Xlear Cough Drops (Green Apple)

Manufacturer: Xlear Inc. | Primrose Candy Company
Effective date: 2023-01-10
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:53:02

Label at a glance#

ProductXlear Cough Drops (Green Apple)

Active ingredientMENTHOL

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

4.0mg of Menthol (per drop)

OTC - PURPOSE SECTION

Cough Suppressant / Oral Anesthetic

INDICATIONS & USAGE SECTION

Temporarily soothes an irritated or sore throat

INACTIVE INGREDIENT SECTION

Alfalfa, Isomalt, Malic Acid, Natural Apple Flavor, Stevia, Titanium Dioxide, Xytitol

DOSAGE & ADMINISTRATION SECTION

Adults and children over five - Slowly dissolve one drop every two hours as needed or as directed by a physician. Children under five - Consult your physician.

WARNINGS SECTION

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. If sore throat symptoms do not improve in 7 days, see your doctor promptly.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER SAFETY INFORMATION

Mfg. in a facility that processes dairy, peanut, almond, walnut, nutmeg, pecan, and soy protein.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
637117	menthol 4 MG Oral Lozenge	PSN	3
637117	menthol 4 MG Oral Lozenge	SCD	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
27017-021-01	2025-01-30	C162847	48780-1	2cef2736-5c04-d83d-e063-dadaa90ab31f	Xlear Cough Drops (Green Apple)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
27017-021-01	Xlear Cough Drops (Green Apple)	30 in 1 BOX	LOZENGE	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27017-021	XLEAR COUGH DROPS (GREEN APPLE) (MENTHOL) LOZENGE [XLEAR INC.]	3	Legacy NDC, 1 package rows	20230111_9986837f-2f2a-2806-e053-2995a90a5e6d.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Xlear Cough Drops (Green Apple)
Menthol
XYLITOL
MALIC ACID
STEVIA LEAF
ISOMALT
TITANIUM DIOXIDE
ALFALFA

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
27017-021	27017-021-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
XYLITOL	VCQ006KQ1E	IACT
MALIC ACID	817L1N4CKP	IACT
STEVIA LEAF	6TC6NN0876	IACT
ISOMALT	S870P55O2W	IACT
MENTHOL	L7T10EIP3A	ACTIB
TITANIUM DIOXIDE	15FIX9V2JP	IACT
ALFALFA	DJO934BRBD	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f1ec5d88-5cad-5f59-e053-2995a90ae2c8			9986837f-2f2a-2806-e053-2995a90a5e6d	2023-01-10	Warnings	Exact identifier spl id: f1ec5d88-5cad-5f59-e053-2995a90ae2c8 spl set id: 9986837f-2f2a-2806-e053-2995a90a5e6d

Reported adverse events (FAERS/openFDA)#

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