FDA.reportPublic FDA data

Fibro Flex

Manufacturer
MAGNESIUM DIRECT INC.
Effective date
2015-07-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:06:47

Label at a glance#

ProductFibro Flex
Active ingredientMAGNESIUM CHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Magnesia Muriatica 1X HPUS

Purpose

OTC - PURPOSE SECTION

Joint and soft tissue pain

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INDICATIONS & USAGE SECTION

Uses Temporarily relieves the symptoms of Fibromyalgia pain.

WARNINGS SECTION

Warnings FOR EXTERNAL USE ONLY

If pregnant or breast feeding, ask a health professional before use. Consult a physician if symptoms persist for more than 7 days or worsen. Stop use if: Excessive irritation or burning of skin develops.

DOSAGE & ADMINISTRATION SECTION

Directions Apply 4-8 sprays to areas with Fibromyalgia pain on the body. Rub thoroughly. For convenience, spray into hand first, then apply. May be used multiple times daily. DO NOT use more than 100 sprays in a 24 hour period.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: water, calcium chloride, trace minerals.

OTC - QUESTIONS SECTION

Questions? 1-888-249-8574 M-F, 9-5, EST

Distributed by: Magnesium Direct

Alpharetta, GA 30005

WWW. FIBRO-FLEX.COM

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

magnes1magnes1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
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
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
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
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61495-401-042020-01-31C16284748780-19d75b9d1-21bd-f424-e053-dadaa90a57ceFibro Flex

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61495-401-04Fibro Flex118 mL in 1 BOTTLESPRAY1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61495-401FIBRO FLEX (MAGNESIA MURIATICA) SPRAY [MAGNESIUM DIRECT INC.]1Legacy NDC, 1 package rows20150721_be87ed5a-9cd3-423c-bee3-ac7207d6b9ec.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MAGNESIUM CHLORIDEACTIVE INGREDIENT02F3473H9O1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8381
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61495-40161495-401-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM CHLORIDE02F3473H9OACTIB
WATER059QF0KO0RIACT
CALCIUM CHLORIDEM4I0D6VV5MIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MCAPSULE / ORAL2 mgExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MINJECTION, SOLUTION / INTRAVENOUS11 mgExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MSOLUTION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MINJECTION, SOLUTION / INTRATHECAL1 mgExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MINJECTABLE, LIPOSOMAL / INTRAVENOUS0.03 %w/vExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MSOLUTION / INTRAOCULAR24 mgExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MINJECTION, SOLUTION / INTRAMUSCULAR0.01 %w/vExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MINJECTION, SOLUTION / INTRA-ARTERIAL11 mgExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MCONCENTRATE / ORAL0.08 mg/1mlExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MINJECTION, SUSPENSION / INTRAVITREAL0.05 %w/vExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MINJECTION / INFILTRATION0.33 mgExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MCAPSULE / RESPIRATORY (INHALATION)3 mgExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MINJECTION / INTRAVENOUS4 %w/vExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MSOLUTION / OPHTHALMIC1 mgExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MINJECTION / INTRAMUSCULAR4 %w/vExact identifier — unii candidate
16 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MSOLUTION / INTRAPERITONEAL0.03 %w/vExact identifier — unii candidate
16 equally ranked IID candidates

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
bb010f87-cfad-4deb-b8d3-bcefdf4f58acbe87ed5a-9cd3-423c-bee3-ac7207d6b9ec2015-07-11WarningsExact identifier
spl id: bb010f87-cfad-4deb-b8d3-bcefdf4f58ac
spl set id: be87ed5a-9cd3-423c-bee3-ac7207d6b9ec

Reported adverse events (FAERS/openFDA)#

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