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CVS Health Vitamin A and D Skin Protectant lanolin and petrolatum 155 mg/g; 534 mg/g Ointment, 454 g — NDC 51316-0399-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CVS Health Vitamin A and D Skin Protectant lanolin and petrolatum 155 mg/g; 534 mg/g Ointment, 454 g — NDC 51316-399-01 (Billing 51316-0399-01)

by CVS Health · 454 g in 1 JAR

This is a package of 454 g of CVS Health Vitamin A and D Skin Protectant lanolin and petrolatum 155 mg/g; 534 mg/g Ointment from CVS Health, marketed since Apr 2010 and currently FDA-listed. It is this product's only package size.

NDC 51316-0399-01
🏷️ FDA NDC (as labeled) 51316-399-01 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 →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51316-399-01
Product NDC 51316-399
11-digit billing NDC 51316039901
RxCUI 664981
UNII 7EV65EAW6H, 4T6H12BN9U
Application # M016
SPL Set ID fe3ccabb-9644-4091-9dca-ffd96a43ecaf
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-04-29
Route TOPICAL
Dosage form OINTMENT
Substance LANOLIN; PETROLATUM
Quick answers
  • RxCUI (RxNorm): 664981
Why two NDCs? The FDA registers this code as 51316-399-01 — 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 → 51316-0399-01. 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.

Clinical

🧪 What is this product?

This is an over-the-counter topical ointment containing lanolin and petrolatum as skin-protectant ingredients. Lanolin and petrolatum are typically used together in products meant to help protect and soften dry or irritated skin by forming a moisturizing barrier on the skin surface. This product is marketed under the FDA's over-the-counter monograph rules for skin protectants rather than as an individually approved drug application.

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
51316-0399-01 You're viewing this Main listing 454 g in 1 JAR 2010-04-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
LDR Vitamans A and D 53.4 g/100g; 15.5 g/100g 70000-0358-01 Cardinal 425 g $0.013 — Availability likely —
Walgreens Vitamin A and D skin protectant 53.4 g/100g; 15.5 g/100g 00363-0582-26 Walgreen 1 tube — — FDA listed —
First Aid A and D 15.5 g/100g; 53.4 g/100g 00363-5362-07 Walgreen 1 tube — — FDA listed —
Baby Vitamin A and D 15.5 g/100g; 53.4 g/100g 00363-6253-07 Walgreen 1 tube — — FDA listed —
Target Vitamin A and D Diaper Rash 534 mg/g; 155 mg/g 11673-0721-40 Target 1 tube — — FDA listed —
Lanolin, Petrolatum 155 mg/g; 534 mg/g 11822-0103-04 Rite 1 tube — — FDA listed —
Skin Protectant for Babies and kids 155 mg/g; 534 mg/g 13709-0352-01 Neilmed 1 tube — — FDA listed —
Vitamin A D 155 mg/g; 534 mg/g 30142-0022-26 Kroger 1 tube — — FDA listed —
Jell with Vitamin A D 53.4 g/100g; 15.5 g/100g 30400-0215-10 Jell 1 tube — — FDA listed —
Vitamin A D 155 mg/g; 534 mg/g 36800-0017-26 Topco 1 tube — — FDA listed —
Vitamin A D 155 mg/g; 534 mg/g 41250-0091-26 Meijer, 1 tube — — FDA listed —
CVS Health Vitamin A and D Skin Protectant 155 mg/g; 534 mg/gthis 51316-0399-01 CVS 454 g — — FDA listed —
Kidgets Baby Petroleum Jelly with Vitamin A D 53.4 g/100g; 15.5 g/100g 51628-4248-01 MY 113 g — — FDA listed —
Vitamin A and D 15.5 g/100g; 53.4 g/100g 55319-0103-01 Family 113 g — — FDA listed —
Vitamin A and D 53.4 g/100g; 15.5 g/100g 55319-0603-01 MIDWOOD 113 g — — FDA listed —
Gentle STEPS vitamins A and D Diaper Rash and Skin Protectant 15.5 g/100g; 53.4 g/100g 55910-0805-72 Old 1 tube — — FDA listed —
Multi-Purpose Skin Protectant 53.4 g/100g; 15.5 g/100g 59779-0841-03 CVS 1 tube — — FDA listed —
AD First Aid Multipurpose 53.4 g/100g; 15.5 g/100g 65197-0400-10 WellSpring 1 tube — — FDA listed —
AD PREVENT Original 15.5 g/100g; 53.4 g/100g 65197-0401-00 WellSpring 454 g — — FDA listed —
AD Anti-Chafing 15.5 g/100g; 53.4 g/100g 65197-0408-15 WellSpring 1 tube — — FDA listed —
AD Skin Protectant 15.5 g/100g; 53.4 g/100g 65197-0470-16 WellSpring 454 g — — FDA listed —
FDS intimate Whole Body Medicated Chafing 15.5 g/100g; 53.4 g/100g 65197-0730-15 WellSpring 1 tube — — FDA listed —
A and D Diaper Rash and Skin Protectant .15 mg/g; .53 mg/g 67234-0030-01 Natureplex 1 tube — — FDA listed —
Vitamin A and D 53.4 g/100g; 15.5 g/100g 69396-0009-20 Trifecta 1 tube — — FDA listed —
Vitamin A and D 15.5 g/100g; 53.4 g/100g 69396-0018-05 Trifecta 1 tube — — FDA listed —
Lanolin, Petrolatum 155 mg/g; 534 mg/g 69842-0488-26 CVS 1 tube — — FDA listed —
TheraCare A and D 15.5 g/100g; 53.4 g/100g 71101-0013-01 Veridian 1 tube — — FDA listed —
mama bear DIAPER RASH Skin Protectant 155 mg/g; 534 mg/g 72288-0342-01 AMAZON.COM 454 g — — FDA listed —
Vitamin A D 534 mg/g; 155 mg/g 79903-0328-04 Walmart 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

🏛️
2010
On the market since
Apr 2010
📍
2026
Currently FDA-listed
16 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.

What it looks like

Color yellow
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 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 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 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 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.

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

The official label also stateswater, sodium laureth sulfate, cocamide MEA, cocamidopropyl betaine, laureth-4, fragrance, polysorbate 20, citric acid, sodium chloride, disodium EDTA, phenoxyethanol, methylchloroisothiazolinone, methylisothiazolinone, red 40, blue 1, yellow 5, yellow 6.

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.

Manufacturer & labeler

LabelerCVS Health
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code51316
First marketedApr 2010
Product typeHuman Otc Drug
Portfolio50 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 9 words ▾

Use controls the symptom of: dandruff seborrheic dermatitis psoriasis

⏱️ Dosage and Administration 36 words ▾

Directions for best results use at least twice a week or as directed by a doctor wet hair thoroughly massage shampoo into the scalp lather, leave on hair and scalp for several minutes. rinse and repeat

⚠️ Warnings 142 words ▾

Warnings For external use only. Ask a doctor before use if you have a condition that covers a large area of the body. When using this product avoid contact with the eyes.

If contact occurs, rinse eyes thoroughly with water use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application. do not use for prolonged periods without consulting a doctor. do not use this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📦 Storage and Handling 20 words ▾

Other information store away from direct sunlight in rare instances, discoloration of gray, blonde, bleached or tinted hair may occur

🧪 Active Ingredient 10 words ▾

Active ingredient Solubilized Coal Tar Extract 2.50% (Coal Tar, 0.50%)

🧪 Inactive Ingredients 31 words ▾

Inactive ingredients water, sodium laureth sulfate, cocamide MEA, cocamidopropyl betaine, laureth-4, fragrance, polysorbate 20, citric acid, sodium chloride, disodium EDTA, phenoxyethanol, methylchloroisothiazolinone, methylisothiazolinone, red 40, blue 1, yellow 5, yellow 6.

🎯 Purpose 5 words ▾

Purpose Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis

📄 Ask a Doctor Before Use If 18 words ▾

Ask a doctor before use if you have a condition that covers a large area of the body.

📄 When Using This Product 78 words ▾

When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application. do not use for prolonged periods without consulting a doctor. do not use this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor.

📄 Stop Use and Ask a Doctor If 21 words ▾

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-866-567-8600

📄 Package Label / Principal Display Panel 61 words ▾

PRINCIPAL DISPLAY PANEL - 251 mL Bottle Label NDC 0904-5259-44 MAJOR ® Thera-Gel™ THERAPEUTIC SHAMPOO ORIGINAL FORMULA Coal Tar 0.5% Long Lasting Relief of Itching and Flaking Controls the Symptoms of: Seborrheic Dermatitis Psoriasis Dandruff 05-1439A *Compare to the active ingredient of Neutrogena ® T/Gel ® Therapeutic Shampoo

8.5 FL OZ (251 mL) PRINCIPAL DISPLAY PANEL - 251 mL Bottle Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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: this package is listed as actively marketed, with no marketing end date reported by CVS Health. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CVS Health 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.