FDA.reportPublic FDA data

Numpot Topical Anesthetic

Manufacturer
Unit Dose, Ltd.
Effective date
2023-10-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:57:59

Label at a glance#

ProductNumpot Topical Anesthetic
Active ingredientLIDOCAINE, PETROLATUM
Label structure7 sections

Indications and uses

Temporarily relieves local discomfort, pain and Swelling, or burning associated with anorectal disorders.

Dosage and administration

Apply sparingly to affected area as often as needed up to 6 times daily. ​STORE IN COOL DARK AREA.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%

Petrolatum 71%

PURPOSE

OTC - PURPOSE SECTION

Anesthetic

Skin Protectant

USES:

INDICATIONS & USAGE SECTION

Temporarily relieves local discomfort, pain and Swelling, or burning associated with anorectal disorders.

WARNING:

WARNINGS SECTION

External use only. Keep out of eyes. Allergic reactions can occur.

STOP USE & ASK A DOCTOR:

OTC - STOP USE SECTION

If condition worsens or does not improve within 7 days

  • If redness, irritation, pain, swelling or other symptoms develop or increase
  • If bleeding occurs.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center ASAP.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Apply sparingly to affected area as often as needed up to 6 times daily.

​STORE IN COOL DARK AREA.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Mineral Oil, Lanolin Alcohol, Polysorbate 60, Paraffin, Sorbitan Oleate, Tocopheryl Acetate (Vit. E Acetate), Aloe Barbadensis (Organic Aloe Vera) leaf juice, Cholecalciferol (Vit. D3), Phytonadione (Vit. K1)

Questions?

OTC - QUESTIONS SECTION

Call us at Toll Free (888)664-9990

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label1Label1Label2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1733863lidocaine 5 % / petrolatum 71 % Rectal OintmentPSN4
1733863lidocaine 0.05 MG/MG / petrolatum 0.71 MG/MG Rectal OintmentSCD4
1733863lidocaine 5 % / petrolatum 71 % Rectal 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
67194-018-01Numpot Topical Anesthetic28 g in 1 JAROINTMENT284

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67194-018NUMPOT TOPICAL ANESTHETIC (LIDOCAINE, PETROLATUM) OINTMENT [UNIT DOSE, LTD.]4Current NDC, Legacy NDC, 1 package rows20231027_9143b50b-7d76-4545-aa2e-1bb77ffb44ae.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67194-01867194-018-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPIACT
LANOLIN ALCOHOLS884C3FA9HEIACT
POLYSORBATE 60CAL22UVI4MIACT
PARAFFINI9O0E3H2ZEIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
CHOLECALCIFEROL1C6V77QF41IACT
PHYTONADIONEA034SE7857IACT
LIDOCAINE98PI200987ACTIB
PETROLATUM4T6H12BN9UACTIB

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
Numpot Topical AnestheticLIDOCAINE, PETROLATUMUnit Dose, Ltd.9143b50b-7d76-4545-aa2e-1bb77ffb44ae2023-10-19WarningsExact identifier
ndc (package): 67194-018-01
ndc (product): 67194-018
ndc11 (package): 67194001801
spl id: 0814bc6d-5504-8353-e063-6394a90a0e16
spl set id: 9143b50b-7d76-4545-aa2e-1bb77ffb44ae

Reported adverse events (FAERS/openFDA)#

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