Menthol
- Manufacturer
- McKesson | Pharmaloz Manufacturing, Inc. | Prestige Packaging
- Effective date
- 2024-10-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-06-01 00:24:16
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each drop)
Menthol 7.6 mg
OTC - PURPOSE SECTION
Purpose
Antitussive (cough suppressant)/oral anesthetic
INDICATIONS & USAGE SECTION
Uses
Temporarily relieves
- cough as may occur with a cold or inhaled irritants
- occasional minor irritation and sore throat
WARNINGS SECTION
Warnings
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. These symptoms may be serious.
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough accompanied by excessive phlegm (mucus)
OTC - STOP USE SECTION
Stop use and ask a doctor if
- cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
- sore mouth does not improve in 7 days
- irritation, pain, or redness persists or worsens
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep this and all drugs out of the reach of children.
DOSAGE & ADMINISTRATION SECTION
Directions
- do not use more than directed
Adults and children: (12 years and older)
- Allow 1 drop to dissolve slowly in the mouth.
- May be repeated every 2 hours as necessary or as directed by a doctor.
Children under 12 years:
Do not give to children under 12 years of age.
OTHER SAFETY INFORMATION
Other information
- 15 calories per drop
- store at 59º-86ºF (15º-30ºC)
- protect from moisture & heat
INACTIVE INGREDIENT SECTION
Inactive ingredients:
cherry flavor, corn syrup, eucalyptus oil, FD&C red #40, sucrose
OTC - QUESTIONS SECTION
Questions?1-800-777-4908
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 68599-0464-9
McKesson
Cough Drops
Menthol Eucalyptus
250 per Jar
MFR# 27996M
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68599-0464-9 | 2022-10-24 | C162847 | 48780-1 | d6a99b39-4d89-a426-e053-dadaa90af4c2 | Menthol Eucalyptus |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68599-0464-9 | Menthol | 0.7 g in 1 JAR | LOZENGE | 0.7 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68599-0464 | MENTHOL (COUGH SUPPRESSANT) LOZENGE [MCKESSON] | 8 | Current NDC, Legacy NDC, 1 package rows | 20241012_9d4def70-480f-f2fa-e053-2995a90a9877.zip |
Products#
Every source-derived product name is available through these pages.
- Menthol
- Cough Suppressant
- EUCALYPTUS OIL
- SUCROSE
- CORN SYRUP
- MENTHOL, UNSPECIFIED FORM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68599-0464 | 68599-0464-9 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| EUCALYPTUS OIL | 2R04ONI662 | IACT |
| SUCROSE | C151H8M554 | IACT |
| CORN SYRUP | 9G5L16BK6N | IACT |
| MENTHOL, UNSPECIFIED FORM | L7T10EIP3A | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Menthol | COUGH SUPPRESSANT | McKesson | 9d4def70-480f-f2fa-e053-2995a90a9877 | 2024-10-10 | Warnings | 68599-0464-9 68599-0464 68599046409 24241327-4250-104a-e063-6294a90a41e7 9d4def70-480f-f2fa-e053-2995a90a9877 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
