NDC 71399-2829-01 — Dibucaine .28 g/28g Ointment, 28 g

🆔 Identity & classification

FDA NDC (as labeled) 71399-2829-1

Product NDC 71399-2829

11-digit billing NDC 71399282901

NCPDP billing unit GM — per gram (weight)

RxCUI 238784

UNII L6JW2TJG99

Application # M015

SPL Set ID 60469e43-ab6f-46d3-a1df-00e58275f565

Established class (EPC) Standardized Chemical Allergen

Physiologic effect Increased Histamine Release; Cell-mediated Immunity

Chemical class Allergens

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2025-01-06

Route TOPICAL

Dosage form OINTMENT

Substance DIBUCAINE

GPI-14 89200017004210

GPI class Dibucaine (Perianal)

GCN Seq No 007484

GCN 30730

HICL code 002979

Ingredient (HICL) Dibucaine

HIC1 code Q

Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other

HIC2 code Q5

Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin

HIC3 code Q5H

Therapeutic class — specific (HIC3) Topical Local Anesthetics

AHFS code 84:08.00.00

AHFS class Antipruritics And Local Anesthetics

FDB label name DIBUCAINE 1% OINTMENT

FDB brand name Dibucaine

Legend status O — Over-the-counter (OTC) drug or device

Why two NDCs? The FDA registers this code as 71399-2829-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 71399-2829-01. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Standardized Chemical Allergen class.

Pharmacologic class Standardized Chemical Allergen

Drug family (ATC) Local anesthetics, Anesthetics for topical use, Amides

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAkron Pharma Inc.

FDA applicationM015 (OTC MONOGRAPH DRUG)

Labeler code71399

First marketedJan 2025

Product typeHuman Otc Drug

Portfolio44 products on file

🔎 All NDCs from Akron Pharma Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name DIBUCAINE 1% OINTMENT Ingredient Dibucaine

🧪 What is this product?

Dibucaine 0.28 percent ointment is a topical over-the-counter product marketed under FDA's OTC monograph rules for topical anesthetics. Dibucaine is a local anesthetic typically used to numb minor skin irritations and provide temporary relief from itching and pain on the surface of the skin. This ointment is applied directly to the affected area and works by reducing nerve signal transmission in that region.

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII 7EV65EAW6H
Lanolin is a waxy substance derived from sheep's wool. It's used in medicines as an emollient and skin-conditioning agent to soften formulations and improve spreadability in topical products like creams and ointments.
UNII N6K5787QVP
Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
UNII B6E5W8RQJ4
White petrolatum is a purified mineral oil product used as a lubricant and skin protectant in medications. It helps pills slide through manufacturing equipment and can soften or protect the skin when applied topically.

4 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesLanolin, Light Mineral Oil, Purified water, White Petrotalum

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per g	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Try another pack size: 56 g

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
CVS Topical Analgesic Hemorrhoidal 10 mg/mL 51316-0207-28	CVS	28 ml	—	—	FDA listed	—
Dibucaine 1 g/100g 69396-0023-01	Trifecta	1 tube	—	—	FDA listed	—
Dibucaine .28 g/28gthis 71399-2829-01	Akron	28 g	—	—	FDA listed	—

About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2025

On the market since

Jan 2025

📍

2026

Currently FDA-listed

1 year listed

🔒

·

No generic listed yet

brand only

ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Dibucaine — the ingredient across all brands.

Top reported reactions

Back Pain19

Malaise18

Nausea16

Blood Pressure Increased15

Crohn^s Disease15

Anxiety14

Blood Pressure Systolic Increased14

Age at onset

Adolescent1

Adult15

Elderly6

Reporter sex

Male · 47%

Female · 53%

Serious outcomes

Hospitalization50

Death6

Life-threatening3

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
71399-2829-01 You're viewing this	28 g in 1 TUBE (71399-2829-1)	2021-11-04	Active
71399-2829-02	1 TUBE in 1 PACKAGE (71399-2829-2) / 56 g in 1 TUBE	2021-11-04	Active

Pack size FAQ

What quantity is in NDC 71399-2829-01?

NDC 71399-2829-01 contains 28 g — 28 g in 1 tube.

What NDC number is used to bill for this package of Dibucaine .28 g/28g Ointment?

Bill NDC 71399-2829-01 — the 11-digit billing format is 71399282901. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?

An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 71399-2829-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71399-2829-01, written without dashes as 71399282901. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 71399-2829-01, the first segment (71399) is the labeler code FDA assigned to Akron Pharma Inc.; the middle segment (2829) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Akron Pharma Inc.. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tube (71399-2829-02). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Akron Pharma Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 15 words ▾

Do not use in children under 2 years at age in or near the eyes

⏱️ Dosage and Administration 59 words ▾

Directions 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

⚠️ Warnings 43 words ▾

Warninigs 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.

📦 Storage and Handling 14 words ▾

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

🧪 Active Ingredient 9 words ▾

Drug Facts Active ingredient Purpose Dibucaine 1% Hemorrhoidal ointment

🧪 Inactive Ingredients 10 words ▾

Inactive Ingredients Lanolin, Light Mineral Oil, Purified water, White Petrotalum

🎯 Purpose 13 words ▾

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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Dibucaine NDCsSame ingredient 🏭 All Akron labeler NDCsLabeler code 71399 📚 All Standardized Chemical Allergen NDCsDrug class 📖 Read the Dibucaine drug informationUses, warnings & side effects

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Topical Local Anesthetics.

Pramoxine Hcl 00316-0230-75 Dyclonine Hcl 00362-3971-05 Lidocaine Hcl 00536-1139-20 Tetracaine/Benzocaine/Butamben 10223-0201-03 Benzocaine 16864-0640-01 Benzocaine/Benzethon Cl 16864-0670-01 Benzocaine/Menthol 16864-0680-01 Lidocaine 24357-0701-06 Lidocaine/Aloe Vera 46122-0555-28 Lidocaine/Menthol 46122-0574-21 Lidocaine Hcl/Benzalkonium Chl 46122-0656-25 Benzocaine/Resorcinol 63868-0949-01 Dyclonine Hcl/Benzethonium Cl 70000-0599-01

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.