![Sleepology Alfalfa, Avena sativa, Chamomilla, Eschscholtzia californica, Gelsemium sempervirens, Nux moschata, Passiflora incarnata, Piper methysticum, Valeriana officinalis 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 9 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 12 [hp_X] Tablet, Chewable, 2-count — NDC 69676-0012-03 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1e11f655-374c-59ac-e054-00144ff8d46c&name=5A_Carton_R-20240624.jpg)
Sleepology Alfalfa, Avena sativa, Chamomilla, Eschscholtzia californica, Gelsemium sempervirens, Nux moschata, Passiflora incarnata, Piper methysticum, Valeriana officinalis 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 9 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 12 [hp_X] Tablet, Chewable, 2-count
by Genexa Inc. · 2 TABLET, CHEWABLE in 1 POUCH (69676-0012-3)
NDC 69676-0012-03
🏷️ FDA NDC (as labeled)
69676-0012-3
billing pads the package segment with a zero
This package
Contains2-count
Pack sizes2 compare ↓
Also comes in:
60 tablets 69676-0012-01
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)
69676-0012-3
Product NDC
69676-0012
11-digit billing NDC
69676001203
UNII
MA9CQJ3F7F, DJO934BRBD, 9315HN272X, CLF5YFS11O, AEE24M3MQ9, JWF5YAW3QW +3 more
UPC
0857630006090
SPL Set ID
1e11f655-374c-59ac-e054-00144ff8d46c
Established class (EPC)
Non-Standardized Food Allergenic Extract; Non-Standardized Plant Allergenic Extract
Physiologic effect
Increased Histamine Release; Cell-mediated Immunity
Chemical class
Allergens; Plant Proteins; Dietary Proteins; Food Additives; Seed Storage Proteins
DEA schedule
Non-controlled
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2016-03-21
Route
ORAL
Dosage form
TABLET, CHEWABLE
Substance
AVENA SATIVA FLOWERING TOP; ALFALFA; ESCHSCHOLZIA CALIFORNICA; PASSIFLORA INCARNATA FLOWERING TOP; NUTMEG; VALERIAN; PIPER METHYSTICUM ROOT; GELSEMIUM SEMPERVIRENS ROOT; MATRICARIA CHAMOMILLA WHOLE
Why two NDCs?
The FDA registers this code as 69676-0012-3 — 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 → 69676-0012-03. 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
LabelerGenexa Inc.
Labeler code69676
First marketedMar 2016
Product typeHuman Otc Drug
Portfolio40 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?
Sleepology is an unapproved homeopathic chewable tablet containing nine plant-derived ingredients. In homeopathic practice, these ingredients are traditionally used to promote relaxation and support sleep. The formulation includes valerian, passionflower, chamomile, California poppy, and nutmeg, which are commonly found in herbal preparations aimed at calming. Homeopathic products are marketed based on homeopathic tradition and have not been evaluated by the FDA 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 Alfalfa, Avena sativa, Chamomilla, Eschscholtzia californica, Gelsemium sempervirens, Nux moschata, Passiflora incarnata, Piper methysticum, Valeriana officinalis?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
white
ShapeRound
ImprintG
Size1 mm
ScoringNot scored
FlavorVanilla
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 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 R12CBM0EIZ
A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
-
UNII IY9XDZ35W2
Dextrose is a simple sugar derived from corn or other sources. It serves as a filler and sweetener in medicines to add bulk, improve taste, and help stabilize the medication's form.
-
UNII 7CVR7L4A2D
A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
-
UNII R60QEP13IC
Rice bran is a natural powder made from the outer layer of rice grains. It's used in medicines as a filler and flow agent to add bulk and help the product mix and flow smoothly during manufacturing.
4 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesInactive ingredients organic carnuaba wax, organic dextrose, organic maltodextrin, organic rice bran extract, natural vanilla lavender flavor
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.
Try another pack size:
60 tablets
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 |
|---|---|---|---|---|---|---|
| Sleepology 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 9 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 12 [hp_X]this 69676-0012-03 | Genexa | 2 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
🏛️
2016
On the market since
Mar 2016
📍
2026
Currently FDA-listed
10 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 |
|---|---|---|---|
| 69676-0012-01 | 1 BOTTLE, PLASTIC in 1 CARTON (69676-0012-1) / 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC | 2016-03-21 | Active |
| 69676-0012-03 You're viewing this | 2 TABLET, CHEWABLE in 1 POUCH (69676-0012-3) | 2017-10-30 | Active |
Pack size FAQ
What quantity is in NDC 69676-0012-03?
NDC 69676-0012-03 is a 2-count package — 2 tablet, chewable in 1 pouch.
What is the difference between NDC 69676-0012-03 and NDC 69676-0012-01?
Both are Sleepology Alfalfa, Avena sativa, Chamomilla, Eschscholtzia californica, Gelsemium sempervirens, Nux moschata, Passiflora incarnata, Piper methysticum, Valeriana officinalis 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 9 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 12 [hp_X] Tablet, Chewable — the drug itself is identical. NDC 69676-0012-03 is the 2-count package, while NDC 69676-0012-01 is the 60 tablets package.
What NDC number is used to bill for this package of Sleepology Alfalfa, Avena sativa, Chamomilla, Eschscholtzia californica, Gelsemium sempervirens, Nux moschata, Passiflora incarnata, Piper methysticum, Valeriana officinalis 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 9 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 12 [hp_X] Tablet, Chewable?
Bill NDC 69676-0012-03 — the 11-digit billing format is 69676001203. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
Homeopathic listing
About homeopathic listings
Sleepology Alfalfa, Avena sativa, Chamomilla, Eschscholtzia californica, Gelsemium sempervirens, Nux moschata, Passiflora incarnata, Piper methysticum, Valeriana officinalis 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 9 [hp_X]/1; 6 [hp_X]/1; 6 [hp_X]/1; 12 [hp_X] TABLET, CHEWABLE 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 69676-0012-3, 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: 69676-0012-03, written without dashes as 69676001203. 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 69676-0012-03, the first segment (69676) is the labeler code FDA assigned to Genexa Inc.; the middle segment (0012) 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 Genexa Inc.. 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 60 tablets (69676-0012-01). 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?
Genexa 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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses* addresses sleeplessness and/or restless sleep.
⏱️ Dosage and Administration ▾
Directions take dose at bedtime chew tablets before swallowing; do not swallow whole adults and children 12 years of age and older 2 tablets children 3-11 years of age 1 tablet children under 3 years of age ask a doctor before use
⚠️ Warnings ▾
Warnings
📦 Storage and Handling ▾
Other information store between 20-25°C (68-77°F) in a dry place out of direct sunlight
🧪 Active Ingredient ▾
Active ingredients ‡ ** Alfalfa 6X HPUS Avena sativa 6X HPUS Chamomilla 6X HPUS Eschscholzia californica 6X HPUS Gelsemium sempervirens 12X HPUS Nux moschata 9X HPUS Passiflora incarnata 6X HPUS Piper methysticum 6X HPUS Valeriana officinalis 6X HPUS ‡ Organic "HPUS" indicates that this ingredient is officially included in the Homoeopathic Pharmacopoeia of the United States.
🧪 Inactive Ingredients ▾
Inactive ingredients organic carnuaba wax, organic dextrose, organic maltodextrin, organic rice bran extract, natural vanilla lavender flavor
🎯 Purpose ▾
Purpose* restless sleep sleeplessness from nervousness and exhaustion inability to fall asleep sleeplessness from stress sleeplessness from pain, irritability and excitability frequent waking sleeplessness from worries and restlessness inability to fall asleep restless sleep
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.