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OKeeffes Lip Repair SEAL and HEAL Petrolatum 30 g/100g Stick, 2 cylinders — NDC 71564-0011-22 package photo

OKeeffes Lip Repair SEAL and HEAL Petrolatum 30 g/100g Stick, 2 cylinders

by The Gorilla Glue Company/O'Keeffe's Company · 2 CYLINDER in 1 BLISTER PACK (71564-011-22) / 4.2 g in 1 CYLINDER
NDC 71564-0011-22
🏷️ FDA NDC (as labeled) 71564-011-22 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 13, 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) 71564-011-22
Product NDC 71564-011
11-digit billing NDC 71564001122
RxCUI 417854
UNII 4T6H12BN9U
Application # M016
SPL Set ID 55f66f54-da39-76c7-e063-6394a90aeda9
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-22
Route TOPICAL
Dosage form STICK
Substance PETROLATUM
Why two NDCs? The FDA registers this code as 71564-011-22 — 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 → 71564-0011-22. 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

LabelerThe Gorilla Glue Company/O'Keeffe's Company
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code71564
First marketedJul 2026
Product typeHuman Otc Drug
Portfolio5 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?

O'Keeffe's Lip Repair SEAL and HEAL is a topical lip balm stick containing petrolatum as its active ingredient. Petrolatum is an occlusive moisturizer commonly used in over-the-counter lip care products to help seal in moisture and protect the lip surface from drying conditions. This product is marketed as an OTC monograph drug, meaning it follows FDA's established standards for this category of lip balms rather than undergoing individual product review.

Supplement & herbal interactions

Some supplements/herbs that may interact with Petrolatum — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Petrolatum (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 R9TPS68K19
    A synthetic crosslinked polymer derived from adipic acid and diglycol that acts as a thickener and gelling agent. It increases the viscosity and texture of liquid or semi-solid formulations to improve consistency and stability.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 9E4CO0W6C5
    A silicone-based polymer that forms soft, spongy particles. Used as a texture modifier and suspending agent to improve how the product feels and flows, and to help keep ingredients evenly distributed throughout the formulation.
  • UNII 4YI0729529
    A synthetic oil made from plant-derived hydrocarbons that has been chemically saturated. It acts as a lubricant and glidant to help the medicine flow smoothly during manufacturing and improve tablet handling.
  • UNII 2PXE57RY69
    Menthyl nicotinate is a chemical compound combining menthol and niacin (vitamin B3). In medicines, it acts as a skin penetration enhancer and may provide a cooling or warming sensory effect, sometimes used in topical formulations for local delivery.
  • UNII 255PIF62MS
    A synthetic antioxidant compound used to prevent oils and fats in medications from breaking down or becoming rancid during storage. It helps maintain the medicine's stability and shelf life.
  • UNII 66YXD4DKO9
    A natural oil extracted from almond kernels. It's used in medicines as an emollient and solvent to help dissolve or suspend active ingredients and improve texture in topical and oral formulations.
  • UNII 0UI45XV0T6
    A plant oil extracted from pomegranate seeds. It's used in formulations as an emollient to soften and smooth the product texture, and sometimes as a carrier or conditioning agent in topical preparations.
  • UNII I4807BK602
    Saccharin sodium anhydrous is an artificial sweetener derived from saccharin that contains no water. It's added to medicines to improve taste and make them easier to swallow, especially in liquid formulations and chewable tablets.
  • UNII H58HX2GWJ5
    A synthetic rubber made from styrene and isoprene monomers. It serves as a film-former and binder in tablet coatings and sustained-release formulations to control how quickly the medicine dissolves and releases.
  • UNII 7G1J5DA97F
    White wax is a refined, bleached plant-based or mineral wax that serves as a coating and hardening agent in medicines. It helps control how fast the drug dissolves and improves the product's texture and appearance.

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

The official label also statesInactive ingredients Beeswax, ButyrospermumParkii (Shea) Butter, Prunus Amygdalus Dulcis (SweetAlmond) Oil, Dimethicone, Hydrogenated Poly (C6-14Olefin), Trimethylpentanediol /Adipic Acid/GlycerinCrosspolymer, Polysilicone-11, Menthyl Nicotinate,Ethylene/Propylene/Styrene Copolymer, Flavor, PunicaGranatum (Pomegranate) Seed Oil, Sodium Saccharin,Butylene/Ethylene/Styrene Copolymer, PentaerythritylTetra-di-t-butyl Hydroxyhydrocinnamate

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 eachPer 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Petrolatum 30 g/100g 33992-0498-01 Greenbrier 85 g — — FDA listed —
Petrolatum 30 g/100g 33992-0499-01 Greenbrier 85 g — — FDA listed —
Personal Care Creamy Cocoa Butter Petroleum 30 g/100g 76176-0023-01 Ningbo 128 g — — FDA listed —
Aquaphor Healing Balm Stick 30 g/100g 10356-0125-55 Beiersdorf 18.4 g — — FDA listed —
Creamy Petroleum 30 g/100g 83650-0103-01 Savvy 133 g — — FDA listed —
Royal Creamy Petroelum 30 g/100g 85891-0011-01 SPARROW 24 tubes — — Discontinued —
Baby Balm Stick 0.65oz 30 g/100g 57337-0167-01 Rejoice 18.4 g — — FDA listed —
CareALL Creamy Petroleum Jelly 30 g/100g 51824-0082-03 New 85 g — — FDA listed —
Personal Care Creamy Petroleum 30 g/100g 76176-0022-01 Ningbo 128 g — — FDA listed —
CareALL Creamy Cocoa Butter Petroleum Jelly 30 g/100g 51824-0083-03 New 85 g — — FDA listed —
Advanced Healing Balm 30 g/100g 57337-0192-01 Rejoice 18.4 g — — FDA listed —
Royal Creamy Petroelum Intensive Care Cocoa Scent 30 g/100g 85891-0013-01 SPARROW 24 tubes — — Discontinued —
Walgreens Baby Healing Balm 30 g/100g 00363-2823-01 Walgreens 50 g — — FDA listed —
OKeeffes Lip Repair SEAL and HEAL 30 g/100gthis 71564-0011-22 The 2 cylinders — — 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

🏛️
2026
On the market since
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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
71564-0011-22 You're viewing this 2 CYLINDER in 1 BLISTER PACK (71564-011-22) / 4.2 g in 1 CYLINDER 2026-07-22 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) ✓ 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 71564-011-22, 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: 71564-0011-22, written without dashes as 71564001122. 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 71564-0011-22, the first segment (71564) is the labeler code FDA assigned to The Gorilla Glue Company/O'Keeffe's Company; the middle segment (0011) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (22) 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 The Gorilla Glue Company/O'Keeffe's Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
The Gorilla Glue Company/O'Keeffe's Company 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 23 words ▾

Uses helps prevent and temporarily protects chapped or cracked lips helps prevent and protect from the drying effects of wind and cold weather

⏱️ Dosage and Administration 4 words ▾

Directions apply as needed

⚠️ Warnings 59 words ▾

Warnings For external use only When using this product • do not get into eyes Stop use and ask a doctor if condition worsens symptoms 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.

🧪 Active Ingredient 4 words ▾

Active ingredients Petrolatum 30%

🧪 Inactive Ingredients 32 words ▾

Inactive ingredients Beeswax, ButyrospermumParkii (Shea) Butter, Prunus Amygdalus Dulcis (SweetAlmond) Oil, Dimethicone, Hydrogenated Poly (C6-14Olefin), Trimethylpentanediol /Adipic Acid/GlycerinCrosspolymer, Polysilicone-11, Menthyl Nicotinate,Ethylene/Propylene/Styrene Copolymer, Flavor, PunicaGranatum (Pomegranate) Seed Oil, Sodium Saccharin,Butylene/Ethylene/Styrene Copolymer, PentaerythritylTetra-di-t-butyl Hydroxyhydrocinnamate

🎯 Purpose 3 words ▾

Purpose Lip Protectant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71564-0010-98 · The 71566-0100-08 · Pediatric →
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.