Baby Diaper Rash Cream Zinc Oxide 400 mg/g Cream
by Hello Bello · 1 TUBE in 1 CARTON (73418-301-01) / 85 g in 1 TUBE
NDC 73418-0301-01
🏷️ FDA NDC (as labeled)
73418-301-01
billing pads the product segment with a zero
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 →
⚠️
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
FDA NDC (as labeled)
73418-301-01
Product NDC
73418-301
11-digit billing NDC
73418030101
RxCUI
1305337
UNII
SOI2LOH54Z
Application #
M016
SPL Set ID
42f14aa6-5694-7727-e063-6294a90a09f3
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2023-10-13
Route
TOPICAL
Dosage form
CREAM
Substance
ZINC OXIDE
Why two NDCs?
The FDA registers this code as 73418-301-01 — 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 → 73418-0301-01. 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.
🏭 Manufacturer & labeler
LabelerHello Bello
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code73418
First marketedOct 2023
Product typeHuman Otc Drug
Portfolio12 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.
🩺 Clinical
🧪 What is this product?
This is an over-the-counter topical cream containing zinc oxide, marketed as a baby diaper rash product under FDA's monograph rules for skin protectants. Zinc oxide is commonly used in diaper rash creams to function as a barrier on the skin, helping to shield the area from moisture and irritation. The cream is applied directly to affected skin and is intended for typical use in managing minor diaper dermatitis.
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.
💬 Questions about Zinc Oxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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UNII 2ZA36H0S2V
Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.
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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 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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UNII Q9L0O73W7L
Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
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UNII 724GKU717M
Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
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UNII K49155WL9Y
Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
-
UNII 3W1JG795YI
Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
-
UNII R0ZB2556P8
Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
8 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesSunflower Seed Oil, Castor Seed Oil, Cera Alba (Beeswax), Cocos Nucifera Oil, Simmondsia Chinensis (Jojoba) Oil, Shea Butter, Tocopherol, Citric Acid
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.
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 |
|---|---|---|---|---|---|---|
| Diaper Rash Cream 2.5oz .4 g/g 57337-0151-01 | Rejoice | 1 tube | — | — | FDA listed | — |
| Diaper Rash Cream 2oz 40 g/100g 57337-0164-01 | Rejoice | 1 tube | — | — | FDA listed | — |
| Diaper Rash Cream 2.5oz 40 g/100g 57337-0165-01 | Rejoice | 1 tube | — | — | FDA listed | — |
| Diaper Rash Cream 15oz 40 g/100g 57337-0169-01 | Rejoice | 425 g | — | — | FDA listed | — |
| Diaper Rash Cream 5.6oz 40 g/100g 57337-0170-01 | Rejoice | 160 g | — | — | FDA listed | — |
| Diaper Rash Cream 2.5oz .4 g/g 58503-0170-01 | China | 1 tube | — | — | FDA listed | — |
| Diaper Rash Cream 5.6oz 40 g/100g 58503-0202-01 | China | 160 g | — | — | FDA listed | — |
| Diaper Rash Cream 15oz 40 g/100g 58503-0205-01 | China | 425 g | — | — | FDA listed | — |
| Earth Baby Diaper Rash Cream 40 g/100g 62588-0904-02 | Earth | 1 tube | — | — | FDA listed | — |
| Baby Diaper Rash Cream 400 mg/gthis 73418-0301-01 | Hello | 1 tube | — | — | FDA listed | — |
| Diaper Rash Cream 40% ZINC 40 g/100g 77338-0164-01 | ASTONEA | 1 tube | — | — | FDA listed | — |
| MAX BARRIER Skin Protectant 400 mg/mL 82897-0468-00 | GL | 3.3 ml | — | — | FDA listed | — |
| CVS Health Diaper Rash 400 mg/g 69842-0058-20 | CVS | 1 tube | — | — | FDA listed | — |
| Dr. Sheffield Diaper Rash 400 mg/g 11527-0058-40 | Sheffield | 1 tube | — | — | FDA listed | — |
| Natureplex Diaper Rash 400 mg/g 67234-0001-01 | Natureplex | 1 tube | — | — | FDA listed | — |
| Walgreens Maximum Diaper Rash 400 mg/g 00363-7280-20 | Walgreens | 1 tube | — | — | FDA listed | — |
| Diaper Rash 400 mg/g 49035-0952-26 | Walmart | 1 tube | — | — | FDA listed | — |
| Desitin Maximum Strength Zinc Oxide Diaper Rash 400 mg/g 69968-0768-01 | Kenvue | 1 tube | — | — | FDA listed | — |
| Diaper Rash 400 mg/g 41250-0412-26 | Meijer, | 1 tube | — | — | FDA listed | — |
| Diaper Rash 400 mg/g 11344-0020-26 | Nice-Pak | 1 tube | — | — | FDA listed | — |
| Diaper Rash 400 mg/g 67091-0020-26 | WinCo | 1 tube | — | — | FDA listed | — |
| Zinc Oxide 400 mg/g 69842-0468-26 | CVS | 1 tube | — | — | FDA listed | — |
| Desitin Maximum Strength Diaper Rash 400 mg/g 69968-0061-01 | Kenvue | 1 tube | — | — | FDA listed | — |
| Diaper Rash 400 mg/g 36800-0020-26 | Topco | 1 tube | — | — | FDA listed | — |
| Diaper Rash 400 mg/g 41163-0020-26 | United | 1 tube | — | — | FDA listed | — |
| Zinc Oxide 400 mg/g 00363-1020-26 | Walgreen | 1 tube | — | — | FDA listed | — |
| Desitin Maximum Strength Zinc Oxide Diaper Rash 400 mg/g 69968-0396-01 | Kenvue | 454 g | — | — | FDA listed | — |
| Desitin Maximum Strength Zinc Oxide Diaper Rash 400 mg/g 69968-0848-01 | Kenvue | 454 g | — | — | FDA listed | — |
| Zinc Oxide 400 mg/g 72288-0989-26 | Amazon.com | 1 tube | — | — | FDA listed | — |
| Diaper Rash 400 mg/g 11673-0020-26 | Target | 1 tube | — | — | Discontinued | — |
| Diaper Rash 400 mg/g 30142-0020-26 | The | 1 tube | — | — | FDA listed | — |
| Diaper Rash 400 mg/g 37808-0020-26 | H | 1 tube | — | — | FDA listed | — |
| Zinc Oxide 400 mg/g 11822-0534-01 | Rite | 1 tube | — | — | FDA listed | — |
| Vitacilina Bebe Diaper Rash 400 mg/g 81929-0002-01 | Taisho | 1 tube | — | — | FDA listed | — |
| Diaper Rash 400 mg/g 55910-0020-26 | Old | 1 tube | — | — | FDA listed | — |
| Zinc Oxide 400 mg/g 72476-0920-26 | ADUSA | 1 tube | — | — | 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
🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 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 Baby Diaper Rash Cream (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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 73418-0301-01 You're viewing this | 1 TUBE in 1 CARTON (73418-301-01) / 85 g in 1 TUBE | 2025-11-06 | Active |
🧭 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 73418-301-01, 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: 73418-0301-01, written without dashes as 73418030101. 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 73418-0301-01, the first segment (73418) is the labeler code FDA assigned to Hello Bello; the middle segment (0301) 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 Hello Bello. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Hello Bello 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
🎯 Indications and Usage ▾
Uses Helps treat and prevent diaper rash Protects chafed skin due to diaper rash and helps seal out wetness
⏱️ Dosage and Administration ▾
Drug Facts Drug Facts
⚠️ Warnings ▾
Warnings For external use only When using this product, do not get into eyes Stop use and ask a doctor if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away
🧪 Active Ingredient ▾
Active Ingredients Zinc Oxide - 40%
🧪 Inactive Ingredients ▾
Inactive Ingredients Sunflower Seed Oil, Castor Seed Oil, Cera Alba (Beeswax), Cocos Nucifera Oil, Simmondsia Chinensis (Jojoba) Oil, Shea Butter, Tocopherol, Citric Acid
🎯 Purpose ▾
Purpose Skin Protectant
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.