FDA.reportPublic FDA data

Leg Cramp and Spasm Relief

Manufacturer
King Bio Inc.
Effective date
2016-03-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:07:34

Label at a glance#

ProductLeg Cramp and Spasm Relief
Active ingredientOYSTER SHELL CALCIUM CARBONATE, CRUDE, COPPER, PSEUDOGNAPHALIUM OBTUSIFOLIUM, HYOSCYAMUS NIGER, STRYCHNOS IGNATII SEED, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, STRYCHNOS NUX-VOMICA SEED, PASSIFLORA INCARNATA FLOWERING TOP, PLATINUM, LEAD, CLAVICEPS PURPUREA SCLEROTIUM, STRYCHNINE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: Calcarea carbonica, Cuprum metallicum, Gnaphalium polycephalum, Hyoscyamus niger, Ignatia amara, Magnesia phosphorica, Nux vomica, Passiflora incarnata, Platinum metallicum, Plumbum metallicum, Secale cornutum, Strychninum. Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

INDICATIONS & USAGE SECTION

Uses for temporary relief of: cramps and spasms in the legs, calves, feet, or hands that occur while resting, at night, or from athletic overexertion.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

WARNINGS SECTION

Warnings

  • Stop use and ask a doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, ask a healthcare professional before ues.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Ages 12 and up: 3 sprays 3 times per day.
  • Ages 2-12: 2 sprays 3 times per day.

OTHER SAFETY INFORMATION

Tamper resistant for your protection. Use only if safety seal is intact.

OTC - PURPOSE SECTION

Uses for temporary relief of:

  • cramps and spasms in the legs, calves, feet, or hands that occur while resting, at night, or from athletic overexertion.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-6035-22020-01-31C16284748780-19d75b9cf-db32-f424-e053-dadaa90a57ceLeg Cramps & Spasm Relief™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-6035-2Leg Cramp and Spasm Relief59 mL in 1 BOTTLE, SPRAYLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-6035LEG CRAMP AND SPASM RELIEF (CALCAREA CARBONICA, CUPRUM METALLICUM, GNAPHALIUM POLYCEPHALUM, HYOSCYAMUS NIGER, IGNATIA AMARA, MAGNESIA PHOSPHORICA, NUX VOMICA, PASSIFLORA INCARNATA, PLATINUM METALLICUM, PLUMBUM METALLICUM, SECALE CORNUTUM, STRYCHNINUM) LIQUID [KING BIO INC.]1Legacy NDC, 1 package rows20160323_bc31e919-e92f-4d4e-8dae-cc2fd93dc78d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-603557955-6035-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
COPPER789U1901C5ACTIB
PSEUDOGNAPHALIUM OBTUSIFOLIUM36XQ854NWWACTIB
HYOSCYAMUS NIGER4WRK2153H3ACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
PLATINUM49DFR088MYACTIB
LEAD2P299V784PACTIB
CLAVICEPS PURPUREA SCLEROTIUM01G9XEA93NACTIB
STRYCHNINEH9Y79VD43JACTIB
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5e4dfbce-de1a-413d-8a53-4bb40e9d66f8bc31e919-e92f-4d4e-8dae-cc2fd93dc78d2016-03-22WarningsExact identifier
spl id: 5e4dfbce-de1a-413d-8a53-4bb40e9d66f8
spl set id: bc31e919-e92f-4d4e-8dae-cc2fd93dc78d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.