FDA.reportPublic FDA data

Numstick

Manufacturer
Unit Dose, Ltd.
Effective date
2023-10-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:57:57

Label at a glance#

ProductNumstick
Active ingredientPETROLATUM, LIDOCAINE
Label structure6 sections

Indications and uses

Temporary relief of anorectal discomfort

Dosage and administration

Apply .5-1.0 gm. to desired clean dry area up to 4 times/day as needed.

Label contents#

Full prescribing information#

Active Ingredient in each Gram

OTC - ACTIVE INGREDIENT SECTION

Petrolatum (White) 60%

Lidocaine 5.0%

OTC - PURPOSE SECTION

Skin Protectant

External or Topical Analgesic

USES:

INDICATIONS & USAGE SECTION

Temporary relief of anorectal discomfort

WARNING:

WARNINGS SECTION

External Use Only. Keep out of eyes.. You may develop allergic reaction to ingredients.

Do Not Use:

OTC - DO NOT USE SECTION

More than directed or in the rectum with any mechanical device or applicator.

STOP USE AND ASK A DOCTOR:

OTC - STOP USE SECTION

if pain worsens, or bleeding or swelling occurs

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

and get medical help right away if swallowed.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Apply .5-1.0 gm. to desired clean dry area up to 4 times/day as needed.

INGREDIENTS:

INACTIVE INGREDIENT SECTION

Simmondisa Chinensis (Jojoba) Seed oil, Lanolin, Beeswax, Ozokerite wax, Candelilla wax, Paraffin, Ethoxydiglycol, Menthol, Tocopheryl Acetate, Cholecalciferol, Retinyl Palmitate, Phytonadione

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1733859lidocaine 5 % / petrolatum 60 % Topical StickPSN4
1733859lidocaine 0.05 MG/MG / petrolatum 0.6 MG/MG Topical OintmentSCD4
1733859lidocaine 5 % / petrolatum 60 % Topical OintmentSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16a2c1cd-ae95-d910-f03d-7e06b11dd243Product name520260202
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
653485de-0601-41e4-82db-7a60bb223e27Product name120251024
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
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
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67194-014-01Numstick4 g in 1 TUBESTICK44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67194-014NUMSTICK (PETROLATUM, LIDOCAINE) STICK [UNIT DOSE, LTD.]4Current NDC, Legacy NDC, 1 package rows20231027_127bbd87-5402-4da2-abf3-dac6367735ec.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67194-01467194-014-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
JOJOBA OIL724GKU717MIACT
LANOLIN7EV65EAW6HIACT
YELLOW WAX2ZA36H0S2VIACT
CERESINQ1LS2UJO3AIACT
CANDELILLA WAXWL0328HX19IACT
PARAFFINI9O0E3H2ZEIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
MENTHOLL7T10EIP3AIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CHOLECALCIFEROL1C6V77QF41IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
PHYTONADIONEA034SE7857IACT
PETROLATUM4T6H12BN9UACTIB
LIDOCAINE98PI200987ACTIB

Source Document#

Source XML

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
NumstickPETROLATUM, LIDOCAINEUnit Dose, Ltd.127bbd87-5402-4da2-abf3-dac6367735ec2023-10-18WarningsExact identifier
ndc (package): 67194-014-01
ndc (product): 67194-014
ndc11 (package): 67194001401
spl id: 08052e8d-9708-d5b6-e063-6394a90ae8e0
spl set id: 127bbd87-5402-4da2-abf3-dac6367735ec

Reported adverse events (FAERS/openFDA)#

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