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Diaper Rash Cream 40% ZINC Zinc Oxide 40 g/100g Cream — NDC 77338-0164-01 package photo

Diaper Rash Cream 40% ZINC Zinc Oxide 40 g/100g Cream

by ASTONEA LABS PRIVATE LIMITED · 1 TUBE in 1 BOX (77338-164-01) / 57 g in 1 TUBE
NDC 77338-0164-01
🏷️ FDA NDC (as labeled) 77338-164-01 billing pads the product segment with a zero
This package
Contains57 g in 1 tube Pack sizes2 compare ↓
Also comes in: 71 g 77338-0164-02
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 →

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

FDA NDC (as labeled) 77338-164-01
Product NDC 77338-164
11-digit billing NDC 77338016401
RxCUI 1305337
UNII SOI2LOH54Z
Application # M016
SPL Set ID 16da985a-6210-ec82-e063-6294a90a132d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-03-06
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 77338-164-01 — 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 → 77338-0164-01. 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

LabelerASTONEA LABS PRIVATE LIMITED
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code77338
First marketedMar 2024
Product typeHuman Otc Drug
Portfolio7 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 40 percent zinc oxide, marketed under the FDA's monograph rules for diaper rash products. Zinc oxide is commonly used in skin care preparations to form a protective barrier on the skin surface. It is typically applied to areas affected by diaper rash to help shield irritated skin from moisture and friction.

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.

🧪 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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII BBL281NWFG
    Cod liver oil is a natural oil derived from fish liver that serves as a source of omega-3 fatty acids and vitamins A and D in formulations. It's used as a nutrient supplement ingredient and as an emollient to help soften and smooth the product.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • 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 T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • 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 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.

8 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesPetrolatum, Mineral Oil, Lanolin, Isopropyl Myristate, Beeswax, Tocopheryl Acetate, Cod Liver Oil, Aloe Barbadensis Leaf Juice

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 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.
Try another pack size: 71 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

ProductLabelerPackNADAC/unitTEStatusPrice 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/g 73418-0301-01 Hello 1 tube — — FDA listed —
Diaper Rash Cream 40% ZINC 40 g/100gthis 77338-0164-01 ASTONEA 1 tube — — FDA listed —
MAX BARRIER Skin Protectant 400 mg/mL 82897-0468-00 GL 3.3 ml — — FDA listed —
Burts Bees Baby Bee Diaper Rash 40 g/100g 26052-0028-01 BURT'S 85 g — — FDA listed —
Triple 3x Max Diaper Rash 40 g/100g 16864-0061-01 Advantice 1 tube — — FDA listed —
Best Choice Diaper Rash 40 g/100g 69396-0152-01 Trifecta 113 g — — FDA listed —
Aquaphor Healing Fast Relief Diaper Rash 40 g/100g 10356-0115-10 Beiersdorf 99 g — — FDA listed —
Quality Choice Diaper Rash 40 g/100g 83324-0042-01 Chain 113 g — — FDA listed —
DiaperRashOintment 40 g/100g 68016-0128-20 Pharmacy 113 g — — FDA listed —
Diaper Rash 40 g/100g 87236-0018-04 Aldermed 113 g — — 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

🏛️
2024
On the market since
Mar 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.

🔬 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 Diaper Rash Cream 40% ZINC (this brand).

Top reported reactions

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

Reporter sex

1,941 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization988
Death204
Disabling32
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 272 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
77338-0164-01 You're viewing this 1 TUBE in 1 BOX (77338-164-01) / 57 g in 1 TUBE 2024-03-06 Active
77338-0164-02 71 g in 1 TUBE (77338-164-02) 2024-03-06 Active

Pack size FAQ

What quantity is in NDC 77338-0164-01?
NDC 77338-0164-01 is listed by the FDA — 1 tube in 1 box / 57 g in 1 tube.
What NDC number is used to bill for this package of Diaper Rash Cream 40% ZINC Zinc Oxide 40 g/100g Cream?
Bill NDC 77338-0164-01 — the 11-digit billing format is 77338016401. 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 77338-164-01, 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: 77338-0164-01, written without dashes as 77338016401. 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 77338-0164-01, the first segment (77338) is the labeler code FDA assigned to ASTONEA LABS PRIVATE LIMITED; the middle segment (0164) 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 ASTONEA LABS PRIVATE LIMITED. 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 71 g (77338-0164-02). 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?
ASTONEA LABS PRIVATE LIMITED 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 19 words ▾

Use helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.

⏱️ Dosage and Administration 38 words ▾

Directions change wet and soiled diapers promotly cleanse the diaper area allow to dry apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers will be prolonged

⚠️ Warnings 78 words ▾

Warnings Warnings: For external use only. When using this product When using this product do not get into eyes. Stop use and ask a doctor if condition worsens symtoms 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. Do not use Do not use if tube seal under cap is broken or missing

📦 Storage and Handling 22 words ▾

Other information store at 68º to 77ºF (20º to 25ºC) do not use if tube seal under cap is broken or missing

🧪 Active Ingredient 5 words ▾

Active ingredient Zinc Oxide 40%

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients Petrolatum, Mineral Oil, Lanolin, Isopropyl Myristate, Beeswax, Tocopheryl Acetate, Cod Liver Oil, Aloe Barbadensis Leaf Juice

🎯 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 ↗
← 77338-0162-01 · ASTONEA 77338-0303-52 · ASTONEA →
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.