![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](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=71c2a2f7-4823-51cb-e053-2995a90a5fb8&name=NeoRelief_ForMenstrualPainCramps.5oz.jpg)
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
by BioLyte Laboratories, LLC · 1 BOTTLE, PUMP in 1 CARTON (58368-003-03) / 14.17 g in 1 BOTTLE, PUMP
NDC 58368-0003-03
🏷️ FDA NDC (as labeled)
58368-003-03
billing pads the product segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
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.
🏭 Manufacturer & labeler
LabelerBioLyte Laboratories, LLC
Labeler code58368
First marketedApr 2018
Product typeHuman Otc Drug
Portfolio4 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.
🩺 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.
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.
💬 Questions about Homeopathic pain relief gel?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
💲 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.
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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 58368-0003-03 You're viewing this | 1 BOTTLE, PUMP in 1 CARTON (58368-003-03) / 14.17 g in 1 BOTTLE, PUMP | 2018-04-27 | Active |
🧭 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 FDA registers it as 58368-003-03, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 58368-0003-03, written without dashes as 58368000303. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 58368-0003-03, the first segment (58368) is the labeler code FDA assigned to BioLyte Laboratories, LLC; the middle segment (0003) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
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.
📄 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
🎯 Indications and Usage ▾
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 ▾
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 ▾
Warnings For external use only Do not use on damged or broken skin. Keep out of eyes, open wounds, mucous membranes
📦 Storage and Handling ▾
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 ▾
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 ▾
Inactive Ingredients Citric Acid, Fulvic Acid, Glycerin, Potassium Sorbate, Purified Water, Sodium Hydroxide, Ultrez-10 Polymer.
🎯 Purpose ▾
Purpose Topical Analgesics Relief of Cramping Anti-inflammatory
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 ↗
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.