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Bed Sore and Wound Healing Cream Allantoin 5 mg/g Cream, 30 g — NDC 85384-0011-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Bed Sore and Wound Healing Cream Allantoin 5 mg/g Cream, 30 g — NDC 85384-0011-1 (Billing 85384-0011-01)

by TAGRID LLC · 30 g in 1 TUBE

This is a package of 30 g of Bed Sore and Wound Healing Cream Allantoin 5 mg/g Cream from TAGRID LLC, marketed since Jun 2025 and currently FDA-listed. It is this product's only package size.

NDC 85384-0011-01
🏷️ FDA NDC (as labeled) 85384-0011-1 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85384-0011-1
Product NDC 85384-0011
11-digit billing NDC 85384001101
Application # M016
SPL Set ID 389e27c8-f16a-4028-92b4-813a26114d15
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-02
Route TOPICAL
Dosage form CREAM
Substance ALLANTOIN
Why two NDCs? The FDA registers this code as 85384-0011-1 — 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 → 85384-0011-01. 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 cream containing allantoin, marketed under FDA's OTC monograph rules for wound-care products. Allantoin is an ingredient commonly used in creams and ointments applied to the skin to help support the healing process in minor cuts, scrapes, and pressure sores. The product is applied directly to affected skin areas and is intended for external use only.

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.

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
85384-0011-01 You're viewing this Main listing 30 g in 1 TUBE 2025-06-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetaphil Baby Soothe and Protect Cream 5 mg/g 00299-4103-05 Galderma 170 g — — FDA listed —
Cetaphil Soothing Gel Cream 5 mg/g 00299-4105-00 Galderma 10 g — — FDA listed —
Teevodar .5 g/100g 69435-1301-01 PEER 1 tube — — FDA listed —
DeFlame 5 mg/mL 78863-1270-01 Noon 1 tube — — FDA listed —
Drs. pharmacy Scar Cream .5 g/100g 80489-0333-01 OL 1 tube — — FDA listed —
First honey Burn Salve 5 mg/mL 81995-0056-01 First 1 tube — — FDA listed —
Bed Sore and Wound Healing Cream 5 mg/gthis 85384-0011-01 TAGRID 30 g — — FDA listed —
Advanced Formula Scar Defense Cream .5 g/100g 87512-0002-01 Yantai 20 g — — FDA listed —
Advanced Silicone Scar .5 g/100g 87512-0006-01 Yantai 20 g — — FDA listed —
Manuka Honey Extra Strength 5 mg/g 81995-0050-01 First 1 tube — — FDA listed —
DGH Advanced Formula Scar Skin Protectant 5 mg/g 55910-0540-01 Dolgencorp 1 tube — — FDA listed —
Mederma Advanced Scar 5 mg/g 73302-0201-20 PMI 1 tube — — FDA listed —
Mederma Advanced Scar 5 mg/g 00113-4085-20 L. 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

🏛️
2025
On the market since
Jun 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 7M867G6T1U
    Centella asiatica is a plant extract used in medicines as a skin-conditioning or soothing ingredient. It helps maintain product stability and may support skin comfort in topical formulations.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 3M4G523W1G
    Silver is a metallic element used in some medications as an antimicrobial agent in topical formulations. It helps prevent bacterial growth on wound dressings and certain skin preparations.
  • 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 Y9H1V576FH
    Honey is a natural sweetener made by bees from flower nectar. In medicines, it adds sweetness to improve taste and may help soothe throat irritation in lozenges or syrups.
  • UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII CQ2F5O6YIY
    A natural compound extracted from Centella asiatica plant used as an active skin-conditioning ingredient. It functions as a humectant and skin protectant to improve moisture retention and support skin barrier function in topical formulations.
  • 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 CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling 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.
  • UNII B6E5W8RQJ4
    White petrolatum is a purified mineral oil product used as a lubricant and skin protectant in medications. It helps pills slide through manufacturing equipment and can soften or protect the skin when applied topically.

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

The official label also statesInactive ingredients: Colloidal Silver Water Tocopherol Madecassoside Centella Asiatica Whole Sodium Hyaluronate Honey Polysorbate 60 Cetearyl Alcohol Mineral Oil White Petrolatum Glycerin Lavandula Angustifolia (Lavender) 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.

Manufacturer & labeler

LabelerTAGRID LLC
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code85384
First marketedJun 2025
Product typeHuman Otc Drug
Portfolio26 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 33 words ▾

Uses: Temporarily protects minor cuts, scrapes, and burns Helps relieve skin irritation associated with bed sores, pressure ulcers, or cracked skin Aids in the healing of wounds by forming a protective moisture barrier

⏱️ Dosage and Administration 34 words ▾

Directions: Clean the affected area Apply a thin layer to the affected area 2 to 3 times daily or as directed by a physician May be covered with a sterile bandage or left uncovered

⚠️ Warnings 115 words ▾

For external use only Do not use: On deep or puncture wounds On animal bites On serious burns Ask a doctor before use if you have: A serious wound or condition that requires medical attention When using this product Avoid contact with eyes. If contact occurs, rinse thoroughly with water. 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 You are allergic to any of the ingredients in this product If pregnant or breast-feeding Ask a health professional before use Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 4 words ▾

Active ingredient: Allantoin 0.5%

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients: Colloidal Silver Water Tocopherol Madecassoside Centella Asiatica Whole Sodium Hyaluronate Honey Polysorbate 60 Cetearyl Alcohol Mineral Oil White Petrolatum Glycerin Lavandula Angustifolia (Lavender) Oil

🎯 Purpose 2 words ▾

Skin Protectant

📄 Do Not Use 14 words ▾

Do not use: On deep or puncture wounds On animal bites On serious burns

📄 Ask a Doctor Before Use If 17 words ▾

Ask a doctor before use if you have: A serious wound or condition that requires medical attention

📄 When Using This Product 15 words ▾

When using this product Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

📄 Stop Use and Ask a Doctor If 36 words ▾

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 You are allergic to any of the ingredients in this product

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding Ask a health professional before use

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Other Information 23 words ▾

Other information: Store at 15°–30°C (59°–86°F) Avoid freezing and direct sunlight Tamper-evident: Do not use if seal under cap is broken or missing

📄 Questions or Comments 7 words ▾

Questions or comments? Contact us at [email protected]

📄 Package Label / Principal Display Panel 5 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL BedSoreWoundHealingCream.jpg

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 Bed Sore and Wound Healing Cream (this brand).

Top reported reactions

Condition Aggravated139
General Physical Health Deterioration137
Hyponatraemia136
Sepsis136
Multiple Organ Dysfunction Syndrome135
Somnolence134
Stress134

Reporter sex

0 reports
Male · 92%
Female · 8%

Serious outcomes

Death179
Hospitalization153
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 61 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.

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.
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.
← 85384-0010-01 · TAGRID 85384-0012-01 · TAGRID →
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.