FDA.reportPublic FDA data

Family Wellness

Product NDC
55319-108
11-digit product format
553190108
Labeler code
55319
Product ID
55319-108_40ab3bb4-cbc0-b9e1-e063-6294a90a5a0f
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine 20%
Dosage form
GEL
Route
TOPICAL
Labeler
FAMILY DOLLAR SERVICES INC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-01
Substance
BENZOCAINE
Active strength
.2 g/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
Family Wellness
Brand name suffix
Oral Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE.2 g/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
238910Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
105d87d6-9147-43d4-e063-6394a90a57eeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-108-14Family WellnessOral Pain Relief1 in 1 CARTONGEL13
55319-108-14Family WellnessOral Pain Relief14 g in 1 TUBEGEL143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-108FAMILY WELLNESS ORAL PAIN RELIEF (BENZOCAINE 20%) GEL [FAMILY DOLLAR SERVICES INC]2Current NDC, 2 package rows20250112_105d87d6-9147-43d4-e063-6394a90a57ee.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 39 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oral Pain ReliefBENZOCAINEGERI-CARE PHARMACEUTICAL CORPd294a39e-55f4-272d-e053-2995a90ab7f72023-10-31WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.e10c45e6-d37f-4650-b3e5-07719cc0ea492023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.886d949b-8db1-499c-a277-174f8bc29f342023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.fc8194af-2e77-4ad1-ae75-461dce3ed6042023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.baf7d184-07ed-4491-a1fc-9a377b4b01102023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.033034af-c86c-4dbf-90eb-009c117024c62023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.658ada18-2334-4b4e-b08e-702fa127aa142023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.cad932e5-8d7f-4f20-b1c2-febd328152f02023-10-11WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.2c9519ab-320d-49da-9deb-97a6168fb0882023-10-10WarningsExact identifier
application number: M022
IolineBENZOCAINEDharma Research, Inc.b862c974-c024-42c3-986e-b65069437c7b2023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.651ea978-081d-4c59-b177-6049a69d94152023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.db763237-2910-45b9-be72-da092edc951b2023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.34316f93-10b4-41cc-8654-625283f0044c2023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.142a8824-657e-492a-8e5a-b15eb73383c92023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.414cbec9-94e2-4bca-908b-1e79f8db0b272023-10-10WarningsExact identifier
application number: M022
Sore throat cherryPHENOLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)de634cf1-ed39-4d8a-8855-006c69b7aee92023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.e4b2d22b-00b3-45a6-9b7d-8ee7195870592023-10-09WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.a0e284f6-292f-4231-8596-f7cee4e0a12f2023-10-09WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCfe92637a-c88a-f9dd-e053-6294a90a7fa32023-07-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCc979e958-2042-471a-bf03-e84e686201062023-06-20WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSN105d87d6-9147-43d4-e063-6394a90a57ee3
238910benzocaine 0.2 MG/MG Oral GelSCD105d87d6-9147-43d4-e063-6394a90a57ee3
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY105d87d6-9147-43d4-e063-6394a90a57ee3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-108-14553190108141 TUBE in 1 CARTON (55319-108-14) / 14 g in 1 TUBE1 tube2024-02-01NoNoCurrent