RelieveIt Gel Max

Product NDC
58133-953
Requested package NDC
58133-953-02
11-digit product format
581330953
Labeler code
58133
Product ID
58133-953_786e68a2-3b55-519f-e053-2a91aa0acf83
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica montana, Calendula officinalis, Camphora (Camphor), Capsaicum Oleoresin (Capsaicin), Mentha piperita (Peppermint)
Dosage form
GEL
Route
TOPICAL
Labeler
Cosmetic Specialty Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-08-15
Marketing end
0000-00-00
Substance
CAMPHOR (NATURAL); ARNICA MONTANA; MENTHA PIPERITA; CAPSAICIN; CALENDULA OFFICINALIS SEED OIL
Active strength
7 [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage58133-95358133-953-02IInactivated by FDA2026-08-03

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 · 15 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…
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…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-953-022024-01-30C16284748780-11030e365-0e7e-111a-e063-dadaa90a10e2RelieveIt Gel Max
58133-953-162024-01-30C16284748780-11030e365-0e7e-111a-e063-dadaa90a10e2RelieveIt Gel Max
58133-953-372024-01-30C16284748780-11030e365-0e7e-111a-e063-dadaa90a10e2RelieveIt Gel Max

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-953-02RelieveIt Gel Max70 mL in 1 BOTTLE, PUMPGEL701
58133-953-16RelieveIt Gel Max474 mL in 1 BOTTLE, PUMPGEL4741
58133-953-37RelieveIt Gel Max3780 mL in 1 BOTTLE, PUMPGEL37801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-953RELIEVEIT GEL MAX (ARNICA MONTANA, CALENDULA OFFICINALIS, CAMPHORA (CAMPHOR), CAPSAICUM OLEORESIN (CAPSAICIN), MENTHA PIPERITA (PEPPERMINT)) GEL [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 3 package rows20181018_786e68a2-3b54-519f-e053-2a91aa0acf83.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58133-953-025813309530270 mL in 1 BOTTLE, PUMP (58133-953-02) 70 ml2018-08-150000-00-00NoNoCurrent