Home › NDC Lookup › Ingredients › Allantoin › 85384-0007-01
Tagrid Skin Repair Cream Allantoin 10 mg/g Cream, 30 g — NDC 85384-0007-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tagrid Skin Repair Cream Allantoin 10 mg/g Cream, 30 g — NDC 85384-0007-1 (Billing 85384-0007-01)

by TAGRID LLC · 30 g in 1 TUBE

This is a package of 30 g of Tagrid Skin Repair Cream Allantoin 10 mg/g Cream from TAGRID LLC, marketed since May 2025 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 85384-0007-01
🏷️ FDA NDC (as labeled) 85384-0007-1 billing pads the package segment with a zero
This package
Contains30 g Pack sizes3 compare ↓
Main listing for product 85384-0007 · Also comes in: 15 g 85384-0007-3 20 g 85384-0007-2
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) 85384-0007-1
Product NDC 85384-0007
11-digit billing NDC 85384000701
UNII 344S277G0Z
Application # M016
SPL Set ID 34a8bf10-1c18-1c14-e063-6394a90a0a6f
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-05-23
Route TOPICAL
Dosage form CREAM
Substance ALLANTOIN
Why two NDCs? The FDA registers this code as 85384-0007-1 — a 5-4-1 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 package segment → 85384-0007-01. 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?

Tagrid Skin Repair Cream is a topical cream containing allantoin, an over-the-counter monograph product. Allantoin is commonly used in skin care products for its role in moisturizing and supporting skin barrier function. This cream is applied directly to the skin and is intended for external use only.

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.
Try another pack size: 15 g 20 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
85384-0007-01 You're viewing this Main listing 30 g in 1 TUBE 2025-05-23 — Active
85384-0007-02 85384-0007-2 20 g in 1 TUBE 2025-05-23 — Active
85384-0007-03 85384-0007-3 15 g in 1 TUBE 2025-05-23 — Active

You're viewing the largest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 30 g — 30 g in 1 tube.
How does this package differ from NDC 85384-0007-03?
Both are Tagrid Skin Repair Cream Allantoin 10 mg/g Cream — the drug itself is identical. This page's package is the 30 g one, while NDC 85384-0007-03 is the 15 g package.
What NDC number is used to bill for this package of Tagrid Skin Repair Cream Allantoin 10 mg/g Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tagrid Skin Repair Cream 10 mg/gthis 85384-0007-01 TAGRID 30 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

🏛️
2025
On the market since
May 2025
📍
2026
Currently FDA-listed
1 year 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.

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 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.
  • 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 Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII N5CFT140R8
    A plant oil derived from cottonseed, used in medicines as a solvent or carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
  • UNII 3A3U0GI71G
    Magnesium oxide is a mineral compound that acts as a buffer and filler in medications. It helps neutralize stomach acid and adds bulk to the tablet or capsule formulation.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • UNII U27K0H1H2O
    Sage oil is a plant-derived liquid extracted from sage leaves. It's used in medicines as a flavoring agent and preservative to improve taste and help protect the product from spoilage.
  • UNII 4H6PCL92ZN
    Silver stearate is a metallic salt made from silver and stearic acid, a fatty substance. It works as a lubricant and glidant in tablet formulations, helping the medicine powder flow smoothly during manufacturing and preventing sticking.
  • UNII 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII 0T0DQN8786
    A plant extract from the leaves of the eastern arborvitae tree, used as a natural flavoring agent or preservative in some medicines.
  • UNII SOI2LOH54Z
    Zinc oxide is a white mineral powder used in medicines as a protective barrier agent and color additive. It helps shield skin in topical products and may also serve as a filler or opacifying ingredient.

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

The official label also statesBeeswax, Calendula officinalis Flower Extract, Cocos nucifera (Coconut) Oil, Gossypium herbaceum (Cotton) Seed Oil, Simmondsia chinensis (Jojoba) Seed Oil, Magnesium Oxide, Medium Chain Triglycerides, Mentha piperita (Peppermint) Oil, Salvia officinalis (Sage) Oil, Silver Stearate, Helianthus annuus (Sunflower) Seed Oil, Melaleuca alternifolia (Tea Tree) Leaf Oil, Thuja occidentalis Leaf Extract, Zinc Oxide.

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

LabelerTAGRID LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code85384
First marketedMay 2025
Product typeHuman Otc Drug
Portfolio24 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 18 words ▾

Temporarily protects minor cuts, scrapes, and burns. Helps relieve and promote healing of chapped, chafed, or cracked skin.

⏱️ Dosage and Administration 42 words ▾

Directions Clean the affected area before application. Apply a small amount of the ointment to the affected area 1 to 3 times daily, or as directed by a healthcare provider. May cover with a sterile bandage if desired. Wash hands after use.

⚠️ Warnings 123 words ▾

For external use only Do not use: In the eyes, nose, mouth, or on large areas of the body If you are allergic to mupirocin or any of the ingredients in this product Ask a doctor before use if you have: Deep or puncture wounds Animal bites Serious burns Large areas of damaged skin ■ Avoid contact with eyes. If contact occurs, rinse thoroughly with water. ■ Use only as directed. Do not use for longer than prescribed. ■ Do not bandage tightly unless directed by a doctor.

Stop use and ask a doctor if Condition worsens or does not improve within 3-5 days Rash,irritation, or other allergic reaction develops If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 3 words ▾

Allantoin 1% (w/w/)

🧪 Inactive Ingredients 51 words ▾

Beeswax, Calendula officinalis Flower Extract, Cocos nucifera (Coconut) Oil, Gossypium herbaceum (Cotton) Seed Oil, Simmondsia chinensis (Jojoba) Seed Oil, Magnesium Oxide, Medium Chain Triglycerides, Mentha piperita (Peppermint) Oil, Salvia officinalis (Sage) Oil, Silver Stearate, Helianthus annuus (Sunflower) Seed Oil, Melaleuca alternifolia (Tea Tree) Leaf Oil, Thuja occidentalis Leaf Extract, Zinc Oxide.

🎯 Purpose 2 words ▾

Skin protectant

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

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 Allantoin — the ingredient across all brands.

Top reported reactions

Nausea410
Vomiting289
Condition Aggravated238
Dyspnoea217
Abdominal Pain207
Somnolence196
Fatigue179

Reporter sex

3,285 reports
Male · 46%
Female · 53%
Unknown · 0%

Serious outcomes

Death452
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.

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 TAGRID LLC. 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 2 other package presentations of this same product, including 15 g (85384-0007-03), 20 g (85384-0007-02). 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?
TAGRID LLC 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.