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Petroleum Skin Protectant White Petrolatum 1 g/g Jelly, 368 g — NDC 00904-5731-82 package photo

Petroleum Skin Protectant White Petrolatum 1 g/g Jelly, 368 g

by Major Pharmaceuticals · 368 g in 1 JAR (0904-5731-82)
NDC 00904-5731-82
🏷️ FDA NDC (as labeled) 0904-5731-82 billing pads the labeler 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 →

🆔 Identity & classification

FDA NDC (as labeled) 0904-5731-82
Product NDC 0904-5731
11-digit billing NDC 00904573182
NCPDP billing unit GM — per gram (weight)
RxCUI 204754
UNII 4T6H12BN9U
Application # M016
SPL Set ID 0e7e11c5-a1f8-43c4-b8a6-211491052404
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-07-11
Route TOPICAL
Dosage form JELLY
Substance PETROLATUM
GPI-14 98600065004050
GPI class White Petroleum Jelly
GCN Seq No 008482
GCN 36369
HICL code 003774
Ingredient (HICL) Petrolatum,White
HIC1 code U
Therapeutic class — broad (HIC1) Miscell. Drugs/ Pharmaceutical Adjuvants
HIC2 code U6
Therapeutic class — intermediate (HIC2) Pharmaceutical Adjuvants
HIC3 code U6E
Therapeutic class — specific (HIC3) Ointment/Cream Bases
AHFS code 96:00.00.00
AHFS class Pharmaceutical Aids
FDB label name WHITE PETROLEUM JELLY
FDB brand name Petroleum Jelly
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0904-5731-82 — a 4-4-2 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 labeler segment → 00904-5731-82. 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

LabelerMajor Pharmaceuticals
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code00904
First marketedJul 2007
Product typeHuman Otc Drug
Portfolio630 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

Label name WHITE PETROLEUM JELLY Ingredient Petrolatum,White
🧪 What is this product?

This is a white jelly applied directly to the skin that contains petrolatum (mineral oil derived from petroleum). Petrolatum is commonly used as a skin protectant and moisturizer to help reduce water loss from the skin surface and protect minor cuts, scrapes, and irritated areas. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for skin protectant products rather than being individually reviewed before marketing.

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.

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.

💲 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.0246 $0.02 / 1 jar
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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
White Petrolatum 1 g/g 70000-0487-01 Cardinal 12 jars $0.007 — Availability likely —
Good Neighbor Petroleum Jelly 100 g/100g 46122-0714-26 AmerisourceBergen 113 g $0.010 — Availability likely —
Petroleum 1 g/g 70677-1235-01 Strategic 106 g $0.013 — Availability likely —
Petroleum Jelly 100 g/100g 00363-0721-04 Walgreens 106 g — — Discontinued —
Walgreens Baby Petroleum 100 g/100g 00363-0731-13 Walgreen 368 g — — FDA listed —
Petroleum Jelly 100 g/100g 00363-1801-06 WALGREENS 212 g — — FDA listed —
Petroleum Jelly 100 g/100g 00363-1804-07 WALGREENS 71 g — — FDA listed —
White Petrolatum 1 g/g 00404-0169-50 Henry 144 packets — — FDA listed —
Petroleum Skin Protectant 1 g/gthis 00904-5731-82 Major 368 g — — FDA listed —
Petroleum 1 g/g 10202-0069-96 7-Select 213 g — — FDA listed —
Petroleum Skin Protectant 1 g/g 11344-0069-10 Nice-Pak 28.3 g — — Discontinued —
Pure petroleum 1 g/g 11673-0069-27 Target 369 g — — Discontinued —
Target Up and Up Petroleum Jelly 100 g/100g 11673-0132-59 TARGET 212 g — — FDA listed —
Pure petroleum 1 g/g 11822-3135-02 Rite 369 g — — FDA listed —
White Rose Petroleum Jelly 1000 mg/g 12022-0031-00 J. 340 g — — FDA listed —
Petroleum Jelly 100 g/100g 13709-0331-01 NeilMed 50 g — — FDA listed —
Petroleum Jelly 100 g/100g 13709-0337-01 NeilMed 368 g — — FDA listed —
Pure petroleum 1 g/g 21130-0069-18 Better 70.8 g — — FDA listed —
Petroleum 1 g/g 30142-0069-07 The 9.9 g — — Discontinued —
Pure Petrolatum Jelly 100 g/100g 30400-0509-01 Jell 368 g — — FDA listed —
Pure petroleum 1 g/g 36800-0069-10 Topco 28.3 g — — Discontinued —
Petroleum 1 g/g 36800-0519-27 Topco 368 g — — FDA listed —
Petroleum 1 g/g 37808-0015-27 H 368 g — — FDA listed —
Petroleum Skin Protectant 1 g/g 37808-0069-27 H 368 g — — FDA listed —
Petroleum 100 g/100g 37808-0519-27 H 368 g — — FDA listed —
Petroleum 1 g/g 37808-0960-18 H 71 g — — FDA listed —
Petroleum 1 g/g 41163-0069-07 United 9.9 g — — Discontinued —
Petroleum Jelly 1 g/g 41226-0817-68 KROGER 368 g — — FDA listed —
Comforts Petroleum Jelly 1 g/g 41226-0820-68 KROGER 368 g — — FDA listed —
Petroleum Skin Protectant 1 g/g 41250-0069-18 Meijer, 70.8 g — — Discontinued —
Petroleum 1 g/g 42507-0069-27 Hy-Vee, 368 g — — FDA listed —
White Petrolatum 1 g/g 43473-0309-01 Nantong 5 g — — FDA listed —
Petroleum Skin Protectant 1 g/g 49035-0038-10 Walmart 28.3 g — — Discontinued —
White Petrolatum 100 g/100g 49035-0518-18 Walmart 70 g — — Discontinued —
Petroleum 1 g/g 50594-0069-27 Big 368 g — — Discontinued —
GoodSense Petroleum Jelly 100 g/100g 50804-0050-04 GOOD 113 g — — FDA listed —
Pure Petrolatum Jelly 100 g/100g 51628-4246-01 MY 368 g — — FDA listed —
Pure Petrolatum Jelly 100 g/100g 51628-4249-01 MY 368 g — — FDA listed —
Pure Petrolatum Jelly 100 g/100g 51628-4600-01 MY 170 g — — FDA listed —
Pure Petrolatum 100 g/100g 51628-5600-01 MY 170 g — — FDA listed —
CAREALL Petroleum 1 g/g 51824-0041-01 New 28.25 g — — FDA listed —
Universal Pure Petroleum 1 g/g 52000-0005-19 Universal 226 g — — FDA listed —
Universal Pure Petroleum Cocoa Butter Scented 1 g/g 52000-0007-19 Universal 226 g — — FDA listed —
Novita Pure Petrolatum Jelly 100 g/100g 52410-1010-03 Shield 226 g — — FDA listed —
Medpride 100 g/100g 52410-3020-02 Shield 5 g — — FDA listed —
Health Smart Original Petroleum 100 g/100g 52862-0013-01 Home 226 g — — FDA listed —
White Rain Original Petroleum 100 g/100g 52862-0131-01 INTERNATIONAL 170 g — — FDA listed —
Petroleum 1 g/g 53329-0068-01 Medline 1 tube — — FDA listed —
Medline 1 g/g 53329-0150-44 Medline 113 g — — FDA listed —
Petroleum Skin Protectant 1 g/g 53942-0069-27 Demoulas 369 g — — FDA listed —
Petroleum 100 g/100g 53942-0519-27 Demoulas 368 g — — FDA listed —
Petroleum Skin Protectant 1 g/g 55301-0069-18 Your 71 g — — Discontinued —
Petroleum Skin Protectant 1 g/g 55319-0069-27 Family 368 g — — Discontinued —
ProCure Petroleum 100 g/100g 55681-0049-02 Twin 56.6 g — — FDA listed —
procure 1 g/g 55681-0211-01 TWIN 5 g — — FDA listed —
Pure petroleum 1 g/g 55910-0069-27 Old 369 g — — FDA listed —
Petroleum Skin Protectant 1 g/g 56062-0069-18 Publix 70.8 g — — FDA listed —
Petroleum 1 g/g 57243-0069-54 Salado 106 g — — FDA listed —
Petroleum Jelly Fragrance Free 3.53oz 100 g/100g 57337-0161-01 Rejoice 100 g — — FDA listed —
White Petrolatum 100 g/100g 57896-0164-14 Geri-Care 144 packets — — FDA listed —
Petrolatum Jelly 100 g/100g 58037-0009-01 NEW 368 g — — FDA listed —
Petroleum 1 g/g 59779-0069-18 CVS 71 g — — FDA listed —
Petroleum with Cocoa 100 g/100g 63868-0599-75 QUALITY 212 g — — FDA listed —
Petroleum 100 g/100g 63868-0601-04 QUALITY 113 g — — FDA listed —
Pure petroleum 1 g/g 63941-0069-27 Valu 368 g — — FDA listed —
Petroleum 100 g/100g 63941-0340-27 Valu 368 g — — FDA listed —
Petroleum Jelly 1 g/g 64772-0202-01 Derma 113 g — — FDA listed —
Vaseline 99.96 g/100g 64942-1866-01 Conopco 368 g — — FDA listed —
Vaseline 99.96 g/100g 64942-1874-01 Conopco 49 g — — FDA listed —
Dawnmist Petroleum 100 g/100g 65517-2020-01 Dukal 56 g — — Discontinued —
Dukal White Petrolatum 1 g/g 65517-2023-01 Dukal 144 packets — — FDA listed —
Lil Drug Store Petroleum Jelly 1 g/g 66715-6835-04 Lil 106 g — — FDA listed —
WinCo FoodsPetroleum Jelly 100 g/100g 67091-0411-13 WinCo 368 g — — FDA listed —
WinCo FoodsPetroleum Jelly 100 g/100g 67091-0412-04 WinCo 113 g — — FDA listed —
White Petrolatum 1 g/g 67777-0005-00 Dynarex 144 packets — — FDA listed —
Petroleum Skin Protectant 1 g/g 68016-0069-27 Pharmacy 369 g — — FDA listed —
White Petrolatum 1 g/g 68786-0211-01 Sion 144 packets — — FDA listed —
White Petrolatum 100 g/100g 69396-0114-05 Trifecta 144 packets — — FDA listed —
Geri-Gentle petrolatum 100 g/100g 69771-0016-12 Geri-gentle 5 g — — FDA listed —
Petroleum 1 g/g 70677-0120-01 Strategic 369 g — — FDA listed —
HealthWise Petroleum Jelly 100 g/100g 71101-0042-04 Veridian 113 g — — FDA listed —
HealthWise Petroleum Jelly Original 100 g/100g 71101-0093-01 Veridian 368 g — — FDA listed —
HealthWise Petroleum Jelly Baby Fresh 100 g/100g 71101-0094-01 Veridian 368 g — — FDA listed —
Caring Mills Petroleum Jelly 100 g/100g 71101-0207-01 Veridian 212 g — — FDA listed —
TheraCare Petroleum Jelly 100 g/100g 71101-0208-01 Veridian 113 g — — FDA listed —
Petroleum 1 g/g 72036-0069-27 Harris 368 g — — FDA listed —
Pharmacys Prescription Petroleum Jelly 99.9 g/100g 72197-0044-06 American 170 g — — FDA listed —
Pharmacys Prescription Petroleum Jelly 99.9 g/100g 72197-0045-06 American 170 g — — Discontinued —
Petroleum 1 g/g 72288-0069-54 Amazon.com 106 g — — FDA listed —
Petrolatum 1 g/g 72476-0069-27 Retail 369 g — — FDA listed —
Petrolatum 1 g/g 72476-0519-27 Retail 368 g — — FDA listed —
Little Me Multipurpose Baby Balm 1000 mg/g 73025-0089-10 Shalom 400 g — — FDA listed —
Petroleum 1 g/g 75981-0069-27 Perrigo 368 g — — FDA listed —
Cars Petroleum 100 g/100g 78495-0003-01 Ultra 113 g — — FDA listed —
Princess Petroleum 100 g/100g 78495-0004-01 Ultra 113 g — — FDA listed —
Meijer Petroleum Jelly 100 g/100g 79481-0007-01 Meijer 368 g — — FDA listed —
Meijer Baby Petroleum Jelly Skin Protectant Frag Free 100 g/100g 79481-0046-01 Meijer 212 g — — FDA listed —
Meijer Baby Petroleum Jelly Skin Protectant Fresh Scent 100 g/100g 79481-0050-01 Meijer 368 g — — FDA listed —
Petroleum 1 g/g 79481-0960-06 Meijer, 213 g — — FDA listed —
Petroleum Jelly 100 g/100g 79903-0183-20 Walmart 566 g — — FDA listed —
Petroleum Jelly 1 g/g 79903-0801-68 WAL-MART 368 g — — FDA listed —
Coconut Milk and Shea Petroleum Jelly 1 g/g 82442-0680-96 Target 212 g — — FDA listed —
Petroleum 100 g/100g 83324-0259-04 QUALITY 113 g — — FDA listed —
Petroleum 100 g/100g 83324-0260-13 QUALITY 368 g — — FDA listed —
Petroleum 100 g/100g 84722-3035-00 VIVE 1 g — — FDA listed —
Pure Petrolatum Jelly 100 g/100g 85114-1010-01 UMENDRA 226 g — — Discontinued —
Pure Petrolatum 100 g/100g 85571-5600-01 VASA 170 g — — FDA listed —
Pharmacys Prescription Petroleum 100 g/100g 85891-0012-01 SPARROW 24 jars — — Discontinued —
Petroleum Jelly 1 g/g 87236-0009-01 Aldermed 1 tube — — FDA listed —
Doue Pure petroleum Original 100 g/100g 87510-0004-01 ONEST 425 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

🏛️
2007
On the market since
Jul 2007
📍
2026
Currently FDA-listed
19 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00904-5731-82, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
3.3K
Units reimbursed last 4 qtrs
1.1M
Gross reimbursed last 4 qtrs
$26.6K
Avg / prescription
$8.05
Avg / unit
$0.0246
Latest quarter Q1 2026
1.1KRx
Fee-for-service vs managed care ⓘ
23% FFS 77% MCO
Fee-for-service · 746 Rx Managed care · 2,560 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 62,916 units · 1,097 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 3,947 units · 20.2 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 50,097 units · 1,183 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 32,032 units · 467 per 100k residents IN Ohio: 335,892 units · 2,850 per 100k residents OH Pennsylvania: 2,710 units · 20.9 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 531,309 units · 7,589 per 100k residents MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 1,363 units · 30.1 per 100k residents KY West Virginia: no data reported WV Virginia: 20,489 units · 235 per 100k residents VA Maryland: 5,926 units · 95.9 per 100k residents MD Connecticut: no data reported CT Rhode Island: 28,034 units · 2,560 per 100k residents RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 5,632 units · 79.0 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
20.27,589
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Massachusetts 7,589 /100k
2 Ohio 2,850 /100k
3 Rhode Island 2,560 /100k
4 Oregon 1,183 /100k
5 Minnesota 1,097 /100k
6 Indiana 467 /100k
7 Virginia 235 /100k
8 Maryland 95.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 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 Petroleum Skin Protectant (this brand).

Top reported reactions

Pyrexia49
Diarrhoea39
Febrile Neutropenia31
Pneumonia29
Anaemia28
Nausea25
Platelet Count Decreased25

Age at onset

Infant1
Child4
Adolescent3
Adult32
Elderly51

Reporter sex

0 reports

Serious outcomes

Hospitalization355
Death114
Life-threatening71
Disabling19
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 39 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
00904-5731-82 You're viewing this 368 g in 1 JAR (0904-5731-82) 2007-07-11 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) — 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) ✓ Available
“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 0904-5731-82, 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: 00904-5731-82, written without dashes as 00904573182. 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 00904-5731-82, the first segment (00904) is the labeler code FDA assigned to Major Pharmaceuticals; the middle segment (5731) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (82) 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 Major Pharmaceuticals. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Major Pharmaceuticals 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 29 words ▾

Uses temporarily protects minor: cuts- scrapes- burns temporarily protects and helps relieve chapped or cracked skin and lips helps protects from the drying effects of wind and cold weather

⏱️ Dosage and Administration 4 words ▾

Directions apply as needed

⚠️ Warnings 5 words ▾

Warnings For external use only

🤒 Adverse Reactions 19 words ▾

ADVERSE REACTION Dist. by MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com Re-order No. 100123 Rev. 03/25 M-97

🧪 Active Ingredient 6 words ▾

Active ingredient White Petrolatum USP (100%)

🧪 Inactive Ingredients 3 words ▾

Inactive ingredient None

🎯 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 ↗
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.