Menthol Cough Drop

Manufacturer
Safeway Inc. | BestCo Inc.
Effective date
2025-12-20
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:27:13

Label at a glance#

ProductMenthol Cough Drop
Active ingredientMENTHOL
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each drop)

Menthol 5.4 mg

OTC - PURPOSE SECTION

Purpose

Cough suppressant/Oral anesthetic

INDICATIONS & USAGE SECTION

Uses temporarily relieves:

cough as may occur with a cold

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, swelling, nausa, 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have:

  • persistent or chronic cough such as occurs with smoking, ashtma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

OTC - STOP USE SECTION

Stop use and consult doctor if

  • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • sore throat is severe, or irritation, pain, or redness lasts or worsens
  • sore mouth does not improve in 7 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

adults and children 5 years and over - allow 1 drop to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor

children under 5 years - ask a doctor

OTHER SAFETY INFORMATION

Other information

  • 10 calories per drop
  • do not use if bag is torn or open

INACTIVE INGREDIENT SECTION

Inactive ingredients: Corn starch, corn syrup, eucalyptus oil, FD&C blue no. 1, FD&C red no. 40, glycerin, gum arabic, medium chain triglycerides, natural flavor, potassium sorbate, soybean oil, sucrose and water.

OTC - QUESTIONS SECTION

Questions? Or to report an adverse event call 1-800-245-2898. Monday - Friday, 9AM to 4PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Signature Care Menthol 30ct Cough DropsSignature Care Menthol 30ct Cough Drops

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
485287menthol 5.4 MG Oral LozengePSN9
485287menthol 5.4 MG Oral LozengeSCD9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-265-30Menthol Cough Drop30 in 1 BAGLOZENGE309

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-26521130-265-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menthol Cough DropMENTHOLSafeway Inc.4a4f7f82-1b6c-7082-e054-00144ff88e882025-12-20WarningsExact identifier
ndc (package): 21130-265-30
ndc (product): 21130-265
ndc11 (package): 21130026530
spl id: 466821d9-2633-b2be-e063-6394a90a1e34
spl set id: 4a4f7f82-1b6c-7082-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.