FDA.reportPublic FDA data

NEORELIEF FOR PAIN

Product NDC
58368-005
11-digit product format
583680005
Labeler code
58368
Product ID
58368-005_4961467c-1d4d-20ce-e063-6394a90a2445
Type
HUMAN OTC DRUG
Nonproprietary name
topical gel for pain
Dosage form
GEL
Route
TOPICAL
Labeler
BioLyte Laboratories, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2017-02-01
Substance
ACTAEA SPICATA ROOT; ALTHAEA OFFICINALIS ROOT; ARNICA MONTANA; ATROPA BELLADONNA ROOT; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CAULOPHYLLUM THALICTROIDES ROOT; CAUSTICUM; FRANGULA CALIFORNICA BARK; GUAIACUM OFFICINALE RESIN; HORSE CHESTNUT; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; LITHIUM CARBONATE; POTASSIUM CARBONATE; RHODODENDRON AUREUM LEAF; RUTA GRAVEOLENS FLOWERING TOP; SALICYLIC ACID; STELLARIA MEDIA; TOXICODENDRON PUBESCENS LEAF
Active strength
4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4 [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; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
Pharmacologic classes
Mood Stabilizer [EPC]
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 PAIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACTAEA SPICATA ROOT4 [hp_X]/g
ALTHAEA OFFICINALIS ROOT4 [hp_X]/g
ARNICA MONTANA4 [hp_X]/g
ATROPA BELLADONNA ROOT4 [hp_X]/g
BELLIS PERENNIS4 [hp_X]/g
BLACK COHOSH4 [hp_X]/g
BRYONIA ALBA ROOT4 [hp_X]/g
CALENDULA OFFICINALIS FLOWERING TOP4 [hp_X]/g
CAULOPHYLLUM THALICTROIDES ROOT4 [hp_X]/g
CAUSTICUM4 [hp_X]/g
FRANGULA CALIFORNICA BARK4 [hp_X]/g
GUAIACUM OFFICINALE RESIN4 [hp_X]/g
HORSE CHESTNUT4 [hp_X]/g
HYPERICUM PERFORATUM4 [hp_X]/g
LEDUM PALUSTRE TWIG4 [hp_X]/g
LITHIUM CARBONATE4 [hp_X]/g
POTASSIUM CARBONATE4 [hp_X]/g
RHODODENDRON AUREUM LEAF4 [hp_X]/g
RUTA GRAVEOLENS FLOWERING TOP4 [hp_X]/g
SALICYLIC ACID4 [hp_X]/g
STELLARIA MEDIA4 [hp_X]/g
TOXICODENDRON PUBESCENS LEAF4 [hp_X]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3FU86L9OS0, TRW2FUF47H, O80TY208ZW, 6MW97Q6E8M, 2HU33I03UY, K73E24S6X9, T7J046YI2B, 18E7415PXQ, JTJ6HH6YEH, DD5FO1WKFU, 1LZ13MQR0S, N0K2Z502R6, 3C18L6RJAZ, XK4IUX8MNB, 877L01IZ0P, 2BMD2GNA4V, BQN1B9B9HA, IV92NQJ73U, N94C2U587S, O414PZ4LPZ

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58368-005-01NEORELIEF FOR PAIN1 in 1 CARTONGEL112
58368-005-01NEORELIEF FOR PAIN56.7 g in 1 BOTTLE, PUMPGEL56.712

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58368-005NEORELIEF FOR PAIN (TOPICAL GEL FOR PAIN) GEL [BIOLYTE LABORATORIES, LLC]11Current NDC, Legacy NDC, 2 package rows20241010_46df076d-4e3a-6faa-e054-00144ff8d46c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58368-005-01583680005011 BOTTLE, PUMP in 1 CARTON (58368-005-01) / 56.7 g in 1 BOTTLE, PUMP2017-02-010000-00-00NoNoCurrent