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AD Overnight Healing 47.2 g/100g Ointment, 431 g — NDC 65197-0404-15 package photo

AD Overnight Healing 47.2 g/100g Ointment, 431 g

by WellSpring Pharmaceutical Corporation · 431 g in 1 JAR (65197-404-15)
NDC 65197-0404-15
🏷️ FDA NDC (as labeled) 65197-404-15 billing pads the product segment with a zero
This package
Contains431 g Pack sizes2 compare ↓
Also comes in: 102 g 65197-0404-04
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

🆔 Identity & classification

FDA NDC (as labeled) 65197-404-15
Product NDC 65197-404
11-digit billing NDC 65197040415
RxCUI 2683093
UNII 4T6H12BN9U
Application # M016
SPL Set ID 57c29db6-da0c-4b28-86c0-6ac1b7122428
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-05-24
Route TOPICAL
Dosage form OINTMENT
Substance PETROLATUM
Why two NDCs? The FDA registers this code as 65197-404-15 — 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 → 65197-0404-15. 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

LabelerWellSpring Pharmaceutical Corporation
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code65197
First marketedMay 2024
Product typeHuman Otc Drug
Portfolio30 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?

AD Overnight Healing is a topical ointment containing petrolatum as its active ingredient. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for ointments in this category rather than undergoing individual product review. Petrolatum is commonly used in skin care products to function as an occlusive moisturizer and protectant, helping to seal in moisture and shield skin from irritants.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 BG4D34CO2H
    Acetoin is a synthetic organic compound used in medicines as a flavoring agent and fragrance component. It gives products a butter or cream-like taste and smell to make them more palatable.
  • UNII TA269SD04T
    Benzaldehyde is an organic compound with a pleasant almond-like smell, used in medicines as a flavoring agent and preservative to improve taste and help prevent microbial spoilage.
  • UNII P0M7O4Y7YD
    A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
  • UNII 5TJD82A1ET
    A cooling crystalline substance made synthetically that is added to medicines as a fragrance, flavoring agent, and mild local irritant to produce a cooling or warming sensation on the skin or mucous membranes.
  • UNII WL0328HX19
    A natural plant-based wax derived from candelilla shrub leaves. It acts as a coating agent, hardener, and texture modifier to control how quickly the medicine releases and to improve the tablet or capsule's appearance and stability.
  • UNII FGL3685T2X
    Chamomile is a plant extract used in medications as a flavoring agent and for its mild soothing properties in formulations. It helps improve taste and aroma of the medicine.
  • 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 2R04ONI662
    Eucalyptus oil is a fragrant liquid extracted from eucalyptus tree leaves. It's used in medicines as a flavor, scent, or soothing agent in topical products and cough preparations.
  • UNII 5Q1I94P4WG
    A fragrant essential oil derived from geranium plants, used as a flavoring and fragrance agent to improve the taste and smell of medicines.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • 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 ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII N6K5787QVP
    Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
  • UNII XOF597Q3KY
    A refined form of wax made from petroleum, microcrystalline wax is used in medicines as a coating agent, binder, and hardening ingredient. It helps give tablets and capsules their shape and protective outer layer.
  • 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 8PI54V663Y
    Oatmeal is ground oat grain used as a natural filler and texture agent in medicines. It absorbs moisture, adds bulk to the formulation, and may help create a soothing base in topical products.
  • UNII I9O0E3H2ZE
    Paraffin is a waxy, petroleum-derived substance used as a coating, lubricant, and hardening agent in tablets and capsules. It helps protect the medicine from moisture and gives pills a smooth finish.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesAcetyl Methyl Carbinol, Avena Sativa (Oat) Kernel Flour, Benzaldehyde, Calendula Officinalis Flower Extract, Camphor, Chamomilla Recutita (Matricaria) Flower Extract, Cod Liver Oil (contains vitamin A & vitamin D), Eucalyptus Oil, Euphorbia Cerifera (Candelilla) Wax, Fragrance (Parfum), Geranium Oil, Glycerin, Lanolin, Lavender Oil, Light Mineral Oil,  Microcrystalline Wax, Paraffin, Potassium Sorbate, Sorbic Acid, Water, White Mineral Oil.

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: 102 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
AD Overnight Healing 47.2 g/100gthis 65197-0404-15 WellSpring 431 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
May 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
65197-0404-04 1 TUBE in 1 BOX (65197-404-04) / 102 g in 1 TUBE 2024-05-24 Active
65197-0404-15 You're viewing this 431 g in 1 JAR (65197-404-15) 2024-11-15 Active

Pack size FAQ

What quantity is in NDC 65197-0404-15?
NDC 65197-0404-15 contains 431 g — 431 g in 1 jar.
What NDC number is used to bill for this package of AD Overnight Healing 47.2 g/100g Ointment?
Bill NDC 65197-0404-15 — the 11-digit billing format is 65197040415. 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 65197-404-15, 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: 65197-0404-15, written without dashes as 65197040415. 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 65197-0404-15, the first segment (65197) is the labeler code FDA assigned to WellSpring Pharmaceutical Corporation; the middle segment (0404) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) 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 WellSpring Pharmaceutical Corporation. 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 1 tube (65197-0404-04). 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?
WellSpring Pharmaceutical 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.

📄 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 30 words ▾

Uses helps treat and prevent diaper rash protects minor skin irritation due to diaper rash and helps seal out wetness helps prevent and temporarily protects chafed, chapped or cracked skin

⏱️ Dosage and Administration 42 words ▾

Directions apply as needed 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 68 words ▾

Warnings For external use only When using this product do not get into eyes do not apply over raw surfaces or blistered areas Stop use and ask a doctor if condition worsens symptoms persist for 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.

📦 Storage and Handling 10 words ▾

Other information store between 20° to 25°C (68° to 77°F)

🧪 Active Ingredient 4 words ▾

Active Ingredients Petrolatum 47.2%

🧪 Inactive Ingredients 58 words ▾

Inactive ingredients Acetyl Methyl Carbinol, Avena Sativa (Oat) Kernel Flour, Benzaldehyde, Calendula Officinalis Flower Extract, Camphor, Chamomilla Recutita (Matricaria) Flower Extract, Cod Liver Oil (contains vitamin A & vitamin D), Eucalyptus Oil, Euphorbia Cerifera (Candelilla) Wax, Fragrance (Parfum), Geranium Oil, Glycerin, Lanolin, Lavender Oil, Light Mineral Oil, Microcrystalline Wax, Paraffin, Potassium Sorbate, Sorbic Acid, Water, White Mineral Oil.

🎯 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 ↗
← 65197-0402-00 · WellSpring 65197-0406-15 · WellSpring →
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.