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Allantoin Medicinal Massage Oil 1 g/108.48g Oil, 108.48 g — NDC 82876-0438-34 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Allantoin Medicinal Massage Oil 1 g/108.48g Oil, 108.48 g — NDC 82876-438-34 (Billing 82876-0438-34)

by Carolina Cannabis Creations L.L.C · 108.48 g in 1 BOTTLE

This is a package of 108.48 g of Allantoin Medicinal Massage Oil 1 g/108.48g Oil from Carolina Cannabis Creations L.L.C, marketed since Sep 2022 and currently FDA-listed. It is this product's only package size.

NDC 82876-0438-34
🏷️ FDA NDC (as labeled) 82876-438-34 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 82876-438-34 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
82876 labeler · 438 product · 34 package
Package marketed since
Sep 6, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0850024328181
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 82876-438-34
Product NDC 82876-438
11-digit billing NDC 82876043834
UNII 344S277G0Z
UPC 0850024328181
Application # M016
SPL Set ID 04b5619b-2122-f159-e063-6394a90a2e05
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-09-06
Route TOPICAL
Dosage form OIL
Substance ALLANTOIN
Why two NDCs? The FDA registers this code as 82876-438-34 — 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 → 82876-0438-34. 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 oil that is marketed under FDA's monograph guidelines for skin care products. The active ingredient is allantoin, a compound typically used in topical products to help soothe and soften the skin. This oil form is applied directly to the skin and is commonly found in massage oils and moisturizing preparations intended for general skin care.

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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
82876-0438-34 You're viewing this Main listing 108.48 g in 1 BOTTLE 2023-09-06 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Allantoin 1 g/108.48gthis 82876-0438-34 Carolina 108.48 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

🏛️
2022
On the market since
Sep 2022
📍
2026
Currently FDA-listed
4 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.

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.

  • 27.2 g / 108.48 g 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.
  • 2.85 g / 108.48 g UNII U7L2JP51PR
    Arnica montana flower water is an extract made from arnica flowers. It's used in formulations as a fragrance, preservative, or skin-conditioning agent to add scent and help maintain product stability.
  • 1.13 g / 108.48 g UNII 19GBJ60SN5
    A naturally derived compound from cannabis plants used as an active pharmaceutical ingredient in certain FDA-approved medications. It is included to deliver the therapeutic substance rather than serve a traditional formulation role like binding or flavoring.
  • 10.58 g / 108.48 g 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.
  • 0.28 g / 108.48 g UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • 0.15 g / 108.48 g 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.
  • 65.29 g / 108.48 g UNII LZO6K1506A
    Rice bran oil is a natural oil extracted from rice grain. It's used in medicines as an emollient and solvent to help dissolve or suspend active ingredients and improve how the medicine feels when applied or taken.

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

The official label also statesArnica montana, Cannabidiol, Jojoba oil, Lavender oil, Peppermint oil, Rice bran oil, Sweet almond 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

LabelerCarolina Cannabis Creations L.L.C
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code82876
First marketedSep 2022
Product typeHuman Otc Drug
Portfolio2 products on file

More NDCs from Carolina Cannabis Creations L.L.C labeler code 82876

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 🆘 Overdosage 🧪 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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 26 words ▾

Uses Helps prevent and temporarily protect and help relieve chafed, chapped, or cracked skin. Helps prevent and protect from the drying of wind and cold weather

⏱️ Dosage and Administration 34 words ▾

Directions shake well before use. adults and children 2 years and over; apply as needed. children under 2 years; consult a doctor keep out of reach of children Keep out of reach of children

⚠️ Warnings 5 words ▾

Warnings For external use only.

🆘 Overdosage 15 words ▾

in case of overdose seek medical help or contact a poison control center right away

🧪 Active Ingredient 6 words ▾

Active ingredients Allantoin......1% Purpose Skin protectant

🧪 Inactive Ingredients 17 words ▾

inactive ingredients Arnica montana, Cannabidiol, Jojoba oil, Lavender oil, Peppermint oil, Rice bran oil, Sweet almond oil.

🎯 Purpose 3 words ▾

Purpose Skin protectant

📄 Do Not Use 12 words ▾

Do not use on deep or puncture wounds, animal bites, serious burns

📄 Ask a Doctor Before Use If 29 words ▾

Stop use and ask doctor if condition worsens, symptoms last for more than 7 days, condition clears up but occurs again within a few days, rash or irritation occurs

📄 When Using This Product 67 words ▾

When using this product Do not get into eyes Stop use and ask doctor if condition worsens, symptoms last for more than 7 days, condition clears up but occurs again within a few days, rash or irritation occurs Stop use and ask doctor if Condition worsens, Symptoms last for more than 7 days, condition clears up but occurs again in a few days, rash or irritation occurs

📄 Stop Use and Ask a Doctor If 29 words ▾

Stop use and ask doctor if Condition worsens, Symptoms last for more than 7 days, condition clears up but occurs again in a few days, rash or irritation occurs

🤰 If Pregnant or Breast-Feeding 26 words ▾

If pregnant or breast feeding Consult a health professional before use. in case of overdose seek medical help or contact a poison control center right away

📄 Keep Out of Reach of Children 12 words ▾

keep out of reach of children Keep out of reach of children

📄 Other Information 13 words ▾

Other information Store at 68-77 degrees F (20-25 degrees C), avoid direct sunlight

📄 Package Label / Principal Display Panel 2 words ▾

bottle label

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 (this brand).

Top reported reactions

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

Age at onset

Adult5
Elderly45

Reporter sex

212 reports
Male · 92%
Female · 8%

Serious outcomes

Death179
Disabling164
Hospitalization153
Life-threatening121
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 61 1
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 Carolina Cannabis Creations L.L.C. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Carolina Cannabis Creations L.L.C 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.
← 82876-0418-34 · Carolina 82876-0501-02 · Carolina →
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.