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Nuby Soothing Gel 12 [hp_X]/15g; 12 [hp_X]/15g; 30 [hp_X]/15g Gel — NDC 85182-0240-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nuby Soothing Gel 12 [hp_X]/15g; 12 [hp_X]/15g; 30 [hp_X]/15g Gel — NDC 85182-240-04 (Billing 85182-0240-04)

by NINGBO RAFFINI IMPORTS & EXPORTS CO LTD · 1 TUBE in 1 BLISTER PACK / 15 g in 1 TUBE

This is a package of Nuby Soothing Gel 12 [hp_X]/15g; 12 [hp_X]/15g; 30 [hp_X]/15g Gel from NINGBO RAFFINI IMPORTS & EXPORTS CO LTD, marketed since Jan 2025 and currently FDA-listed. It is this product's only package size.

NDC 85182-0240-04
🏷️ FDA NDC (as labeled) 85182-240-04 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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) 85182-240-04
Product NDC 85182-240
11-digit billing NDC 85182024004
UNII 91D9GV0Z28, G0R4UBI2ZZ, MUE8Y11327
UPC 0370797240164
SPL Set ID 290692c0-54d9-d401-e063-6294a90a705a
Established class (EPC) Blood Coagulation Factor; Cations; Phosphate Binder
Mechanism of action Phosphate Chelating Activity
Physiologic effect Increased Coagulation Factor Activity
Chemical class Calcium; Divalent
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-01-21
Route TOPICAL
Dosage form GEL
Substance TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; ARNICA MONTANA ROOT
Why two NDCs? The FDA registers this code as 85182-240-04 — 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 → 85182-0240-04. 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?

Nuby Soothing Gel is a topical gel marketed as a homeopathic product containing arnica montana root, matricaria recutita (chamomile), and tribasic calcium phosphate. In homeopathic practice, these ingredients are traditionally used for comfort and soothing purposes. This product is not evaluated by the FDA for effectiveness and is marketed based on homeopathic tradition rather than established clinical evidence.

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
85182-0240-04 You're viewing this Main listing 1 TUBE in 1 BLISTER PACK / 15 g in 1 TUBE 2025-01-21 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nuby Soothing Gel 12 [hp_X]/15g; 12 [hp_X]/15g; 30 [hp_X]/15gthis 85182-0240-04 NINGBO 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
Jan 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 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 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe 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 TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesAqua (Purified Water) Potassium Sorbate NF Sodium Benzoate NF Sorbic Acid NF Vegetable Glycerin USP Xantham Gum NF

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

LabelerNINGBO RAFFINI IMPORTS & EXPORTS CO LTD
Labeler code85182
First marketedJan 2025
Product typeHuman Otc Drug
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.
⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📖 Instructions for Use 📄 Package Label / Principal Display Panel
⚠️ Warnings 28 words ▾

Counsult a Physician if symptoms persist for more than 72 hours or worsen irritation, pain, or redness persits or worsen rash or fever develops swelling increases 5- WARNINGS

🧪 Active Ingredient 19 words ▾

Arnica, radix 30X HPUS 3.33 % Calcarea phosphorica 12XHPUS 3.33 % Chamomilla 12X HPUS 3.33 % 1- ACTIVE INGREDIENTS

🧪 Inactive Ingredients 21 words ▾

Aqua (Purified Water) Potassium Sorbate NF Sodium Benzoate NF Sorbic Acid NF Vegetable Glycerin USP Xantham Gum NF 2- INACTIVE INGREDIENTS

🎯 Purpose 15 words ▾

Temporarily relieves sore gums, pain, and irritability due to oral discomfort. 3- Purpose and Uses

📄 Keep Out of Reach of Children 32 words ▾

Keep this and all medication out of the reach of children. In case of accidental overdose, contact a medical professional or a Poison Control immidiately. 7- KEEP OUT OF REACH OF CHILDREN

📄 Other Information 17 words ▾

Tamper evident - Do not use if tube tip is cut prior to opening 10- OTHER INFORMATION

📄 Questions or Comments 17 words ▾

Call us at 1-855-366-7755 (U.S.A. only) M-F 8 am - 5 pm CT 8- QUESTIONS OR COMMENTS

📖 Instructions for Use 50 words ▾

Wash hands before use Cut open tip of tube on score mark Use your fingertip or cotton applicator to gently apply a small pea-sized maount of Dr. Talbot's Soothing Gel to the affected area 15 miniutes as neccassary or as directed by a physician or health provider 6 - Directions

📄 Package Label / Principal Display Panel 17 words ▾

DR. Talbot's Soothing Gel Naturally Inspired Soothes sore Gums with Chamomile Benzocaine/Belladonna free 9- PRINCIPAL DISPLAY PANEL

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

About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Nuby Soothing Gel 12 [hp_X]/15g; 12 [hp_X]/15g; 30 [hp_X]/15g GEL is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.

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 "Unapproved Homeopathic". 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 NINGBO RAFFINI IMPORTS & EXPORTS CO LTD. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
NINGBO RAFFINI IMPORTS & EXPORTS CO LTD 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.
← 85179-0051-00 · I 85184-0001-01 · HAVER →
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.