products for Over-the-Counter Human Use. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 200.50, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a drug letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 12021
- 02022
- 02023
- 02024
- 02025
- 02026
The regulation
Read the text of 21 CFR 349.18 (eCFR, as of Sep 1, 2026)
The active ingredient of the product consists of one of the following, within the established concentration for each ingredient:
(a) Ephedrine hydrochloride, 0.123 percent.
(b) Naphazoline hydrochloride, 0.01 to 0.03 percent.
(c) Phenylephrine hydrochloride, 0.08 to 0.2 percent.
(d) Tetrahydrozoline hydrochloride, 0.01 to 0.05 percent.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 349.18.
- 21 CFR 200.50Ophthalmic preparations and dispensers1 letter cites both
- 21 CFR 201.128Meaning of “intended uses”1 letter cites both
- 21 CFR 211.113Control of microbiological contamination1 letter cites both
- 21 CFR 211.166Stability testing1 letter cites both
- 21 CFR 211.192Production record review1 letter cites both
- 21 CFR 211.67Equipment cleaning and maintenance1 letter cites both
Latest letters citing it
The letter citing 21 CFR 349.18 that FDA posted most recently.
See the letter citing 21 CFR 349.18 →Put this kind of reading to
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Counts include every citation in a letter, as the Letters filter does. How this database is built.