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Boudreauxs Baby Shower Bundle Zinc oxide Kit — NDC 00132-0327-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Boudreauxs Baby Shower Bundle Zinc oxide Kit — NDC 0132-0327-01 (Billing 00132-0327-01)

by C.B. Fleet Company, Inc. · 1 KIT in 1 CARTON * 397 g in 1 JAR * 1 TUBE in 1 CARTON / 113 g in 1 TUBE * 57 g in 1 TUBE

This is a package of Boudreauxs Baby Shower Bundle Zinc oxide Kit from C.B. Fleet Company, Inc., marketed since Feb 2024 and currently FDA-listed. It is this product's only package size.

NDC 00132-0327-01
🏷️ FDA NDC (as labeled) 0132-0327-01 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 0132-0327-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0132 labeler · 0327 product · 01 package
Package marketed since
Feb 1, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0132032701 4
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0132-0327-01
Product NDC 0132-0327
11-digit billing NDC 00132032701
Application # M016
SPL Set ID a289ed3c-3c7a-4eda-bf5e-139203d2e17e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-02-01
Dosage form KIT
Why two NDCs? The FDA registers this code as 0132-0327-01 — a 4-4-2 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 labeler segment → 00132-0327-01. 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.

Clinical

🧪 What is this product?

Boudreaux's Baby Shower Bundle is a kit containing zinc oxide, an over-the-counter skin protectant. Zinc oxide is commonly used in diaper rash products and skin barrier creams to help protect and soothe irritated skin. This product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for this category of skin care products rather than being individually reviewed.

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:

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.

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 systemPer eachPer 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.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00132-0327-01 You're viewing this Main listing 1 KIT in 1 CARTON * 397 g in 1 JAR * 1 TUBE in 1 CARTON / 113 g in 1 TUBE * 57 g in 1 TUBE 2024-02-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Eminence Bright Skin Starter Set Kit 15751-3504-00 Eminence 1 kit — — FDA listed —
LIVE TINTED Glow-up Hyperpigmentation Essentials 82153-0280-00 Live 1 kit — — FDA listed —
Dolce AND Gabbana Get Your Healthy Glowy Skin 23648-0116-01 Socoplan 1 kit — — FDA listed —
Gentle Care Kit 69968-0964-09 Kenvue 1 kit — — FDA listed —
Boudreauxs Baby Shower Bundlethis 00132-0327-01 C.B. 1 kit — — 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

🏛️
2024
On the market since
Feb 2024
📍
2026
Currently FDA-listed
2 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.

What it looks like

Color white
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.

From the label’s inactive-ingredient sectionmyroxylon pereiraie (balsam peru) resin, mineral oil, paraffin, petrolatum, ricinus communis (castor) seed oil Alpha-tocopherol actate d- (Vitamin E acetate), castor seed oil, glyceryl hydroxystearate, and hydrogenated castor oil

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerC.B. Fleet Company, Inc.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code00132
First marketedFeb 2024
Product typeHuman Otc Drug
Portfolio23 products on file
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.

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 38 words ▾

Uses Helps treat and prevent diaper rash Protects chafed skin due to diaper rash and helps seal out wetness

Uses Helps treat and prevent diaper rash Protects chafed skin due to diaper rash and helps seal out wetness

⏱️ Dosage and Administration 86 words ▾

Directions Change wet and soiled diaper immediately Cleanse the diaper area and allow to dry Apply ointment liberally and as often as necessary with each diaper change and especially when exposed to wet diapers for a prolonged period of time, such as bedtime

Directions Change wet and soiled diaper immediately Cleanse the diaper area and allow to dry Apply ointment liberally and as often as necessary with each diaper change and especially when exposed to wet diapers for a prolonged period of time, such as bedtime

⚠️ Warnings 98 words ▾

Warnings For external use only When using this product avoid contact with the eyes. Stop use and ask a doctor if condition worsens or does not improve after 7 days. Keep out of the reach of children. If swallowed, seek medical help or call Poison Control Center (1-800-222-1222) immediately.

Warnings For external use only. When using this product avoid contact with the eyes. Stop use and ask a doctor if condition worsens or does not improve after 7 days. Keep out of the reach of children. If swallowed, seek medical help or call Poison Control Center (1-800-222-1222) immediately.

🧪 Active Ingredient 4 words ▾

Active ingredient

Active ingredient

🧪 Inactive Ingredients 33 words ▾

Inactive ingredients myroxylon pereiraie (balsam peru) resin, mineral oil, paraffin, petrolatum, ricinus communis (castor) seed oil

Inactive ingredients Alpha-tocopherol actate d- (Vitamin E acetate), castor seed oil, glyceryl hydroxystearate, and hydrogenated castor oil

🎯 Purpose 10 words ▾

Purpose Zinc oxide, 40%...................................................Skin protectant

Purpose Dimethicone, 1% ...................................................Skin protectant

📄 When Using This Product 18 words ▾

When using this product avoid contact with the eyes.

When using this product avoid contact with the eyes.

📄 Stop Use and Ask a Doctor If 32 words ▾

Stop use and ask a doctor if condition worsens or does not improve after 7 days.

Stop use and ask a doctor if condition worsens or does not improve after 7 days.

📄 Keep Out of Reach of Children 38 words ▾

Keep out of the reach of children. If swallowed, seek medical help or call Poison Control Center (1-800-222-1222) immediately.

Keep out of the reach of children. If swallowed, seek medical help or call Poison Control Center (1-800-222-1222) immediately.

📄 Other Information 52 words ▾

Other information Store at 15°C to 25°C (59°F to 77°F) Remove foil seal prior to use Use with infants, children and adults Will stain clothing and fabric

Other information Store at 15°C to 25°C (59°F to 77°F) Remove foil seal from tube’s tip before use For use with infants, children and adults

📄 Questions or Comments 153 words ▾

Questions or comments 1-855-785-2888 www.buttpaste.com BOUDREAUX’S BUTT PASTE ® Butt Barrier Protective Ointment SKIN PROTECTANT (DIMETHICONE) Drug Facts

Questions or comments 1-855-785-2888 www.buttpaste.com BOUDREAUX’S ® BUTT BRUSH DIAPER CREAM APPLICATOR BPA FREE SILICONE Instructions: Step 1: Apply Butt Paste ® on brush head. Step 2: Gently brush Butt Paste ® on baby’s bottom. For best results, apply thick coat to form a protective barrier.

Step 3: Clean after each use with a baby wipe. Brush can be disinfected in boiling water as needed. It is also dishwasher safe.

Suction cup sticks on almost any surface when changing the diaper. WARNING: The Boudreaux’s Butt Brush ™ is not a toy. Use only as directed.

Discontinue use if skin shows signs of sensitivity or irritation towards the Boudreaux’s Butt Brush ™ . Discard or sterilize the Boudreaux’s Butt Brush ™ in boiling water if comes in contact with yeast infected skin or an infectious rash.

📄 Package Label / Principal Display Panel 91 words ▾

Principal display panel BOUDREAUX’S ® Baby Shower Bundle KIT INCLUDES: -Maximum Strength Boudreaux’s Butt Paste ® -NET WT. 2oz (57 g) -Maximum Strength Boudreaux’s Butt Paste ® - NET WT. 14oz (396 g) -Boudreaux’s Butt Paste Butt Barrier -NET WT.

4 oz (113 g) -Boudreaux’s Butt Brush ™ Principal display panel BOUDREAUX’S® Baby Shower Bundle KIT INCLUDES: -Maximum Strength Boudreaux’s Butt Paste® -NET WT. 2oz (57 g) -Maximum Strength Boudreaux’s Butt Paste®- NET WT. 14oz (396 g) -Boudreaux’s Butt Paste Butt Barrier -NET WT.

4 oz (113 g) -Boudreaux’s Butt Brush™

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

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 Boudreauxs Baby Shower Bundle (this brand).

Top reported reactions

Macular Degeneration460
Pyrexia306
Nausea290
Pain282
Malaise261
Weight Decreased236
Therapeutic Product Effect Incomplete214

Reporter sex

0 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Death204
Life-threatening116
Disabling32
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 272 82
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.

About this NDC listing & data coverage

Over-the-counter (OTC) product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 C.B. Fleet Company, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
C.B. Fleet Company, 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.
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.