FDA.reportPublic FDA data

DG Health Oral Pain Reliever Gel 0.33oz (568, 2018)

Manufacturer
Dolgencorp LLC
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:39:54

Label at a glance#

ProductDollar General Health Oral Pain Reliever
Active ingredientBENZOCAINE HYDROCHLORIDE
Label structure10 sections

Storage and handling

Other information store at 15° to 25°C (59° to 77°) do not use if tube tip is cut prior to opening this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted do not use continusly Lot No. & Exp. Date: see box or see crimp of tube

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                                                           Purpose

Benzocaine 20%......................................................... Oral Pain Reliever

OTC - PURPOSE SECTION

Uses

for the temporary relief of pain due to toothaches

WARNINGS SECTION

Warnings

Allergy Alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

OTC - DO NOT USE SECTION

Do not use

  • more than directed
  • for more than 7 days unless told to do so by a dentist or doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • symptoms do not get better in 7 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children:

in case of overdose or allergic reaction, get medical help or contact a Poison Control Center immediately

INDICATIONS & USAGE SECTION

Directions

  • remove cap and cut tip on score mark
  • adults and children 2 years of age and older: apply a small amount of product to cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a doctor or dentist.
  • children under 12 years of age: should be supervised in the use of this product
  • children under 2 years of age: ask a doctor or dentist

STORAGE AND HANDLING SECTION

Other information

  • store at 15° to 25°C (59° to 77°)
  • do not use if tube tip is cut prior to opening
  • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
  • do not use continusly
  • Lot No. & Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT SECTION

Inactive ignredients

glycerin, mint flavor, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

568568

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOCAINE HYDROCHLORIDEACTIVE INGREDIENTOG625Z9LEO1
BENZOCAINEACTIVE MOIETYU3RSY48JW51
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D951
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
SORBITOLINACTIVE INGREDIENT506T60A25R1

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-56855910-568-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYETHYLENE GLYCOL 40004R4HFI6D95IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
BENZOCAINE HYDROCHLORIDEOG625Z9LEOACTIB

Source Document#

Source XML

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 4 · 211 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / OPHTHALMIC46 mgExact identifier — unii candidate
36 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYAEROSOL, METERED / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION, SOLUTION / SUBCUTANEOUS4.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYCAPSULE / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
36 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii candidate
44 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95TABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYCONCENTRATE / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
36 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / OPHTHALMIC6 mgExact identifier — unii candidate
44 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95SOLUTION / ORAL2667 mgExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAMUSCULAR22 mgExact identifier — unii candidate
34 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / BUCCAL5110 mgExact identifier — unii candidate
44 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCREAM / TOPICAL10 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / ORAL43 mgExact identifier — unii candidate
34 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSYRUP / ORAL740 mgExact identifier — unii candidate
36 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / DENTAL0.05 %w/vExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYWAFER / ORAL8 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE, DENTIFRICE / DENTAL0.2 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95CAPSULE, DELAYED RELEASE / ORAL1.28 mgExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95SUPPOSITORY / VAGINALNAExact identifier — unii candidate
22 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SOLUTION / ORAL199 mgExact identifier — unii candidate
34 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
36 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQOINTMENT / TOPICAL1950 mgExact identifier — unii candidate
36 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
34 equally ranked IID candidates
SORBITOLSORBITOL506T60A25ROINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSWAB / TOPICAL5250 mgExact identifier — unii candidate
36 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSPONGE / TOPICALNAExact identifier — unii candidate
36 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RELIXIR / ORAL833.3 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RAEROSOL, FOAM / TOPICAL4.95 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE / ORAL3 mgExact identifier — unii candidate
34 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
d297abc0-1d4e-654b-e053-2a95a90a886fdca6806f-d900-45f6-8a25-f5ed8fb128fa2021-12-07WarningsExact identifier
spl set id: dca6806f-d900-45f6-8a25-f5ed8fb128fa

Reported adverse events (FAERS/openFDA)#

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