RelieveIt Regenerating Gel

Product NDC: 58133-952
Requested package NDC: 58133-952-37
11-digit product format: 581330952
Labeler code: 58133
Product ID: 58133-952_78d37379-7715-c444-e053-2a91aa0a789b
Type: HUMAN OTC DRUG
Nonproprietary name: Arnica montana, Calendula officinalis, Boswellia serrata, Harpagophytum procumbens, Kalanchoe Pinnata
Dosage form: GEL
Route: TOPICAL
Labeler: Cosmetic Specialty Labs, Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2018-10-17
Marketing end: 0000-00-00
Substance: BOSWELLIA SERRATA RESIN OIL; ARNICA MONTANA; KALANCHOE PINNATA LEAF; HARPAGOPHYTUM PROCUMBENS ROOT; CALENDULA OFFICINALIS SEED OIL
Active strength: 2 [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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	58133-952	58133-952-37	I	Inactivated by FDA		2026-10-05

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58133-952-16	2024-01-30	C162847	48780-1	1030e365-6c64-111a-e063-dadaa90a10e2	RelieveIt Regenerating Gel
58133-952-37	2024-01-30	C162847	48780-1	1030e365-6c64-111a-e063-dadaa90a10e2	RelieveIt Regenerating Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58133-952-16	RelieveIt Regenerating Gel	474 mL in 1 BOTTLE, PUMP	GEL	474		2
58133-952-37	RelieveIt Regenerating Gel	3780 mL in 1 BOTTLE, PUMP	GEL	3780		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58133-952	RELIEVEIT REGENERATING GEL (ARNICA MONTANA, CALENDULA OFFICINALIS, BOSWELLIA SERRATA, HARPAGOPHYTUM PROCUMBENS, KALANCHOE PINNATA) GEL [COSMETIC SPECIALTY LABS, INC.]	2	Legacy NDC, 2 package rows	20181023_787129c2-724d-d190-e053-2a91aa0ac6ff.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O80TY208ZW	ARNICA MONTANA	8057-65-6	ARNICA MONTANA
3R963LO08T	KALANCHOE PINNATA LEAF		KALANCHOE PINNATA LEAF
1OYM338E89	HARPAGOPHYTUM PROCUMBENS ROOT		HARPAGOPHYTUM PROCUMBENS ROOT
9JS8DS42SV	CALENDULA OFFICINALIS SEED OIL		CALENDULA OFFICINALIS SEED OIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58133-952-37	58133095237	3780 mL in 1 BOTTLE, PUMP (58133-952-37)	3780 ml	2018-10-17	0000-00-00	No	No	Current