Xlear Cough Drops (Black Cherry)

Manufacturer: Xlear Inc. | Primrose Candy Company
Effective date: 2023-01-10
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:53:02

Label at a glance#

ProductXlear Cough Drops (Black Cherry)

Active ingredientMENTHOL

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

4.0 mg of menthol (per drop)

OTC - PURPOSE SECTION

Cough Suppressant / Oral Anesthetic

INDICATIONS & USAGE SECTION

Temporarily soothes an irritated or sore throat

INACTIVE INGREDIENT SECTION

Bett Juice, Isomalt, Malic Acid, Natural Cherry Flavor, Stevia, Titanium Dioxide, Xylitol

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 2days, 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

Allergen Information: Mfg. in a facility that processes dairy, peanut, almond, walmut, 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	2
637117	menthol 4 MG Oral Lozenge	SCD	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
27017-020-01	2025-01-30	C162847	48780-1	2cef2736-96d4-d83d-e063-dadaa90ab31f	Xlear Cough Drops (Black Cherry)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
27017-020-01	Xlear Cough Drops (Black Cherry)	30 in 1 BOX	LOZENGE	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27017-020	XLEAR COUGH DROPS (BLACK CHERRY) (MENTHOL) LOZENGE [XLEAR INC.]	2	Legacy NDC, 1 package rows	20230111_9985caff-9b43-3e74-e053-2995a90a1da4.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 (Black Cherry)
Menthol
MALIC ACID
TITANIUM DIOXIDE
BEET JUICE
XYLITOL
STEVIA LEAF
ISOMALT

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
27017-020	27017-020-01

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
MALIC ACID	817L1N4CKP	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
BEET JUICE	IOZ32L9H3O	IACT
MENTHOL	L7T10EIP3A	ACTIB
XYLITOL	VCQ006KQ1E	IACT
STEVIA LEAF	6TC6NN0876	IACT
ISOMALT	S870P55O2W	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
f1ec6441-50ae-7764-e053-2995a90a851c			9985caff-9b43-3e74-e053-2995a90a1da4	2023-01-10	Warnings	Exact identifier spl id: f1ec6441-50ae-7764-e053-2995a90a851c spl set id: 9985caff-9b43-3e74-e053-2995a90a1da4

Reported adverse events (FAERS/openFDA)#

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