Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Baby Butz Zinc Oxide 17.1 g/57g Cream, 227 g — NDC 52358-0001-3 (Billing 52358-0001-03)
by Olen Skin Care Corporation · 227 g in 1 JAR
This is a package of 227 g of Baby Butz Zinc Oxide 17.1 g/57g Cream from Olen Skin Care Corporation, marketed since Jul 2013 and currently FDA-listed, this package's marketing is listed to end Oct 2027.
NDC 52358-0001-03
🏷️ FDA NDC (as labeled)
52358-0001-3
billing pads the package segment with a zero
This package
Contains227 g
Pack sizes3 compare ↓
🗂️ 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 52358-0001-3 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 52358 labeler · 0001 product · 3 package
- Package marketed since
- Jun 12, 2018
- Package marketing ended
- Oct 1, 2027
- Sample package
- No — commercial package
- Barcode (UPC)
- 0629210201139
- 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)
52358-0001-3
Product NDC
52358-0001
11-digit billing NDC
52358000103
UNII
SOI2LOH54Z
UPC
0629210201139
Application #
M016
SPL Set ID
e6be6b62-13a4-410d-b8ac-457b58fd23da
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2013-07-15
Marketing end
2027-10-01
Route
TOPICAL
Dosage form
CREAM
Substance
ZINC OXIDE
Quick answers
- RxCUI (RxNorm): 1432509
Why two NDCs?
The FDA registers this code as 52358-0001-3 — 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 → 52358-0001-03. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
🧪 What is this product?
Baby Butz Zinc Oxide is an over-the-counter topical cream containing zinc oxide as its active ingredient. This product is marketed under the FDA's monograph rules for its category. Zinc oxide is commonly used in diaper rash creams and barrier products applied to skin to help protect against moisture and irritation. The cream form allows for easy application to affected areas.
Patient education
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
💬 Questions about Zinc Oxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 6, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 52358-0001-01 52358-0001-1 Main listing | 57 g in 1 JAR | 2015-11-02 | Oct 1, 2027 | Active |
| 52358-0001-02 52358-0001-2 | 113 g in 1 JAR | 2015-11-02 | Oct 1, 2027 | Active |
| 52358-0001-03 You're viewing this | 227 g in 1 JAR | 2018-06-12 | Oct 1, 2027 | Active |
You're viewing the largest of 3 pack sizes for this product.
Pack size FAQ
What quantity is in this package?
This package contains 227 g — 227 g in 1 jar.
How does this package differ from NDC 52358-0001-01?
Both are Baby Butz Zinc Oxide 17.1 g/57g Cream — the drug itself is identical. This page's package is the 227 g one, while NDC 52358-0001-01 is the 57 g package.
What NDC number is used to bill for this package of Baby Butz Zinc Oxide 17.1 g/57g Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Baby Butz 17.1 g/57gthis 52358-0001-03 | Olen | 227 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2013
On the market since
Jul 2013
📍
2026
Currently FDA-listed
13 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.
- FDA Orange Book · refreshed Oct 3, 2026
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 4T6H12BN9U
Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
-
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
3 inactive ingredients listed in the exact product block matched to this NDC.
The official label also stateslanolin, petrolatum
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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerOlen Skin Care Corporation
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code52358
First marketedJul 2013
Product typeHuman Otc Drug
Portfolio4 products on file
More NDCs from Olen Skin Care Corporation labeler code 52358
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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 Ask a Doctor Before Use If
📄 When Using This Product
📄 Keep Out of Reach of Children
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Use Helps treat and prevent diaper rash Protects chafed skin due to diaper rash Helps seal out wetness
⏱️ Dosage and Administration ▾
Directions Change wet or soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply cream liberally as often as necessary with each diaper change especially at bedtime or any time exposure to wet diaper my be prolonged.
⚠️ Warnings ▾
Warnings For External Use Only
📦 Storage and Handling ▾
Other Information Store between 15-30 degrees
🧪 Active Ingredient ▾
Active Ingredients Zinc Oxide 30%
🧪 Inactive Ingredients ▾
Inactive Ingredients lanolin, petrolatum
🎯 Purpose ▾
Purpose Skin Protectant
📄 Ask a Doctor Before Use If ▾
If condition worsen or does not improve within 7 days, consult a physician.
📄 When Using This Product ▾
When Using this Product Avoid Contact with eyes.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.
📄 Questions or Comments ▾
Questions? 1-877-494-4313
📄 Package Label / Principal Display Panel ▾
Principal Display Panel Baby Butz Cream Relieves + Prevents Diaper Rash 100% Natural 30% Zinc Oxide Cream Net Wt 4 oz NDC 52358-0001-2 OLEN SKIN CARE CORPORATION MB, CANADA R2E 0M5 babybutz.com label
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 ↗
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 Baby Butz (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 37%
Female · 63%
Unknown · 0%
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.
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 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 it is currently marketed — but Olen Skin Care Corporation has reported a marketing end date of 2027-10-01, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 57 g (52358-0001-01), 113 g (52358-0001-02). 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?
Olen Skin Care Corporation 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.