Cough Drops 5.8 mg/1
Menthol · PASTILLE · United Natural Foods, Inc.
Cough Drops is a pastille containing menthol at 5.8 mg/1, taken oral. Manufactured by United Natural Foods, Inc..
Key Facts
- Brand Name
- Cough Drops
- Generic Name
- Menthol
- NDC Code (Product)
83455-201- Manufacturer
- United Natural Foods, Inc.
- Strength
- 5.8 mg/1
- Dosage Form
- PASTILLE
- Route
- ORAL
- Marketing Status
- Application #
- M012
- Marketing Start
- 05/12/2023
Recall History
A-S Medication Solutions LLC.
Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Bestco LLC
Subpotent drug: Low OOS for menthol content at the three month room temperature.
Bestco LLC
CGMP Deviations: Potential Glass and Silicone particulates in product
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Bestco LLC
CGMP Deviations: Potential Glass and Silicone particulates in product
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Bestco, Inc.
Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses temporarily relieves: cough as may occur with a cold occasional minor irritation and sore throat
Dosage & Administration
Directions adults and children 5 years and over - dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor. children under 5 years - ask a doctor
Warnings
Warnings Sore throat warning: if sor throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be serious.
Frequently Asked Questions
What is Cough Drops used for?
Cough Drops contains Menthol. It is a pastille taken oral. Consult your doctor for specific uses.
Is Cough Drops a controlled substance?
Cough Drops is not classified as a controlled substance by the DEA.
What is the generic name for Cough Drops?
The generic name for Cough Drops is Menthol. There are 12 other brand versions of Menthol.
What is the NDC code for Cough Drops 5.8 mg/1?
The NDC (National Drug Code) for Cough Drops 5.8 mg/1 is 83455-201, listed by United Natural Foods, Inc..
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)