FDA.reportPublic FDA data

Dental Relief

Product NDC
68421-8100
11-digit product format
684218100
Labeler code
68421
Product ID
68421-8100_d33a6568-11e9-426b-8eb0-0cfd44ede2ff
Type
HUMAN OTC DRUG
Nonproprietary name
benzocaine
Dosage form
LIQUID
Route
TOPICAL
Labeler
Cintas First Aid & Safety
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-05-06
Substance
BENZOCAINE
Active strength
200 mg/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Dental Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308657Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9068a54-6123-4715-b025-a5bdb4d5c702Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68421-8100-2Dental Relief0.5 g in 1 PACKETLIQUID0.54
68421-8100-3Dental Relief10 in 1 BAGLIQUID104
68421-8100-4Dental Relief500 in 1 BOXLIQUID5004

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
benzocaineACTIVE INGREDIENTU3RSY48JW5DENTAL RELIEF (BENZOCAINE) LIQUID [CINTAS FIRST AID & SAFETY]3
benzocaineACTIVE MOIETYU3RSY48JW5DENTAL RELIEF (BENZOCAINE) LIQUID [CINTAS FIRST AID & SAFETY]3
peppermint oilINACTIVE INGREDIENTAV092KU4JHDENTAL RELIEF (BENZOCAINE) LIQUID [CINTAS FIRST AID & SAFETY]3
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PDENTAL RELIEF (BENZOCAINE) LIQUID [CINTAS FIRST AID & SAFETY]3
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQDENTAL RELIEF (BENZOCAINE) LIQUID [CINTAS FIRST AID & SAFETY]3
saccharin sodium dihydrateINACTIVE INGREDIENTSB8ZUX40TYDENTAL RELIEF (BENZOCAINE) LIQUID [CINTAS FIRST AID & SAFETY]3
sorbic acidINACTIVE INGREDIENTX045WJ989BDENTAL RELIEF (BENZOCAINE) LIQUID [CINTAS FIRST AID & SAFETY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68421-8100DENTAL RELIEF (BENZOCAINE) LIQUID [CINTAS FIRST AID & SAFETY]4Current NDC, Legacy NDC, 3 package rows20160714_d9068a54-6123-4715-b025-a5bdb4d5c702.zip

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
Dental ReliefBENZOCAINECintas First Aid & Safetyd9068a54-6123-4715-b025-a5bdb4d5c7022014-02-27WarningsExact identifier
ndc (product): 68421-8100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308657benzocaine 20 % Mucous Membrane Topical SolutionPSNd9068a54-6123-4715-b025-a5bdb4d5c7024
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCDd9068a54-6123-4715-b025-a5bdb4d5c7024
308657benzocaine 20 % Mucous Membrane Topical SolutionSYd9068a54-6123-4715-b025-a5bdb4d5c7024

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68421-8100-2684218100020.5 g in 1 PACKET0.5 gHistorical
68421-8100-36842181000310 PACKET in 1 BAG (68421-8100-3) / .5 g in 1 PACKET (68421-8100-2) 10 packet2016-05-060000-00-00NoNoCurrent
68421-8100-468421810004500 PACKET in 1 BOX (68421-8100-4) / .5 g in 1 PACKET (68421-8100-2) 500 packet2016-05-060000-00-00NoNoCurrent