Melatonin Pro Calcarea Carbonica, Chamomilla, Cocculus Indicus, Coffea Cruda, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Carbonica, Melatonin, Natrum Muriaticum, Nux Vomica, Pulsatilla (Pratensis) 12 [hp_X]/1; 12 [hp_X]/1; 12 [hp_X]/1; 12 [hp_X]/1; 12 [hp_X]/1; 12 [hp_X]/1; 12 Tablet, 60-count
by Energique, Inc. · 60 TABLET in 1 BOTTLE, PLASTIC (44911-0500-1)
NDC 44911-0500-01
🏷️ FDA NDC (as labeled)
44911-0500-1
billing pads the package segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Sep 24, 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)
44911-0500-1
Product NDC
44911-0500
11-digit billing NDC
44911050001
UNII
2E32821G6I, G0R4UBI2ZZ, 810258W28U, 3SW678MX72, 91GQH8I5F7, CI71S98N1Z +5 more
SPL Set ID
1f374642-83f7-4e64-b330-0f6ef21000a9
Established class (EPC)
Non-Standardized Food Allergenic Extract; Non-Standardized Plant Allergenic Extract
Physiologic effect
Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production
Chemical class
Allergens; Dietary Proteins; Plant Proteins; Seed Storage Proteins
DEA schedule
Non-controlled
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2019-06-07
Route
ORAL
Dosage form
TABLET
Substance
OYSTER SHELL CALCIUM CARBONATE, CRUDE; MATRICARIA CHAMOMILLA; ANAMIRTA COCCULUS SEED; ARABICA COFFEE BEAN; FERROSOFERRIC PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE; MAGNESIUM CARBONATE; MELATONIN; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PULSATILLA PRATENS
Why two NDCs?
The FDA registers this code as 44911-0500-1 — a 5-4-1 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 package segment → 44911-0500-01. 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.
🏭 Manufacturer & labeler
LabelerEnergique, Inc.
Labeler code44911
First marketedJun 2019
Product typeHuman Otc Drug
Portfolio350 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?
Melatonin Pro is an unapproved homeopathic tablet taken by mouth. It contains melatonin, a hormone typically associated with sleep regulation, along with multiple plant and mineral substances used in homeopathic tradition. These additional ingredients, including chamomilla, coffea cruda, and nux vomica, are selected according to homeopathic principles rather than evaluated by the FDA for effectiveness. Homeopathic products are marketed based on traditional use, not established medical evidence.
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 Calcarea Carbonica, Chamomilla, Cocculus Indicus, Coffea Cruda, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Carbonica, Melatonin, Natrum Muriaticum, Nux Vomica, Pulsatilla (Pratensis)?
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 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
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UNII D9C330MD8B
Copovidone is a synthetic polymer made by combining two types of plastic-like molecules. It acts as a binder and film-former to help hold tablet ingredients together and improve how the medicine dissolves in your body.
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UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
-
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII SMD1X3XO9M
Powdered cellulose is a fine, plant-based powder made from purified wood fibers. In medicines, it acts as a filler to add bulk and volume, and helps tablets or capsules hold together during manufacturing and storage.
-
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
-
UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
9 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesCopovidone, Crospovidone, Lactose, Magnesium Stearate, Mannitol, Melatonin, Microcrystalline Cellulose, Silicone Dioxide, Sorbitol, Vegetable Capsule (Cellulose).
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 each | 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 |
|---|---|---|---|---|---|---|
| Melatonin Pro 12 [hp_X]/1; 12 [hp_X]/1; 12 [hp_X]/1; 12 [hp_X]/1; 12 [hp_X]/1; 12 [hp_X]/1; 12this 44911-0500-01 | Energique, | 60 tablets | — | — | 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
🏛️
2019
On the market since
Jun 2019
📍
2026
Currently FDA-listed
7 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 |
|---|---|---|---|
| 44911-0500-01 You're viewing this | 60 TABLET in 1 BOTTLE, PLASTIC (44911-0500-1) | 2019-06-07 | Active |
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
Homeopathic listing
About homeopathic listings
Melatonin Pro Calcarea Carbonica, Chamomilla, Cocculus Indicus, Coffea Cruda, Ferrum Phosphoricum, Kali Phosphoricum, Magnesia Carbonica, Melatonin, Natrum Muriaticum, Nux Vomica, Pulsatilla (Pratensis) 12 [hp_X]/1; 12 [hp_X]/1; 12 [hp_X]/1; 12 [hp_X]/1; 12 [hp_X]/1; 12 [hp_X]/1; 12 TABLET 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 | — Not published for this NDC No photo available yet for this listing. |
| 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 44911-0500-1, 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: 44911-0500-01, written without dashes as 44911050001. 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 44911-0500-01, the first segment (44911) is the labeler code FDA assigned to Energique, Inc.; the middle segment (0500) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Energique, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Energique, Inc. 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
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
INDICATIONS: May temporarily help to support healthy sleep and circadian rhythm.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
⏱️ Dosage and Administration ▾
DIRECTIONS: Adults take one capsule 30 minutes before bedtime or as directed by a health professional only.
⚠️ Warnings ▾
WARNINGS: Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing.
Store in a cool, dry place. Not to be taken by pregnant or lactating women. If you are taking MAO inhibitors, immunosuppressant drugs, anti-coagulation therapy, or anti-hypertensive medication, or have an autoimmune, seizure, psychiatric or depressive disorder consult your healthcare professional before using this product.
Long-term use of melatonin has not been studied. May cause drowsiness. Do not use before or while operating a motor vehicle or heavy machinery.
🧪 Active Ingredient ▾
ACTIVE INGREDIENTS: (in each capsule): 0.09% of Calcarea Carbonica 12X, Chamomilla 12X, Cocculus Indicus 12X, Coffea Cruda 12X, Ferrum Phosphoricum 12X, Kali Phosphoricum 12X, Magnesia Carbonica 12X, Melatonin 12X, Natrum Muriaticum 12X, Nux Vomica 12X, Pulsatilla (Pratensis) 12X.
🧪 Inactive Ingredients ▾
INACTIVE INGREDIENTS: Copovidone, Crospovidone, Lactose, Magnesium Stearate, Mannitol, Melatonin, Microcrystalline Cellulose, Silicone Dioxide, Sorbitol, Vegetable Capsule (Cellulose).
🎯 Purpose ▾
INDICATIONS: May temporarily help to support healthy sleep and circadian rhythm.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
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.