Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 0126-0016-61 recalled?

PreviDent 5000 Dry Mouth · 100 mL in 1 BOTTLE (0126-0016-61)

Yes — this exact package was recalled

1 FDA recall names the code 0126-0016-61 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

Active ingredient
Sodium fluoride
Strength
SODIUM FLUORIDE 6.1 mg/mL
Form
Gel, Dentifrice · Dental
Labeler
Colgate Oral Pharmaceuticals, Inc.
Type
Human Prescription Drug
Product code
0126-0016

Recalls naming this package

Class III · Low risk

PreviDent 5000 ppm

Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.

Terminated Labeling / mix-up Colgate Palmolive Co NDC 0126-0016-61 D-0521-2017

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.