Home › NDC Lookup › Ingredients › Homeopathic Pain Relief Gel › 58368-0003-03
NeoRelief for Menstrual Pain and Cramps Homeopathic pain relief gel 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g Gel, 1 bottle — NDC 58368-0003-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

NeoRelief for Menstrual Pain and Cramps Homeopathic pain relief gel 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g Gel, 1 bottle — NDC 58368-003-03 (Billing 58368-0003-03)

by BioLyte Laboratories, LLC · 1 BOTTLE, PUMP in 1 CARTON / 14.17 g in 1 BOTTLE, PUMP

This is a package of 1 bottle of NeoRelief for Menstrual Pain and Cramps Homeopathic pain relief gel 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g Gel from BioLyte Laboratories, LLC, marketed since Apr 2018 and currently FDA-listed. It is this product's only package size.

NDC 58368-0003-03
🏷️ FDA NDC (as labeled) 58368-003-03 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 Oct 8, 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 58368-003-03 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
58368 labeler · 003 product · 03 package
Package marketed since
Apr 27, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5836800303 5
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58368-003-03
Product NDC 58368-003
11-digit billing NDC 58368000303
UNII BQN1B9B9HA, 1LZ13MQR0S, O80TY208ZW, WQZ3G9PF0H, T7J046YI2B, K73E24S6X9 +12 more
SPL Set ID 71c2a2f7-4823-51cb-e053-2995a90a5fb8
Established class (EPC) Standardized Insect Venom Allergenic Extract
Physiologic effect Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production
Chemical class Allergens; Bee Venoms
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-04-27
Route TOPICAL
Dosage form GEL
Substance POTASSIUM CARBONATE; FRANGULA CALIFORNICA BARK; ARNICA MONTANA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; BLACK COHOSH; CYCLAMEN PURPURASCENS TUBER; SARACA INDICA BARK; LILIUM LANCIFOLIUM WHOLE FLOWERING; JUNIPERUS SABINA LEAFY TWIG; BELLIS PERENNIS; SELENICE
Why two NDCs? The FDA registers this code as 58368-003-03 — 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 → 58368-0003-03. 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?

NeoRelief for Menstrual Pain and Cramps is a topical gel containing multiple plant and insect-derived ingredients used in homeopathic practice. The product includes substances such as arnica montana, belladonna, black cohosh, bryonia, and caulophyllum, which are traditionally used in homeopathic formulations for menstrual discomfort and related symptoms. This is an unapproved homeopathic product marketed based on homeopathic tradition rather than FDA evaluation for effectiveness.

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
58368-0003-03 You're viewing this Main listing 1 BOTTLE, PUMP in 1 CARTON / 14.17 g in 1 BOTTLE, PUMP 2018-04-27 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
NeoRelief for Menstrual Pain and Cramps 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/gthis 58368-0003-03 BioLyte 1 bottle — — 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

🏛️
2018
On the market since
Apr 2018
📍
2026
Currently FDA-listed
8 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.

  • UNII 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII XII14C5FXV
    Fulvic acid is an organic compound derived from decomposed plant material and soil. It is used in formulations as a humectant to help retain moisture and improve ingredient absorption and bioavailability.
  • 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective 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 statesCitric Acid, Fulvic Acid, Glycerin, Potassium Sorbate, Purified Water, Sodium Hydroxide, Ultrez-10 Polymer.

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

LabelerBioLyte Laboratories, LLC
Labeler code58368
First marketedApr 2018
Product typeHuman Otc Drug
Portfolio4 products on file

More NDCs from BioLyte Laboratories, LLC labeler code 58368

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor or Pharmacist Before Use If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 22 words ▾

Uses For temporary relief of menstrual symptoms such as: Menstrual pain, Cramping Indications are based on homeopathic materia medica, not clinical tests.

⏱️ Dosage and Administration 32 words ▾

Directions Women ages 8 years and older, spread thin layer on lower abdomen and lower back. Do not apply over other topical lotions; they may hinder effectiveness. Apply as needed for relief.

⚠️ Warnings 21 words ▾

Warnings For external use only Do not use on damged or broken skin. Keep out of eyes, open wounds, mucous membranes

📦 Storage and Handling 22 words ▾

Other Information Store in a cool, dry place. Avoid direct sunlight. Tamper-evident for your protection. Use only if safety seal is intact.

🧪 Active Ingredient 45 words ▾

Drug Facts Active Ingredients All actives are HPUS* and 4X potency. Apis, Arnica, Belladonna, Bryonia, Cimicifuga, Cyclamen, Joneosia, Kali Carb., Lilium, Rhamnus Calif., Sabina Bellis, Cactus, Caulophyllum, Colocynthis, Gelsemium, Viburnum Tilia *HPUS indicates the active ingredients are inthe official Homeopathic Pharmacopeia of the United States.

🧪 Inactive Ingredients 15 words ▾

Inactive Ingredients Citric Acid, Fulvic Acid, Glycerin, Potassium Sorbate, Purified Water, Sodium Hydroxide, Ultrez-10 Polymer.

🎯 Purpose 7 words ▾

Purpose Topical Analgesics Relief of Cramping Anti-inflammatory

📄 Ask a Doctor or Pharmacist Before Use If 13 words ▾

Warnings Stop use and ask doctor if: Condition worsens or persists, rash develops

🤰 If Pregnant or Breast-Feeding 10 words ▾

Warnings If pregnant or breastfeeding consult your doctor before use.

📄 Keep Out of Reach of Children 21 words ▾

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

📄 Questions or Comments 27 words ▾

Questions or Comments? 800.538.1455 Monday through Friday, 8 a.m. - 5 p.m. EST or visit us at neorelief.com. Reporty any serious side effects to the number above.

📄 Package Label / Principal Display Panel 29 words ▾

NEORELIEF for Menstrual Pain and Cramps NDC 58368-003-03 Patent Pending Neo Relief Temporary relief of Menstrual pain & cramps Homeopathic pain relief gel Net Wt. 0.5 oz (14.17g) NeoRelief_Menstural

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

NeoRelief for Menstrual Pain and Cramps Homeopathic pain relief gel 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g; 4 [hp_X]/g 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 BioLyte Laboratories, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
BioLyte Laboratories, 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.
← 58368-0002-02 · BioLyte 58368-0005-01 · BioLyte →
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.