Novo Pure Pain Relief Cream

Product NDC
58368-070
Requested package NDC
58368-070-02
11-digit product format
583680070
Labeler code
58368
Product ID
58368-070_d086e876-3691-a148-e053-2995a90ad914
Type
HUMAN OTC DRUG
Nonproprietary name
Actaea, Belladonna, Bryonia, Cimicifuga, Ledum, Rhododendron, Ruga Grav, Arnica, Salicylicum Ac, Bellis, Hypericum
Dosage form
CREAM
Route
TOPICAL
Labeler
BioLyte Laboratories, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-10-18
Marketing end
0000-00-00
Substance
ARNICA MONTANA; BLACK COHOSH; RHODODENDRON AUREUM LEAF; SALICYLIC ACID; ATROPA BELLADONNA ROOT; LEDUM PALUSTRE TWIG; ACTAEA SPICATA ROOT; BELLIS PERENNIS; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; BRYONIA ALBA ROOT
Active strength
3 [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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58368-07058368-070-02DDiscontinued by firm2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58368-070-022024-01-15C16284748780-1f386c649-cc1b-0266-e053-dadaa90a7c1a9fe37320-f810-a516-e053-2995a90ad61f
58368-070-022023-01-30C16284748780-1f386c649-cc1b-0266-e053-dadaa90a7c1a9fe37320-f810-a516-e053-2995a90ad61f

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58368-070-02583680070021 BOTTLE, PUMP in 1 CARTON (58368-070-02) > 56 g in 1 BOTTLE, PUMP2019-10-180000-00-00NoNoCurrent