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Leg Cramps PM oyster shell calcium carbonate, crude, causticum, matricaria recutita, cinchona officinalis bark, copper, lycopodium clavatum spore, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, silicon dioxide, and sulfur 12 [hp_X]/1; 12 [hp_X]/1; 6 [hp_X]/1; 3 [hp_X]/1; 12 [hp_X]/1; 12 [hp_X]/1; 6 [hp_X]/1 Tablet, Soluble, 16-count — NDC 54973-3093-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Leg Cramps PM oyster shell calcium carbonate, crude, causticum, matricaria recutita, cinchona officinalis bark, copper, lycopodium clavatum spore, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, silicon dioxide, and sulfur 12 [hp_X]/1; 12 [hp_X]/1; 6 [hp_X]/1; 3 [hp_X]/1; 12 [hp_X]/1; 12 [hp_X]/1; 6 [hp_X]/1 Tablet, Soluble, 16-count — NDC 54973-3093-8 (Billing 54973-3093-08)

by Hyland's Inc. · 1 BOTTLE, PLASTIC in 1 CARTON / 16 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC

This is a package of 16 tablets of Leg Cramps PM oyster shell calcium carbonate, crude, causticum, matricaria recutita, cinchona officinalis bark, copper, lycopodium clavatum spore, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, silicon dioxide, and sulfur 12 [hp_X]/1; 12 [hp_X]/1; 6 [hp_X]/1; 3 [hp_X]/1; 12 [hp_X]/1; 12 [hp_X]/1; 6 [hp_X]/1 Tablet, Soluble from Hyland's Inc., marketed since Jan 2010 and currently FDA-listed.

NDC 54973-3093-08
🏷️ FDA NDC (as labeled) 54973-3093-8 billing pads the package segment with a zero
This package
Contains16-count Pack sizes5 compare ↓
Product page 54973-3093-01 Also comes in: 4 tablets 54973-3093-6 16 tablets 54973-3093-7 30 tablets 54973-3093-2 50 tablets 54973-3093-1
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

NDC database record

One package, one record: these facts belong to NDC 54973-3093-8 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
54973 labeler · 3093 product · 8 package
Package marketed since
Jan 1, 2010
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5497330938 8
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 54973-3093-8
Product NDC 54973-3093
11-digit billing NDC 54973309308
UNII 2E32821G6I, DD5FO1WKFU, G0R4UBI2ZZ, S003A158SB, 789U1901C5, C88X29Y479 +4 more
SPL Set ID b0574a7e-88fa-417e-b6d5-60ced59eba47
Established class (EPC) Copper-containing Intrauterine Device
Physiologic effect Decreased Embryonic Implantation; Decreased Sperm Motility; Inhibit Ovum Fertilization
Chemical class Copper
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-01-01
Route ORAL
Dosage form TABLET, SOLUBLE
Substance OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAUSTICUM; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COPPER; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE; SULFUR
Why two NDCs? The FDA registers this code as 54973-3093-8 — 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 → 54973-3093-08. 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.

Clinical

🧪 What is this product?

Leg Cramps PM is an unapproved homeopathic oral tablet containing multiple plant, mineral, and elemental ingredients. In homeopathic practice, these substances are traditionally used to address symptoms such as muscle cramping, restlessness, and nighttime discomfort. Homeopathic products are marketed based on historical use and traditional claims rather than FDA evaluation for safety or effectiveness. The specific potencies and formulation are intended for oral dissolution.

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.

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 eachPer 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: 4 tablets 16 tablets 30 tablets 50 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
54973-3093-01 54973-3093-1 Main listing 50 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC 2010-01-01 — Active
54973-3093-02 54973-3093-2 1 BOTTLE in 1 CARTON / 30 TABLET, SOLUBLE in 1 BOTTLE 2010-01-01 — Active
54973-3093-06 54973-3093-6 4 TABLET, SOLUBLE in 1 POUCH Sample 2010-01-01 — Active
54973-3093-07 54973-3093-7 1 BOTTLE, PLASTIC in 1 CARTON / 16 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC 2010-01-01 — Active
54973-3093-08 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON / 16 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC 2010-01-01 — Active

Pack size FAQ

What quantity is in this package?
This is a 16-count package — 1 bottle, plastic in 1 carton / 16 tablet, soluble in 1 bottle, plastic.
How does this package differ from NDC 54973-3093-06?
Both are Leg Cramps PM oyster shell calcium carbonate, crude, causticum, matricaria recutita, cinchona officinalis bark, copper, lycopodium clavatum spore, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, silicon dioxide, and sulfur 12 [hp_X]/1; 12 [hp_X]/1; 6 [hp_X]/1; 3 [hp_X]/1; 12 [hp_X]/1; 12 [hp_X]/1; 6 [hp_X]/1 Tablet, Soluble — the drug itself is identical. This page's package is the 16-count one, while NDC 54973-3093-06 is the 4 tablets package.
What NDC number is used to bill for this package of Leg Cramps PM oyster shell calcium carbonate, crude, causticum, matricaria recutita, cinchona officinalis bark, copper, lycopodium clavatum spore, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, silicon dioxide, and sulfur 12 [hp_X]/1; 12 [hp_X]/1; 6 [hp_X]/1; 3 [hp_X]/1; 12 [hp_X]/1; 12 [hp_X]/1; 6 [hp_X]/1 Tablet, Soluble?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leg Cramps PM 12 [hp_X]/1; 12 [hp_X]/1; 6 [hp_X]/1; 3 [hp_X]/1; 12 [hp_X]/1; 12 [hp_X]/1; 6 [hp_X]this 54973-3093-08 Hyland's 16 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

🏛️
2010
On the market since
Jan 2010
📍
2026
Currently FDA-listed
16 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.

What it looks like

Color white
ShapeRound
Size9 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 5C5403N26O
    Acacia is a natural gum derived from acacia tree sap. It serves as a binder, thickener, and emulsifier to help hold ingredients together, improve texture, and stabilize the medicine.
  • 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.

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

The official label also statesAcacia Gum, Lactose.

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.

Manufacturer & labeler

LabelerHyland's Inc.
Labeler code54973
First marketedJan 2010
Product typeHuman Otc Drug
Portfolio69 products on file

More NDCs from Hyland's Inc. labeler code 54973

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.

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 📄 Ask a Doctor Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 25 words ▾

Uses* ■ Helps temporarily relieve symptoms of pain or cramps in lower body, legs, calves, feet or toes with accompanying occasional sleeplessness or disrupted sleep

⏱️ Dosage and Administration 53 words ▾

Directions ■ Use as directed. Adults and children 12 years and over Dissolve 2-3 tablets under tongue at bedtime. If the initial dosage is not providing immediate relief, dissolve 2-3 tablets under tongue every 15 minutes until relieved, up to 6 doses. Children under 12 years of age Ask a doctor before use.

⚠️ Warnings 44 words ▾

Warnings Ask a doctor before use if you are sensitive to quinine. Stop use and ask a doctor if symptoms persist for more than 7 days or worsen. If pregnant or breastfeeding Ask a health professional before use. Keep out of reach of children.

🧪 Active Ingredient 103 words ▾

Active ingredients Active Ingredients Purpose* Calcarea Carbonica 12X HPUS cramps in legs, calves, feet and toes Causticum 12X HPUS occasional sleeplessness Chamomilla 6X HPUS occasional sleeplessness Cinchona Officinalis 3X HPUS pain in limbs and joints; cramping in legs Cuprum Metallicum 12X HPUS cramps of limbs, charley horse cramps Lycopodium 12X HPUS disturbed, restless sleep Magnesia Phosphorica 6X HPUS muscle cramps Rhus Toxicodendron 6X HPUS pain and stiffness Silicea 12X HPUS not being able to sleep again after waking Sulphur 6X HPUS occasional sleeplessness, frequent waking during night “HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

🧪 Inactive Ingredients 5 words ▾

Inactive Ingredients Acacia Gum, Lactose.

🎯 Purpose 24 words ▾

Purpose Temporarily relieves the symptoms of pain and cramps in lower body, legs, calves, feet and toes with accompanying occasional sleeplessness and disrupted sleep.

📄 Ask a Doctor Before Use If 11 words ▾

Ask a doctor before use if you are sensitive to quinine.

📄 Stop Use and Ask a Doctor If 16 words ▾

Stop use and ask a doctor if symptoms persist for more than 7 days or worsen.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breastfeeding Ask a health professional before use.

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Other Information 10 words ▾

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

📄 Questions or Comments 4 words ▾

Questions? www.hylands.com or [email protected]

📄 Recent Major Changes 113 words ▾

Indications and Usage Dosage and Administration Updated Uses to:Temporarily relieves the symptoms of pain or cramps in lower body, legs, calves, feet or toes with accompanying occasional sleeplessness or disrupted sleep Updated Directions to: Adults and children 12 years and over Dissolve 2-3 tablets under tongue before bedtime. If the initial dosage is not providing relief, dissolve 2-3 tablets under tongue every 15 minutes, up to 6 doses. Under 12 years of age Consult a physician.

Indications and Usage Uses section...updated to "Helps temporarily relieve symptoms of pain or cramps in lower body, legs, calves, feet or toes with accompanying occasional sleeplessness or disrupted sleep"

Indications and Usage Added asterisk (*) to Uses

📄 Package Label / Principal Display Panel 41 words ▾

Principal Display Panel Hyland's LEG CRAMPS PM FAST + EFFECTIVE* #1 PHARMACIST RECOMENDED BEST OTC MEDICINE & HEALTH PRODUCTS & WORLD REPORT U.S. News 50 QUICK-DISSOLVING TABLETS HOMEOPATHIC LCPM00000T50LBLH2

Leg Cramps PM 16 Count Tablets Leg Cramps PM 16 Count Tablets

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

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 LEG CRAMPS PM (this brand).

Top reported reactions

Hyponatraemia1
Hypotension1
Loss Of Consciousness1
Mediastinal Mass1
Small Cell Lung Cancer1
Somnolence1
Urinary Retention1

Reporter sex

4 reports
Male · 67%
Female · 33%

Serious outcomes

Hospitalization1
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 1 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.

About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Leg Cramps PM oyster shell calcium carbonate, crude, causticum, matricaria recutita, cinchona officinalis bark, copper, lycopodium clavatum spore, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, silicon dioxide, and sulfur 12 [hp_X]/1; 12 [hp_X]/1; 6 [hp_X]/1; 3 [hp_X]/1; 12 [hp_X]/1; 12 [hp_X]/1; 6 [hp_X]/1 TABLET, SOLUBLE 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 4 tablets (54973-3093-06), 16 tablets (54973-3093-07), 30 tablets (54973-3093-02). 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?
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.
← 54973-3084-01 · Hyland's 54973-3108-01 · Hyland's →
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.