NeoRelief Wound Care

Product NDC
58368-006
Requested package NDC
58368-006-06
11-digit product format
583680006
Labeler code
58368
Product ID
58368-006_49613711-cad8-3b6a-e063-6394a90a7345
Type
HUMAN OTC DRUG
Nonproprietary name
Homeopathic healing cream
Dosage form
CREAM
Route
TOPICAL
Labeler
BioLyte Laboratories, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-04-27
Substance
ALTHAEA OFFICINALIS ROOT; CALENDULA OFFICINALIS FLOWERING TOP; DAPHNE MEZEREUM BARK; EQUISETUM ARVENSE TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; SALIX ALBA BARK; STELLARIA MEDIA; URTICA URENS
Active strength
3; 3; 3; 3; 3; 3; 3; 3; 2 [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 Wound Care
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALIX ALBA BARK3 [hp_X]/g
STELLARIA MEDIA3 [hp_X]/g
DAPHNE MEZEREUM BARK3 [hp_X]/g
URTICA URENS3 [hp_X]/g
ALTHAEA OFFICINALIS ROOT3 [hp_X]/g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK3 [hp_X]/g
HORSE CHESTNUT3 [hp_X]/g
CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]/g
EQUISETUM ARVENSE TOP2 [hp_X]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
205MXS71H7Internal UNII lookup
2H03479QVRInternal UNII lookup
X2N6E405GVInternal UNII lookup
IHN2NQ5OF9Internal UNII lookup
TRW2FUF47HInternal UNII lookup
T7S323PKJSInternal UNII lookup
3C18L6RJAZInternal UNII lookup
18E7415PXQInternal UNII lookup
1DP6Y6B65ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
71c4c9fd-e359-7c68-e053-2a95a90a3f68Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58368-006-062024-10-16C16284748780-1ba0f9c33-2422-a910-e053-dadaa90a0b8571c4c9fd-e359-7c68-e053-2a95a90a3f68
58368-006-062021-01-29C16284748780-1ba0f9c33-2422-a910-e053-dadaa90a0b8571c4c9fd-e359-7c68-e053-2a95a90a3f68

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58368-006-06NeoRelief Wound Care14.17 g in 1 BOTTLE, PUMPCREAM14.176

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58368-006NEORELIEF WOUND CARE (HOMEOPATHIC HEALING CREAM) CREAM [BIOLYTE LABORATORIES, LLC]4Current NDC, Legacy NDC, 1 package rows20241018_71c4c9fd-e359-7c68-e053-2a95a90a3f68.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 Wound CareHOMEOPATHIC HEALING CREAMBioLyte Laboratories, LLC71c4c9fd-e359-7c68-e053-2a95a90a3f682026-01-27WarningsExact identifier
ndc (package): 58368-006-06
ndc (product): 58368-006
ndc11 (package): 58368000606

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58368-006-065836800060614.17 g in 1 BOTTLE, PUMP (58368-006-06) 14.17 g2018-04-27NoNoCurrent