NDC 54973-3274-01 — CALMS FORTE avena sativa flowering top

🆔 Identity & classification

FDA NDC (as labeled) 54973-3274-1

Product NDC 54973-3274

11-digit billing NDC 54973327401

UNII MA9CQJ3F7F, 91D9GV0Z28, G0R4UBI2ZZ, 91GQH8I5F7, 01G73H6H83, CI71S98N1Z +3 more

SPL Set ID f48a35d4-aa0c-48b1-a2ad-a614ea2894e8

Established class (EPC) Non-Standardized Food Allergenic Extract; Non-Standardized Plant Allergenic Extract

Physiologic effect Increased Histamine Release; Cell-mediated Immunity

Chemical class Allergens; Dietary Proteins; Plant Proteins; Food Additives

DEA schedule Non-controlled

Marketing category UNAPPROVED HOMEOPATHIC

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2016-04-29

Route ORAL

Dosage form TABLET

Substance AVENA SATIVA FLOWERING TOP; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; FERROSOFERRIC PHOSPHATE; HOPS; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; PASSIFLORA INCARNATA FLOWER

Why two NDCs? The FDA registers this code as 54973-3274-1 — 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 → 54973-3274-01. 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

LabelerHyland's Inc.

Labeler code54973

First marketedApr 2016

Product typeHuman Otc Drug

Portfolio69 products on file

🔎 All NDCs from Hyland's Inc.

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?

Calms Forte is an unapproved homeopathic oral tablet containing plant extracts and mineral salts. The botanical ingredients, including oat flowering tops, chamomile, hops, and passionflower, are traditionally used in homeopathic practice for relaxation and calm. The product also contains various phosphate salts and an iron compound. Homeopathic products are marketed based on traditional homeopathic principles and have not been evaluated by the FDA for effectiveness.

Patient education

📘 MedlinePlus patient leaflet ↗

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.

💊 What it looks like

Color white

ShapeOval

ImprintHYL;CF

Size14 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 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 J2B2A4N98G
Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
UNII R4OXA9G5BV
A fatty acid salt derived from palm and stearic oils. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking together.
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
UNII 24SC3U704I
A powdery carbohydrate extracted from tapioca plant roots. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your digestive system.

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

The official label also statesLactose, Magnesium Stearate, Microcrystalline Cellulose, Starch (Corn and Tapioca).

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
Calms Forte 4 [hp_X]/1; 3 [hp_X]/1; 4 [hp_X]/1; 3 [hp_X]/1; 4 [hp_X]/1; 3 [hp_X]/1; 3 [hp_X]this 54973-3274-01	Hyland's	32 tablets	—	—	FDA listed	—
Calms Forte 4 [hp_X]/1; 3 [hp_X]/1; 4 [hp_X]/1; 3 [hp_X]/1; 4 [hp_X]/1; 3 [hp_X]/1; 3 [hp_X] 54973-3257-01	Hyland's	50 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

Apr 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
54973-3274-01 You're viewing this	1 BOTTLE, PLASTIC in 1 CARTON (54973-3274-1) / 32 TABLET in 1 BOTTLE, PLASTIC	2016-04-29	Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

CALMS FORTE avena sativa flowering top, tribasic calcium phosphate, matricaria recutita, ferrosoferric phosphate, hops, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, sodium phosphate, dibasic, heptahydrate, and passiflora incarnata flower 4 [hp_X]/1; 3 [hp_X]/1; 4 [hp_X]/1; 3 [hp_X]/1; 4 [hp_X]/1; 3 [hp_X]/1; 3 [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 54973-3274-1, 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: 54973-3274-01, written without dashes as 54973327401. 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 54973-3274-01, the first segment (54973) is the labeler code FDA assigned to Hyland's Inc.; the middle segment (3274) 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 Hyland's Inc.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Hyland's 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 17 words ▾

Uses Temporarily relieves the symptoms of occasional sleeplessness and restlessness with accompanying stress, anxiousness, nervousness and irritability.

⏱️ Dosage and Administration 59 words ▾

Directions Adults & children 12 years and over: As a relaxant: swallow 1-2 caplets with water as needed three times daily. For occasional sleeplessness: 1-3 caplets 1/2 to 1 hour before retiring. Children 6-12 years: As a relaxant: swallow 1 caplet with water as needed three times daily. For occasional sleeplessness: 1-2 caplets 1/2 to 1 hour before retiring.

⚠️ Warnings 96 words ▾

Warnings As with any drug, ask a doctor before use if pregnant or breast-feeding. Consult a physician if symptoms persist for more than 7 days. Keep this and all medications out of the reach of children.

In case of accidental overdose, contact a medical professional or Poison Control Center immediately. Do not use if imprinted tamper band is broken or missing. In case of emergency, contact a medical professional or Poison Control Center immediately.

Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

🧪 Active Ingredient 68 words ▾

Active ingredients Purpose "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States. Avena Sativa 4X HPUS stress, nervousness Calcarea Phosphorica 3X HPUS restlessness Chamomilla 4X HPUS nervous irritability Ferrum Phosphoricum 3X HPUS nervousness Humulus Lupulus 4X HPUS occasional sleeplessness Kali Phosphoricum 3X HPUS irritability Magnesia Phosphorica 3X HPUS mental anxiousness Natrum Phosphoricum 3X HPUS anxiousness Passiflora 4X HPUS restless sleep from exhaustion

🧪 Inactive Ingredients 11 words ▾

Inactive ingredients Lactose, Magnesium Stearate, Microcrystalline Cellulose, Starch (Corn and Tapioca).

🎯 Purpose 68 words ▾

Active ingredients Purpose "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States. Avena Sativa 4X HPUS stress, nervousness Calcarea Phosphorica 3X HPUS restlessness Chamomilla 4X HPUS nervous irritability Ferrum Phosphoricum 3X HPUS nervousness Humulus Lupulus 4X HPUS occasional sleeplessness Kali Phosphoricum 3X HPUS irritability Magnesia Phosphorica 3X HPUS mental anxiousness Natrum Phosphoricum 3X HPUS anxiousness Passiflora 4X HPUS restless sleep from exhaustion

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Avena Sativa Flowering Top, Tribasic Calcium Phosphate, Matricaria Recutita, Ferrosoferric Phosphate, Hops, Potassium Phosphate, Dibasic, Magnesium Phosphate, Dibasic Trihydrate, Sodium Phosphate, Dibasic, Heptahydrate, And Passiflora Incarnata Flower NDCsSame ingredient 🏭 All Hyland's labeler NDCsLabeler code 54973 📚 All Calculi Dissolution Agent NDCsDrug class