FDA.reportPublic FDA data

Dibucaine Ointment

Manufacturer
Akron Pharma Inc.
Effective date
2025-01-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:52:30

Label at a glance#

ProductDibucaine
Active ingredientDIBUCAINE
Label structure10 sections

Indications and uses

temporanly relieves pain and nching due to hemorrhoids or other anorectal disorders

Dosage and administration

adults and children 12 years and over: if possible, clean the affected area with mild soap and wann water and nnse thoroughly. Dry by patting or blotting withh toilet tissue or a soft cloth before applying. apply externally to the affected area up to 3 or 4 times daily children under 12 years of age: ask a doctor

Storage and handling

Store at room temperature 20 o -25 o C (68 o -77 o F)

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                        Purpose

Dibucaine 1%                  Hemorrhoidal ointment

Uses

OTC - PURPOSE SECTION

temporanly relieves pain and nching due to hemorrhoids or other anorectal disorders

Warninigs

WARNINGS SECTION

For External Use Only

Allergy alert

  • certain persons can develop allergic reactions to ingredients in this product. If the symptoms being treated does not subside or redness, irritation, swelling, bleeding or other symptoms develop or increase, discontinue use and ask a doctor.

Do not use

INDICATIONS & USAGE SECTION

  • in children under 2 years at age
  • in or near the eyes

When using this product

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • avoid contact wnh eyes
  • do not use more than directed unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

lf pregnant or breast feeding, ask a health care professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if

  • bleeding occurs
  • condition worsens or does not improve wnhin 7 days

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over: if possible, clean the affected area with mild soap and wann water and nnse thoroughly. Dry by patting or blotting withh toilet tissue or a soft cloth before applying.
  • apply externally to the affected area up to 3 or 4 times daily
  • children under 12 years of age: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Lanolin, Light Mineral Oil, Purified water, White Petrotalum

STORAGE AND HANDLING SECTION

Store at room temperature 20o-25oC (68o-77oF)

Questions or Comments?

OTC - QUESTIONS SECTION

call toll-free 1(877)225-6999

Manufactured for
Akron Pharma, Inc.,
Fairfeld, NJ - 07004

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1oz1oz

2oz2oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238784dibucaine 1 % Rectal OintmentPSN6
238784dibucaine 0.01 MG/MG Rectal OintmentSCD6
238784dibucaine 1 % Rectal OintmentSY6

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-2829-12023-02-28C16284748780-1f386c64a-3d49-0266-e053-dadaa90a7c1aDibucaine Ointment
71399-2829-22023-02-28C16284748780-1f386c64a-3d49-0266-e053-dadaa90a7c1aDibucaine Ointment
71399-2829-12023-01-30C16284748780-1f386c64a-3d49-0266-e053-dadaa90a7c1aDibucaine Ointment
71399-2829-22023-01-30C16284748780-1f386c64a-3d49-0266-e053-dadaa90a7c1aDibucaine Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-2829-1Dibucaine28 g in 1 TUBEOINTMENT286
71399-2829-2Dibucaine56 g in 1 TUBEOINTMENT566
71399-2829-2Dibucaine1 in 1 PACKAGEOINTMENT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-2829DIBUCAINE OINTMENT [AKRON PHARMA INC.]6Current NDC, Legacy NDC, 3 package rows20250114_60469e43-ab6f-46d3-a1df-00e58275f565.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-2829-1GM - Gram71399-28293f757800-4f65-4c65-be72-d7b496835bb612021-09-07
71399-2829-2GM - Gram71399-2829db3bb464-5bc6-4590-8d1c-c687e77a7b0612021-12-08

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71399-282971399-2829-1, 71399-2829-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIBUCAINEL6JW2TJG99ACTIB
LANOLIN7EV65EAW6HIACT
LIGHT MINERAL OILN6K5787QVPIACT
WATER059QF0KO0RIACT
WHITE PETROLATUMB6E5W8RQJ4IACT

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
DibucaineDIBUCAINEAkron Pharma Inc.60469e43-ab6f-46d3-a1df-00e58275f5652025-01-12WarningsExact identifier
ndc (package): 71399-2829-2
ndc (package): 71399-2829-1
ndc (product): 71399-2829
ndc11 (package): 71399282901
ndc11 (package): 71399282902
spl id: da90939a-75f0-4b82-94ff-8611fe746715
spl set id: 60469e43-ab6f-46d3-a1df-00e58275f565

Reported adverse events (FAERS/openFDA)#

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