Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Serum X Lidocaine hydrochloride .5 g/100g Gel, 1 packet — NDC 82317-001-01 (Billing 82317-0001-01)
by AO Biologix, LLC · 1 PACKET in 1 PACKAGE / .5 g in 1 PACKET
This is a package of 1 packet of Serum X Lidocaine hydrochloride .5 g/100g Gel from AO Biologix, LLC, marketed since Apr 2022 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
NDC 82317-0001-01
🏷️ FDA NDC (as labeled)
82317-001-01
billing pads the product segment with a zero
This package
Contains1 packet
Pack sizes2 compare ↓
Main listing for product 82317-001 · Also comes in:
30 g 82317-001-30
🗂️ 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 →
⚠️
Other active recalls for Lidocaine Hydrochloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 16, 2026 — Presence of Particulate Matter: Hair was found in products (Fresenius Kabi USA, LLC) · FDA recall D-0726-2026
Class II · Jun 8, 2026 — Lack of Assurance of Sterility (Asclemed USA Inc.) · FDA recall D-0658-2026
Class II · Apr 2, 2026 — Lack of Assurance of Sterility (Huons Co., Ltd.) · FDA recall D-0529-2026
Class II · Apr 2, 2026 — Lack of Assurance of Sterility (Huons Co., Ltd.) · FDA recall D-0532-2026
Class II · Nov 30, 2021 — Superpotent Drug: Minimally superpotent (Teligent Pharma, Inc.) · FDA recall D-0296-2022
Class I · Nov 30, 2021 — Superpotent Drug (Teligent Pharma, Inc.) · FDA recall D-0295-2022
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
82317-001-01
Product NDC
82317-001
11-digit billing NDC
82317000101
RxCUI
1011849
UNII
V13007Z41A
Application #
M017
SPL Set ID
e07b6268-6400-6849-e053-2a95a90a8b3e
Established class (EPC)
Amide Local Anesthetic; Antiarrhythmic
Physiologic effect
Local Anesthesia
Chemical class
Amides
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2022-04-21
Route
TOPICAL
Dosage form
GEL
Substance
LIDOCAINE HYDROCHLORIDE
Quick answers
- RxCUI (RxNorm): 1011849
Why two NDCs?
The FDA registers this code as 82317-001-01 — 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 → 82317-0001-01. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Antiarrhythmic class.
Pharmacologic class
Antiarrhythmic, Amide Local Anesthetic
Drug family (ATC)
Antiarrhythmics, class Ib, Local anesthetics, Anesthetics for topical use
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
📗 Our plain-language guide HelloPharmacist
- Lidocaine numbs the area where it is used. Clinicians inject it for procedures. Skin products are used for pain, itching, minor burns, insect bites, hemorrhoid discomfort, and in s...
- Clean and dry the skin first, then apply as your product’s directions say. Wash your hands afterward. Don’t exceed the number of uses on the label. Ask a doctor before using a prod...
- No. Heat can increase how much lidocaine your body absorbs. Don’t bandage tightly either. Also avoid using other topical pain products at the same time.
- Can I use a heating pad with a lidocaine patch?
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about Lidocaine hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per g | Per 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:
30 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 82317-0001-01 You're viewing this Main listing | 1 PACKET in 1 PACKAGE / .5 g in 1 PACKET | 2022-07-01 | — | Active |
| 82317-0001-30 82317-001-30 | 1 BOTTLE in 1 CARTON / 30 g in 1 BOTTLE | 2022-04-21 | — | Active |
Pack size FAQ
What quantity is in this package?
This package contains 1 packet — 1 packet in 1 package / .5 g in 1 packet.
What NDC number is used to bill for this package of Serum X Lidocaine hydrochloride .5 g/100g Gel?
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Walgreens Cooling 5 mg/g 00363-0954-80 | WALGREEN | 226 g | — | — | FDA listed | — |
| Sunburn Relief 5 mg/g 11822-0776-03 | Rite | 226 g | — | — | FDA listed | — |
| Sunburn Relief Gel 5 mg/g 30400-0605-01 | Jell | 170 g | — | — | FDA listed | — |
| TopCare Everyday After Sun Cooling 5 mg/g 36800-0953-80 | TOPCO | 226 g | — | — | FDA listed | — |
| 0.5% Lidocaine Burn Relief .5 g/100g 43473-0099-08 | Nantong | 3 bottles | — | — | FDA listed | — |
| Good Sense Burn Relief Aloe .5 g/100g 50804-0955-08 | Geiss, | 227 g | — | — | FDA listed | — |
| CVS Health Sunburn Relief Cooling Lidocaine 0.5 Pain-Relieving 5 mg/g 51316-0022-15 | CVS | 170 g | — | — | FDA listed | — |
| 0.5% Lidocaine Burn Relief .5 g/100g 52000-0437-08 | Universal | 3 bottles | — | — | FDA listed | — |
| MyDerm Aloe and Lidocaine .5 g/100mL 53329-0037-09 | Medline | 592 ml | — | — | FDA listed | — |
| Sunburn Relief 5 mg/g 55910-0177-34 | Old | 226 g | — | — | FDA listed | — |
| burnrelief 5 mg/g 56062-0942-34 | Publix | 226 g | — | — | FDA listed | — |
| QC Burn Relief Aloe .5 g/100g 63868-0095-08 | Chain | 227 g | — | — | FDA listed | — |
| Aloe Vera Gel 5 mg/g 63941-0005-34 | Valu | 226 g | — | — | FDA listed | — |
| Sunburn Relief Gel 5 mg/g 69842-0909-34 | CVS | 226 g | — | — | FDA listed | — |
| HealthWise Soothing Lidocaine Pain Relief .5 g/g 71101-0986-01 | Veridian | 1 bottle | — | — | FDA listed | — |
| Sunburn Relief Gel 5 mg/g 72288-0005-34 | Amazon.com | 226 g | — | — | FDA listed | — |
| MyDerm .5 g/100mL 72667-0008-01 | Inspec | 237 ml | — | — | FDA listed | — |
| MyDerm Aloe and Lidocaine .5 g/100mL 72667-0283-09 | Inspec | 592 ml | — | — | FDA listed | — |
| DCH Burn Relief .5 g/100g 72839-0955-08 | Derma | 227 g | — | — | FDA listed | — |
| equate Burn Relief .5 g/100g 79903-0237-08 | Walmart | 226 g | — | — | FDA listed | — |
| Caring mill Lidocaine Aloe Gel Burn and Pain Relief 5 mg/mL 81522-0953-01 | FSA | 237 ml | — | — | FDA listed | — |
| Serum X .5 g/100gthis 82317-0001-01 | AO | 1 packet | — | — | FDA listed | — |
| Pain Relieving Gel 5 mg/g 83324-0183-08 | Chain | 226 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2022
On the market since
Apr 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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.
- FDA Orange Book · refreshed Sep 3, 2026
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 T4V6TWG28D
A plant-derived thickening agent made from cellulose. It increases viscosity and helps form a gel or paste consistency in medications, and may serve as a binder or coating material in various formulations.
-
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
-
UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
-
UNII SE337SVY37
A mineral salt used as a buffer to help maintain the medicine's pH level and prevent breakdown of active ingredients. It also acts as a thickening agent in liquid formulations.
-
UNII 22ADO53M6F
A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
-
UNII W2T4YRA9AD
A protein enzyme derived from baker's yeast that breaks down harmful oxygen molecules. In medicines, it may act as an antioxidant to help protect the product's stability 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.
7 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesWater, Hydroxyethylcellulose, Disodium Phosphate, Sodium Phosphate, Methylparaben, Superoxide Dismutase, Propylparaben
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerAO Biologix, LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code82317
First marketedApr 2022
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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
📄 Do Not Use
📄 When Using This Product
📄 Stop Use and Ask a Doctor If
🤰 If Pregnant or Breast-Feeding
📄 Keep Out of Reach of Children
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses For the temporary relief of pain
⏱️ Dosage and Administration ▾
Directions Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily Children under 2 years of age: consult a doctor
⚠️ Warnings ▾
Warnings For external use only Do not use in large quantities, particularly over raw surfaces or blistered areas When using this product avoid contact with the eyes Stop use and ask doctor if condition worsens any allergic reaction occurs symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breastfeeding, ask a health professional before use. Keep out of the reacho f children. If swallowed, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information store in a cool, dry place away from light this package is child-resistant
🧪 Active Ingredient ▾
Active ingredient Lidocaine Hydrochloride 0.5%
🧪 Inactive Ingredients ▾
Inactive ingredients Water, Hydroxyethylcellulose, Disodium Phosphate, Sodium Phosphate, Methylparaben, Superoxide Dismutase, Propylparaben
🎯 Purpose ▾
Purpose Lidocaine Hydrochloride 0.5%...............Topical Analgesic
📄 Do Not Use ▾
Do not use in large quantities, particularly over raw surfaces or blistered areas
📄 When Using This Product ▾
When using this product avoid contact with the eyes
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask doctor if condition worsens any allergic reaction occurs symptoms persist for more than 7 days or clear up and occur again within a few days
🤰 If Pregnant or Breast-Feeding ▾
If pregnant or breastfeeding, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
Keep out of the reacho f children. If swallowed, get medical help or contact a Poison Control Center right away.
📄 Questions or Comments ▾
Questions or comments? Call 855-910-1252 Monday-Friday; 9am-5pm MST. SerumX.com
📄 Package Label / Principal Display Panel ▾
AO Biologix Serum X Pain Relief Gel Fast Acting Lidocaine With Antioxidant Properties 30mL/1 Fl. oz. 1 2
No label section mentions that — try another word, or open the full label on DailyMed below.
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 Serum X (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 35%
Female · 65%
Unknown · 1%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 AO Biologix, 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 1 other package presentation of this same product, including 1 bottle (82317-0001-30). 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?
AO Biologix, 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.