Cough Drops 5.4 mg/1
Menthol · PASTILLE · Topco Associates LLC
Cough Drops is a pastille containing menthol at 5.4 mg/1, taken oral. Manufactured by Topco Associates LLC.
Key Facts
- Brand Name
- Cough Drops
- Generic Name
- Menthol
- NDC Code (Product)
76162-011- Manufacturer
- Topco Associates LLC
- Strength
- 5.4 mg/1
- Dosage Form
- PASTILLE
- Route
- ORAL
- Marketing Status
- Application #
- M012
- Marketing Start
- 12/14/2022
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
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 5.4 mg/1?
The NDC (National Drug Code) for Cough Drops 5.4 mg/1 is 76162-011, listed by Topco Associates LLC.
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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)