Theraworx Relief for Muscle Cramps Roll On

Product NDC
61594-025
11-digit product format
615940025
Labeler code
61594
Product ID
61594-025_004bbcd7-9ac8-5809-e063-6294a90a2526
Type
HUMAN OTC DRUG
Nonproprietary name
MAGNESIUM SULFATE, UNSPECIFIED FORM
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
AVADIM HOLDINGS, INC.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-04-04
Substance
MAGNESIUM SULFATE, UNSPECIFIED FORM
Active strength
6 [hp_X]/mL
Pharmacologic classes
Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Theraworx Relief for Muscle Cramps Roll On
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM SULFATE, UNSPECIFIED FORM6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDE08037SAB

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
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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
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fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61594-025-00Theraworx Relief for Muscle Cramps Roll On74 mL in 1 BOTTLEAEROSOL, FOAM742

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61594-025THERAWORX RELIEF FOR MUSCLE CRAMPS ROLL ON (MAGNESIUM SULFATE, UNSPECIFIED FORM) AEROSOL, FOAM [AVADIM HOLDINGS, INC.]2Current NDC, 1 package rows20230713_464e8768-fe3f-435b-a8ba-f8567bc1506a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61594-025-006159400250074 mL in 1 BOTTLE (61594-025-00) 74 ml2022-04-04NoNoCurrent