NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS

Product NDC
58368-002
11-digit product format
583680002
Labeler code
58368
Product ID
58368-002_4960b345-0a8e-7316-e063-6394a90abe8f
Type
HUMAN OTC DRUG
Nonproprietary name
topical gel for muscle cramping and restlessness
Dosage form
GEL
Route
TOPICAL
Labeler
BioLyte Laboratories, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-02-01
Substance
ARNICA MONTANA; ARTEMISIA CINA PRE-FLOWERING TOP; ATROPA BELLADONNA ROOT; BLACK COHOSH; CAUSTICUM; FRANGULA CALIFORNICA BARK; HYPERICUM PERFORATUM; JATROPHA CURCAS SEED; LYCOPODIUM CLAVATUM SPORE; POTASSIUM BROMIDE; POTASSIUM CARBONATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; SCUTELLARIA LATERIFLORA; STRYCHNOS IGNATII SEED; TARAXACUM OFFICINALE; VALERIAN; VERATRUM ALBUM ROOT
Active strength
4; 8; 4; 4; 4; 4; 4; 8; 4; 4; 4; 4; 4; 4; 4; 4; 8; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA4 [hp_X]/g
ARTEMISIA CINA PRE-FLOWERING TOP8 [hp_X]/g
ATROPA BELLADONNA ROOT4 [hp_X]/g
BLACK COHOSH4 [hp_X]/g
CAUSTICUM4 [hp_X]/g
FRANGULA CALIFORNICA BARK4 [hp_X]/g
HYPERICUM PERFORATUM4 [hp_X]/g
JATROPHA CURCAS SEED8 [hp_X]/g
LYCOPODIUM CLAVATUM SPORE4 [hp_X]/g
POTASSIUM BROMIDE4 [hp_X]/g
POTASSIUM CARBONATE4 [hp_X]/g
PSEUDOGNAPHALIUM OBTUSIFOLIUM4 [hp_X]/g
RUTA GRAVEOLENS FLOWERING TOP4 [hp_X]/g
SCUTELLARIA LATERIFLORA4 [hp_X]/g
STRYCHNOS IGNATII SEED4 [hp_X]/g
TARAXACUM OFFICINALE4 [hp_X]/g
VALERIAN8 [hp_X]/g
VERATRUM ALBUM ROOT8 [hp_X]/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO80TY208ZW, 28M1820ACT, 6MW97Q6E8M, K73E24S6X9, DD5FO1WKFU, 1LZ13MQR0S, XK4IUX8MNB, J0F5GM8LA8, C88X29Y479, OSD78555ZM, BQN1B9B9HA, 36XQ854NWW, N94C2U587S, 7BP4DH5PDC, 1NM3M2487K, 39981FM375, JWF5YAW3QW, QNS6W5US1Z

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58368-002-022024-10-16C16284748780-1ba0f9c33-562a-a910-e053-dadaa90a0b8546da3f0e-9dd1-6495-e054-00144ff8d46c
58368-002-022021-01-29C16284748780-1ba0f9c33-562a-a910-e053-dadaa90a0b8546da3f0e-9dd1-6495-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58368-002-02NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS56.7 g in 1 BOTTLE, PUMPGEL56.79

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58368-002NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS (TOPICAL GEL FOR MUSCLE CRAMPING AND RESTLESSNESS) GEL [BIOLYTE LABORATORIES, LLC]8Current NDC, Legacy NDC, 1 package rows20241018_46da3f0e-9dd1-6495-e054-00144ff8d46c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58368-002-025836800020256.7 g in 1 BOTTLE, PUMP (58368-002-02) 56.7 g2017-02-01NoNoCurrent