FDA.reportPublic FDA data

Lemon Glycerine

Manufacturer
PHOENIX HEALTHCARE SOLUTIONS, LLC
Effective date
2025-10-23
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:40:07

Label at a glance#

ProductLemon Glycerine Swabsticks
Active ingredientGLYCERIN
Label structure8 sections

Indications and uses

For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat. Dry mouth relief.

Dosage and administration

Swab mouth as needed Discard after single use. Children under the age of 12 should be supervised in the use of this product. Children under 2 years of age consult a doctor.

Storage and handling

Store at room temperature: 15 C - 30 C Avoid excessive heat

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Glycerin 7.5% v/v

Purpose

OTC - PURPOSE SECTION

Oral Demulcent

Uses

INDICATIONS & USAGE SECTION

  • For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.
  • Dry mouth relief.

Warnings

WARNINGS SECTION

For Oral Use Only.

Do not use

OTC - DO NOT USE SECTION

Do not get in eyes

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Swab mouth as needed
  • Discard after single use.
  • Children under the age of 12 should be supervised in the use of this product.
  • Children under 2 years of age consult a doctor.

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature: 15 C - 30 C
  • Avoid excessive heat

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Citric acid, lemon flavor, sodium benzoate, water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 60913-061-01

Phoenix Healthcare Solutions LLC

"An Innovative Medical Manufacturer"

Lemon-Glycerine Swabsticks

For Professional and Hospital Use

Antiseptic/Germicide

50 Pouches Per Box

1 Swabstick Per Pouch

LabelLabel

NDC 60913-061-03

Phoenix Healthcare Solutions LLC

"An Innovative Medical Manufacturer"

Lemon-Glycerine Swabsticks

For Professional and Hospital Use

Antiseptic/Germicide

25 Pouches Per Box

3 Swabstick Per Pouch

Label 1Label 1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1114098glycerin 7.5 % Medicated PadPSN10
1114098glycerin 75 MG/ML Medicated PadSCD10
1114098glycerin 7.5 % Medicated SwabSY10

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60913-061-01Lemon GlycerineSwabsticks50 in 1 BOXSWAB5010
60913-061-01Lemon GlycerineSwabsticks1 in 1 POUCHSWAB110
60913-061-03Lemon GlycerineSwabsticks3 in 1 POUCHSWAB310
60913-061-03Lemon GlycerineSwabsticks25 in 1 BOXSWAB2510

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OX1
GLYCERINACTIVE MOIETYPDC6A3C0OX1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60913-06160913-061-01, 60913-061-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92024-10-17full-release2026-06-01 00:27:02

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii+route
15 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSWAB / TOPICAL0.05 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii+route
15 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSWAB / TOPICAL0.05 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii+route
15 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSWAB / TOPICAL0.05 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii+route
15 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii+route
15 equally ranked IID candidates

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
Lemon Glycerine SwabsticksGLYCERINEPHOENIX HEALTHCARE SOLUTIONS, LLC436919f7-14cd-4318-9388-b3e1cbec176b2025-10-23WarningsExact identifier
ndc (package): 60913-061-01
ndc (package): 60913-061-03
ndc (product): 60913-061
ndc11 (package): 60913006101
ndc11 (package): 60913006103
spl id: 41d32695-4fde-35dd-e063-6294a90a7a40
spl set id: 436919f7-14cd-4318-9388-b3e1cbec176b

Reported adverse events (FAERS/openFDA)#

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