![Formula 303 Valerian Root, Passiflora, Magnesium Carbonate 3 [hp_X]/1; 1 [hp_X]/1; 6 [hp_X]/1 Tablet, 45-count — NDC 52301-0303-45 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=50d35250-36d4-24bf-e054-00144ff8d46c&name=303panel.jpg)
Formula 303 Valerian Root, Passiflora, Magnesium Carbonate 3 [hp_X]/1; 1 [hp_X]/1; 6 [hp_X]/1 Tablet, 45-count
by Dee Cee Laboratories · 45 TABLET in 1 BOTTLE (52301-303-45)
NDC 52301-0303-45
🏷️ FDA NDC (as labeled)
52301-303-45
billing pads the product segment with a zero
This package
Contains45-count
Pack sizes7 compare ↓
Also comes in:
12 tablets 52301-0303-21
60 tablets 52301-0303-60
90 tablets 52301-0303-90
120 tablets 52301-0303-12
250 tablets 52301-0303-25
300 tablets 52301-0303-30
OTC
On market
Non-controlled
🗂️ Data synced Aug 27, 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)
52301-303-45
Product NDC
52301-303
11-digit billing NDC
52301030345
UNII
K8F3G29S6Z, 0E53J927NA, JWF5YAW3QW
SPL Set ID
50d35250-36d4-24bf-e054-00144ff8d46c
DEA schedule
Non-controlled
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
1990-09-19
Route
ORAL
Dosage form
TABLET
Substance
PASSIFLORA INCARNATA FLOWER; MAGNESIUM CARBONATE; VALERIAN
Why two NDCs?
The FDA registers this code as 52301-303-45 — 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 → 52301-0303-45. 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
LabelerDee Cee Laboratories
Labeler code52301
First marketedSep 1990
Product typeHuman Otc Drug
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 oral tablet marketed as a homeopathic product containing valerian root, passiflora (passionflower), and magnesium carbonate. In homeopathic practice, these plant and mineral ingredients are traditionally used to support relaxation and calm. Homeopathic products are marketed based on homeopathic theory and tradition rather than evaluated by the FDA for effectiveness. The specific potencies listed indicate this product follows homeopathic preparation methods.
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 Valerian Root, Passiflora, Magnesium Carbonate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
brown
ShapeRound
Imprint36
Size11 mm
ScoringNot scored
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 EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
-
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 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 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
-
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
5 inactive ingredients listed in the exact product block matched to this NDC.
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 |
|---|---|---|---|---|---|---|
| Formula 303 3 [hp_X]/1; 1 [hp_X]/1; 6 [hp_X]this 52301-0303-45 | Dee | 45 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
🏛️
1990
On the market since
Sep 1990
📍
2026
Currently FDA-listed
36 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 |
|---|---|---|---|
| 52301-0303-12 | 120 TABLET in 1 BOTTLE (52301-303-12) | 2017-06-23 | Active |
| 52301-0303-21 | 12 TABLET in 1 BAG (52301-303-21) | 2017-06-23 | Active |
| 52301-0303-25 | 250 TABLET in 1 BOTTLE (52301-303-25) | 1990-09-19 | Active |
| 52301-0303-30 | 300 TABLET in 1 BOTTLE (52301-303-30) | 2017-06-23 | Active |
| 52301-0303-45 You're viewing this | 45 TABLET in 1 BOTTLE (52301-303-45) | 1990-09-19 | Active |
| 52301-0303-60 | 60 TABLET in 1 BOTTLE (52301-303-60) | 2017-06-23 | Active |
| 52301-0303-90 | 90 TABLET in 1 BOTTLE (52301-303-90) | 1990-09-19 | Active |
You're viewing one of 7 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 52301-0303-45?
NDC 52301-0303-45 is a 45-count package — 45 tablet in 1 bottle.
What is the difference between NDC 52301-0303-45 and NDC 52301-0303-21?
Both are Formula 303 Valerian Root, Passiflora, Magnesium Carbonate 3 [hp_X]/1; 1 [hp_X]/1; 6 [hp_X]/1 Tablet — the drug itself is identical. NDC 52301-0303-45 is the 45-count package, while NDC 52301-0303-21 is the 12 tablets package.
What NDC number is used to bill for this package of Formula 303 Valerian Root, Passiflora, Magnesium Carbonate 3 [hp_X]/1; 1 [hp_X]/1; 6 [hp_X]/1 Tablet?
Bill NDC 52301-0303-45 — the 11-digit billing format is 52301030345. 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
Formula 303 Valerian Root, Passiflora, Magnesium Carbonate 3 [hp_X]/1; 1 [hp_X]/1; 6 [hp_X]/1 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 | ✓ 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 52301-303-45, 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: 52301-0303-45, written without dashes as 52301030345. 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 52301-0303-45, the first segment (52301) is the labeler code FDA assigned to Dee Cee Laboratories; the middle segment (0303) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (45) 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 Dee Cee Laboratories. 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 6 other package presentations of this same product, including 12 tablets (52301-0303-21), 60 tablets (52301-0303-60), 90 tablets (52301-0303-90). 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?
Dee Cee Laboratories 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 ▾
MUSCLE SPASM: As a muscle relaxant, two tablets every three hours until relief is obtained. Then two tablets with each meal and two and bedtime. TENSION AND STRESS: As a relaxant, two tablets with each meal and two at bedtime.
⏱️ Dosage and Administration ▾
Directions: Adults and children 12 years of age and older, take as directed or as directed by your doctor. Do not exceed 12 tablets in a 24 hour period. MUSCLE SPASM: As a muscle relaxant, two tablets every three hours until relief is obtained. Then two tablets with each meal and two at bedtime. TENSION AND STRESS: As a relaxant, two tablets with each meal and two at bedtime.
⚠️ Warnings ▾
WARNING: If you are pregnant or nursing a baby, seek the advice of a healthcare professional before using this product.
🧪 Active Ingredient ▾
Each Tablet Contains: 6 parts Valerian Root (Quad Strength) 1X, 3 parts Passiflora (Quad Strength) 1X, 1 part Magnesium Carbonate 1X.
🎯 Purpose ▾
Natural relief for muscle spasm, tension, and stress
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.