FDA.reportPublic FDA data

NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS

Product NDC
58368-002
Requested package NDC
58368-002-02
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 18 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
DD5FO1WKFUInternal UNII lookup
J0F5GM8LA8Internal UNII lookup
1LZ13MQR0SInternal UNII lookup
N94C2U587SInternal UNII lookup
O80TY208ZWInternal UNII lookup
6MW97Q6E8MInternal UNII lookup
K73E24S6X9Internal UNII lookup
28M1820ACTInternal UNII lookup
36XQ854NWWInternal UNII lookup
XK4IUX8MNBInternal UNII lookup
1NM3M2487KInternal UNII lookup
OSD78555ZMInternal UNII lookup
BQN1B9B9HAInternal UNII lookup
C88X29Y479Internal UNII lookup
7BP4DH5PDCInternal UNII lookup
39981FM375Internal UNII lookup
JWF5YAW3QWInternal UNII lookup
QNS6W5US1ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
46da3f0e-9dd1-6495-e054-00144ff8d46cAvailable on FDA.report

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

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
NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESSTOPICAL GEL FOR MUSCLE CRAMPING AND RESTLESSNESSBioLyte Laboratories, LLC46da3f0e-9dd1-6495-e054-00144ff8d46c2026-01-27WarningsExact identifier
ndc (package): 58368-002-02
ndc (product): 58368-002
ndc11 (package): 58368000202

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