Flanders Buttocks White petrolatum, zinc oxide 66.2 g/100g; 13.4 g/100g Ointment, 5 g
by Flanders Inc · 5 g in 1 PACKET (54323-215-03)
NDC 54323-0215-03
🏷️ FDA NDC (as labeled)
54323-215-03
billing pads the product segment with a zero
This package
Contains5 g
Pack sizes2 compare ↓
Also comes in:
113 g 54323-0215-02
OTC
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
54323-215-03
Product NDC
54323-215
11-digit billing NDC
54323021503
UNII
4T6H12BN9U, SOI2LOH54Z
UPC
0081642193442
Application #
M016
SPL Set ID
32371159-c76d-41b0-e054-00144ff88e88
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
1986-10-16
Route
TOPICAL
Dosage form
OINTMENT
Substance
PETROLATUM; ZINC OXIDE
GPI-14
90650000004200
GPI class
Flanders Buttocks
GCN Seq No
005560
GCN
78559
HICL code
002353
Ingredient (HICL)
Balsam Peru/Zinc Oxide
HIC1 code
L
Therapeutic class — broad (HIC1)
Skin/Subcutaneous Tissue
HIC2 code
L6
Therapeutic class — intermediate (HIC2)
Irritants
HIC3 code
L6A
Therapeutic class — specific (HIC3)
Irritants/Counter-Irritants
AHFS code
84:12.00.00
AHFS class
Astringents (84:12)
FDB label name
FLANDERS BUTTOCKS OINTMENT
FDB brand name
Flanders Buttocks Ointment
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 54323-215-03 — a 5-3-2 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 product segment → 54323-0215-03. 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.
🏭 Manufacturer & labeler
LabelerFlanders Inc
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code54323
First marketedOct 1986
Product typeHuman Otc Drug
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 FLANDERS BUTTOCKS OINTMENT Ingredient Balsam Peru/Zinc Oxide
🧪 What is this product?
Flanders Buttocks is a topical ointment containing petrolatum and zinc oxide. This product is an over-the-counter monograph drug, meaning it is marketed under FDA category rules rather than as an individually reviewed new drug application. Petrolatum functions as a skin protectant and moisturizer, while zinc oxide is commonly used as a barrier agent and skin protectant. Together, these ingredients are typically used to help protect and soothe skin in minor irritation and moisture-loss situations.
Patient education
Supplement & herbal interactions
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.
💬 Questions about White petrolatum, zinc oxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
brown
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 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 8P5F881OCY
A natural resin extracted from a South American tree, used as a fragrance, flavor, and mild preservative in medicines. It adds pleasant taste and aroma to products.
-
UNII D5340Y2I9G
Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
-
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 7G1J5DA97F
White wax is a refined, bleached plant-based or mineral wax that serves as a coating and hardening agent in medicines. It helps control how fast the drug dissolves and improves the product's texture and appearance.
4 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statescastor oil, light mineral oil, peruvian balsam, white beeswax
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:
113 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 |
|---|---|---|---|---|---|---|
| Flanders Buttocks 66.2 g/100g; 13.4 g/100gthis 54323-0215-03 | Flanders | 5 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
🏛️
1986
On the market since
Oct 1986
📍
2026
Currently FDA-listed
40 years 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 Flanders Buttocks (this brand).
Top reported reactions
Reporter sex
Male · 67%
Female · 33%
Serious outcomes
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 |
|---|---|---|---|
| 54323-0215-02 | 113 g in 1 TUBE (54323-215-02) | 1993-01-01 | Active |
| 54323-0215-03 You're viewing this | 5 g in 1 PACKET (54323-215-03) | 1986-10-16 | Active |
You're viewing the smallest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 54323-0215-03?
NDC 54323-0215-03 contains 5 g — 5 g in 1 packet.
What is the difference between NDC 54323-0215-03 and NDC 54323-0215-02?
Both are Flanders Buttocks White petrolatum, zinc oxide 66.2 g/100g; 13.4 g/100g Ointment — the drug itself is identical. NDC 54323-0215-03 is the 5 g package, while NDC 54323-0215-02 is the 113 g package.
What NDC number is used to bill for this package of Flanders Buttocks White petrolatum, zinc oxide 66.2 g/100g; 13.4 g/100g Ointment?
Bill NDC 54323-0215-03 — the 11-digit billing format is 54323021503. 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 54323-215-03, 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: 54323-0215-03, written without dashes as 54323021503. 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 54323-0215-03, the first segment (54323) is the labeler code FDA assigned to Flanders Inc; the middle segment (0215) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Flanders 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 113 g (54323-0215-02). 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?
Flanders 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
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
💬 Information for Patients
🎯 Indications and Usage ▾
Uses Helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps protect from wetness
⏱️ Dosage and Administration ▾
Directions change wet and soiled diapers promptly, cleanse the diaper area, allow to dry apply ointment liberally as necessary, with each diaper change, especailly at bedtime or anytime prolonged exposure to wet diapers may be prolonged
⚠️ Warnings ▾
Warnings For External Use only Do not Use over deep puncture wounds, infections, or lacerations. When using this product avoid contact with eyes. Stop use and ask a doctor if condition worsens or does not improve within 7 days
🧪 Active Ingredient ▾
Active Ingredients White Petrolatum 66.2%....................Skin Protectant Zinc Oxide 13.4%..............................Skin Protectant
🧪 Inactive Ingredients ▾
Inactive Ingredients castor oil, light mineral oil, peruvian balsam, white beeswax
🎯 Purpose ▾
Purpose Skin Protectant
💬 Information for Patients ▾
Other Information store at room temperature Lot No. and Exp Date: see crimp of tube may stain clothing
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.