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Sleep gummies 1 g/1001; 2 g/1001 Chewable Gel, 60-count — NDC 83739-0004-01 package photo

Sleep gummies 1 g/1001; 2 g/1001 Chewable Gel, 60-count

by XIAN CHIANG COMPANY LIMITED · 60 CHEWABLE GEL in 1 BOTTLE (83739-004-01)
NDC 83739-0004-01
🏷️ FDA NDC (as labeled) 83739-004-01 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 83739-004-01
Product NDC 83739-004
11-digit billing NDC 83739000401
UNII R3NBG8914U, 0O72R8RF8A
SPL Set ID 07a88f30-6a66-40d5-e063-6394a90a19a3
Established class (EPC) Non-Standardized Food Allergenic Extract; Non-Standardized Plant Allergenic Extract; Amino Acid Hypertonic Solution
Physiologic effect Increased Histamine Release; Cell-mediated Immunity
Chemical class Allergens; Dietary Proteins; Plant Proteins; Amino Acids
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-10-14
Route ORAL
Dosage form CHEWABLE GEL
Substance BARLEY MALT; AMINO ACIDS
Why two NDCs? The FDA registers this code as 83739-004-01 — 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 → 83739-0004-01. 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

LabelerXIAN CHIANG COMPANY LIMITED
Labeler code83739
First marketedOct 2023
Product typeHuman Otc Drug
Portfolio9 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?

This is an unapproved chewable gel product taken by mouth that contains amino acids and barley malt extract as active ingredients. Amino acids are building blocks commonly included in dietary supplements and sleep products for various metabolic functions. Barley malt is a grain-derived ingredient that appears in nutritional and herbal supplement formulations. This product is marketed without FDA approval and should not be assumed to be proven safe or effective.

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.

🧪 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 2ACZ6IPC6I
    A naturally occurring compound in the body that acts as a neurotransmitter. In medicines, it may serve as a buffer or pH regulator to help stabilize the formulation and maintain proper acidity levels.
  • UNII 7V515PI7F6
    Apigenin is a plant-derived flavonoid compound. It's used in formulations as a natural colorant and antioxidant to help protect the medicine's stability and appearance.
  • UNII PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII C04977SRJ5
    Ceramide NG is a naturally occurring lipid compound that helps form protective barriers in skin and cosmetic formulations. It functions as an emollient and skin-conditioning agent, helping products retain moisture and maintain smooth texture.
  • UNII 789U1901C5
    Bronze powder is a metallic mixture of copper and tin. It's used as a colorant in some medications to create a distinctive appearance and help identify the product.
  • UNII S270N0TRQY
    Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
  • UNII IFN18A4Y6B
    Magnesium glycinate is magnesium combined with the amino acid glycine. In medicines, it serves as a source of magnesium and may improve absorption compared to other magnesium forms.
  • UNII JL5DK93RCL
    Melatonin is a hormone naturally produced in the body that regulates sleep cycles. In medicines, it's included as an active ingredient to help promote sleep, not as an inactive filler or binder.
  • UNII 50D2ZE9219
    A plant extract from lemon balm leaves, used as a flavoring and aromatic ingredient to improve the taste and smell of the medicine.
  • UNII 15H40G5NSR
    Passiflora caerulea is a plant extract from passion fruit. It may be added to medicines as a flavoring agent or for its traditional use in botanical formulations.
  • UNII RKH8WR95Z0
    A synthetic compound made by attaching penicillin molecules to polylysine protein. It's used in allergy testing products to help detect penicillin sensitivity before medication use.
  • UNII KV2JZ1BI6Z
    Pyridoxine is a form of vitamin B6, a water-soluble vitamin. It's added to medicines as a nutritional supplement to help maintain adequate B6 levels in the body.
  • UNII TKD8LH0X2Z
    Reishi is a mushroom extract used in supplements and some medicines. It may function as a filler or active botanical ingredient, though its primary role in formulations is often to add volume or provide traditional plant-based content.
  • UNII 8021PR16QO
    Theanine is an amino acid found naturally in tea leaves. In medications, it's typically used as an active ingredient for its potential calming effects, though it may also function as a flavor component or dietary supplement ingredient in some formulations.
  • UNII JWF5YAW3QW
    A plant extract traditionally derived from the valerian root. It functions as a flavoring agent and may contribute mild aromatics to the formulation.
  • UNII SOI2LOH54Z
    Zinc oxide is a white mineral powder used in medicines as a protective barrier agent and color additive. It helps shield skin in topical products and may also serve as a filler or opacifying ingredient.

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

The official label also statesEgg Shell Collagen, Phytoceramides, Reishi Fruiting Body Extract,Magnesium Bisglycinate, L-Theanine, Liposomal Apigenin (from chamomile), GABA, Vitamin C, Liposomal Hyaluronic Acid, Valarian Root, Blue Passion Flower Extract, Lemon Balm Leaf Extract, Vitamin B6, Chelated Zinc Oxide, Copper, Melatonin.

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sleep gummies 1 g/1001; 2 g/1001this 83739-0004-01 XIAN 60 chewables — — 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

🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 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.

🔬 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 Sleep gummies — the ingredient across all brands.

Top reported reactions

Akathisia1
Amnesia1
Anxiety1
Burning Sensation1
Cognitive Disorder1
Constipation1
Decreased Appetite1

Reporter sex

3 reports
Male · 33%
Female · 67%

Serious outcomes

Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2025 2026 3 0
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
83739-0004-01 You're viewing this 60 CHEWABLE GEL in 1 BOTTLE (83739-004-01) 2023-10-14 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 Drug Other". 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 83739-004-01, 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: 83739-0004-01, written without dashes as 83739000401. 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 83739-0004-01, the first segment (83739) is the labeler code FDA assigned to XIAN CHIANG COMPANY LIMITED; the middle segment (0004) 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 XIAN CHIANG COMPANY LIMITED. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
XIAN CHIANG COMPANY LIMITED 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 3 words ▾

Uses Regulating immunity

⏱️ Dosage and Administration 30 words ▾

Instructions Once a day , 2 gummies each time , taken with warm water Seal and place in a cool and dry place This product cannot replace medication for treatment

⚠️ Warnings 5 words ▾

Warnings For internal use only

📦 Storage and Handling 13 words ▾

Other information Other information store at 20-30°C ( 68-77F ) protect from excessive

🧪 Active Ingredient 8 words ▾

Active Ingredient Amino acids 2%, BARLEY MALT 1%

🧪 Inactive Ingredients 54 words ▾

inactive ingredients Egg Shell Collagen , Phytoceramides , Reishi Fruiting Body Extract ,Magnesium Bisglycinate , L-Theanine , Liposomal Apigenin ( from chamomile ) , GABA , Vitamin C , Liposomal Hyaluronic Acid , Valarian Root, Blue Passion Flower Extract , Lemon Balm Leaf Extract , Vitamin B6, Chelated Zinc Oxide , Copper , Melatonin.

🎯 Purpose 8 words ▾

Purpose Promote sleep health Regulate the immune system

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 83739-0003-01 · XIAN 83739-0005-01 · XIAN →
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.