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DiaperRashOintment Zinc Oxide 40 g/100g Ointment, 113 g — NDC 68016-0128-20 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

DiaperRashOintment Zinc Oxide 40 g/100g Ointment, 113 g — NDC 68016-128-20 (Billing 68016-0128-20)

by Pharmacy Value Alliance, LLC · 113 g in 1 TUBE

This is a package of 113 g of DiaperRashOintment Zinc Oxide 40 g/100g Ointment from Pharmacy Value Alliance, LLC, marketed since Aug 2016 and currently FDA-listed. It is this product's only package size.

NDC 68016-0128-20
🏷️ FDA NDC (as labeled) 68016-128-20 billing pads the product 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
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) 68016-128-20
Product NDC 68016-128
11-digit billing NDC 68016012820
RxCUI 244638
UNII SOI2LOH54Z
UPC 0840986012723
Application # M016
SPL Set ID 3aace6d8-d24c-00e1-e054-00144ff8d46c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-08-22
Route TOPICAL
Dosage form OINTMENT
Substance ZINC OXIDE
Quick answers
  • RxCUI (RxNorm): 244638
Why two NDCs? The FDA registers this code as 68016-128-20 — 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 → 68016-0128-20. 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?

This is an over-the-counter topical ointment containing zinc oxide, a common skin protectant typically used to help protect and soothe skin affected by diaper rash. Zinc oxide functions as a barrier ingredient that reduces moisture contact with irritated skin. This product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for over-the-counter skin protectants rather than being individually reviewed.

Supplement & herbal interactions

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

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Zinc oxide (OTC drug) (3 interactions) — ranked by severity →
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 gPer 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
68016-0128-20 You're viewing this Main listing 113 g in 1 TUBE 2018-02-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zinc Oxide 40% 40 g/100g 70000-0469-01 Cardinal 1 tube $0.034 — Availability likely —
Dr. Sheffield Diaper Rash 400 mg/g 11527-0058-40 Sheffield 1 tube — — FDA listed —
Zinc Oxide 400 mg/g 11822-0534-01 Rite 1 tube — — FDA listed —
Burts Bees Baby Bee Diaper Rash 40 g/100g 26052-0028-01 BURT'S 85 g — — FDA listed —
Diaper Rash 400 mg/g 30142-0020-26 The 1 tube — — FDA listed —
Diaper Rash 400 mg/g 41163-0020-26 United 1 tube — — FDA listed —
Diaper Rash 400 mg/g 49035-0952-26 Walmart 1 tube — — FDA listed —
Diaper Rash 400 mg/g 67091-0020-26 WinCo 1 tube — — FDA listed —
Natureplex Diaper Rash 400 mg/g 67234-0001-01 Natureplex 1 tube — — FDA listed —
DiaperRashOintment 40 g/100gthis 68016-0128-20 Pharmacy 113 g — — FDA listed —
Best Choice Diaper Rash 40 g/100g 69396-0152-01 Trifecta 113 g — — FDA listed —
CVS Health Diaper Rash 400 mg/g 69842-0058-20 CVS 1 tube — — FDA listed —
Zinc Oxide 400 mg/g 72288-0989-26 Amazon.com 1 tube — — FDA listed —
Vitacilina Bebe Diaper Rash 400 mg/g 81929-0002-01 Taisho 1 tube — — FDA listed —
Quality Choice Diaper Rash 40 g/100g 83324-0042-01 Chain 113 g — — FDA listed —
Diaper Rash 40 g/100g 87236-0018-04 Aldermed 113 g — — FDA listed —
Triple 3x Max Diaper Rash 40 g/100g 16864-0061-01 Advantice 1 tube — — FDA listed —
Diaper Rash Cream 2oz 40 g/100g 57337-0164-01 Rejoice 1 tube — — FDA listed —
Diaper Rash Cream 40% ZINC 40 g/100g 77338-0164-01 ASTONEA 1 tube — — FDA listed —
Diaper Rash Cream 2.5oz 40 g/100g 57337-0165-01 Rejoice 1 tube — — FDA listed —
Diaper Rash Cream 5.6oz 40 g/100g 57337-0170-01 Rejoice 160 g — — FDA listed —
Aquaphor Healing Fast Relief Diaper Rash 40 g/100g 10356-0115-10 Beiersdorf 99 g — — 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 —
Diaper Rash Cream 15oz 40 g/100g 57337-0169-01 Rejoice 425 g — — FDA listed —
Earth Baby Diaper Rash Cream 40 g/100g 62588-0904-02 Earth 1 tube — — FDA listed —
Drs. Pharmacy Baby Healing 40 g/100g 80489-0904-01 OL 50 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

🏛️
2016
On the market since
Aug 2016
📍
2026
Currently FDA-listed
10 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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

LabelerPharmacy Value Alliance, LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code68016
First marketedAug 2016
Product typeHuman Otc Drug
Portfolio26 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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 20 words ▾

Uses Helps treat and prevent diaper rash Protects chafed skin due to diaper rash and helps protect skin from wetness

⏱️ Dosage and Administration 39 words ▾

Directions Change wet and soiled diapers promptly Cleanse the diaper area and allow to dry Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

⚠️ Warnings 13 words ▾

Warnings For External Use Only When using this product Avoid contact with eyes

📦 Storage and Handling 13 words ▾

Other Information: Store at controlled room temperature 20° - 25°C (68° - 77°F)

🧪 Active Ingredient 5 words ▾

Active Ingredient Zinc Oxide 40%

🧪 Inactive Ingredients 29 words ▾

Inactive Ingredients BHA, Cod liver oil (high in vitamin A and D), Frangrance, Lanolin, Mineral Oil, Methylparaben, Petrolatum, Purified water, Talc, Tartrazine yellow #4 (FD and C yellow #4)

🎯 Purpose 3 words ▾

Purpose Skin Protectant

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 DiaperRashOintment (this brand).

Top reported reactions

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

Reporter sex

0 reports
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 270 0
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 Pharmacy Value Alliance, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Pharmacy Value Alliance, LLC 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.
← 68016-0124-30 · CHAIN 68016-0129-12 · Chain →
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.