FDA.reportPublic FDA data

Plum Smooth Plumb Numb Gelee

Manufacturer
Universal Companies, Inc. | Filltech USA, LLC
Effective date
2023-11-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:59:42

Label at a glance#

ProductPlum Smooth Plumb Numb Gelee
Active ingredientLIDOCAINE
Label structure10 sections

Indications and uses

For the temporary relief of discomfort and pain

Dosage and administration

Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of discomfort and pain

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily

Warnings

WARNINGS SECTION

For external use only

Avoid contact with eyes

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Do not use

OTC - DO NOT USE SECTION

In large quantities, particularly over raw surfaces or blistered areas

OTC - STOP USE SECTION

  • skin becomes irritated
  • condition worsens or symptoms last more than 7 days
  • symptoms clear up and reoccur within a few days

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Diazolidinyl Urea, Disodium EDTA, Glycerin, Menthol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, SD Alcohol 40-2, Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine

Distributed by:

SPL UNCLASSIFIED SECTION

Universal Companies, Inc. Abingdon, VA 24210

Plum Smooth Plumb Numb Gelee 1oz/28.35g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PlumSmoothLabelPlumSmoothLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1291672lidocaine 4 % Topical GelPSN3
1291672lidocaine 0.04 MG/MG Topical GelSCD3
1291672lidocaine 4 % Topical GelSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49911-884-01Plum Smooth Plumb Numb Gelee28.35 g in 1 BOTTLEGEL28.353

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49911-884PLUM SMOOTH PLUMB NUMB GELEE (LIDOCAINE) GEL [UNIVERSAL COMPANIES, INC.]3Current NDC, Legacy NDC, 1 package rows20231110_6be7d8e0-6cd0-4da2-926f-3dbb3db3bd8e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI2009871
LIDOCAINEACTIVE MOIETY98PI2009871
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YD1
CAMELLIA SINENSIS FLOWERINACTIVE INGREDIENT9I2BJY2J171
COMFREY LEAFINACTIVE INGREDIENTDG4F8T839X1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW41
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
MATRICARIA CHAMOMILLA WHOLEINACTIVE INGREDIENT2Z4LRR776S1
MENTHOLINACTIVE INGREDIENTL7T10EIP3A1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49911-88449911-884-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CAMELLIA SINENSIS FLOWER9I2BJY2J17IACT
MATRICARIA CHAMOMILLA WHOLE2Z4LRR776SIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
COMFREY LEAFDG4F8T839XIACT
TROLAMINE9O3K93S3TKIACT
LIDOCAINE98PI200987ACTIB

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 1 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4LOTION / TOPICAL3 %w/wExact identifier — unii+route
6 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / TOPICAL4 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4CREAM / TOPICAL29 mgExact identifier — unii+route
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4CREAM / TOPICAL29 mgExact identifier — unii+route
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4OINTMENT / TOPICAL0.1 %w/wExact identifier — unii+route
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4LOTION / TOPICAL3 %w/wExact identifier — unii+route
6 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4OINTMENT / TOPICAL0.1 %w/wExact identifier — unii+route
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / TOPICAL4 mgExact identifier — unii+route+dosage form
2 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
Plum Smooth Plumb Numb GeleeLIDOCAINEUniversal Companies, Inc.6be7d8e0-6cd0-4da2-926f-3dbb3db3bd8e2023-11-09WarningsExact identifier
ndc (package): 49911-884-01
ndc (product): 49911-884
ndc11 (package): 49911088401
spl id: 09c29a75-1493-1335-e063-6394a90a7f27
spl set id: 6be7d8e0-6cd0-4da2-926f-3dbb3db3bd8e

Reported adverse events (FAERS/openFDA)#

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