Control Menstrual Cramp Relief

Product NDC: 58133-010
Requested package NDC: 58133-010-03
11-digit product format: 581330010
Labeler code: 58133
Product ID: 58133-010_c9f0a39a-fedb-200f-e053-2995a90aa888
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: CREAM
Route: TOPICAL
Labeler: Cosmetic Specialty Labs, Inc.
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2021-03-04
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 3 g/100mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	58133-010	58133-010-03	D	Discontinued by firm		2026-10-05
excluded package	package	58133-010	58133-010-03	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 · 27 matching rows.

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

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

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
NDC	Effective	Action	Document	Indexing SPL	Related label
58133-010-01	2024-07-30	C162847	48780-1	1e7a6dab-1d27-a2ce-e063-dadaa90aadf7	KRT packet
58133-010-03	2024-01-30	C162847	48780-1	1030e365-14de-111a-e063-dadaa90a10e2	c9f0a39a-feda-200f-e053-2995a90aa888

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58133-010-01	Control Menstrual Cramp Relief	7.5 mL in 1 PACKET	CREAM	7.5		1
58133-010-03	Control Menstrual Cramp Relief	89 mL in 1 TUBE	CREAM	89		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58133-010-03	ML - Milliliter	58133-010	9da76123-c615-425e-adac-c084d8b112e1	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58133-010	CONTROL MENSTRUAL CRAMP RELIEF (MENTHOL) CREAM [COSMETIC SPECIALTY LABS, INC.]	1	Legacy NDC, 1 package rows	20210821_c9f0a39a-feda-200f-e053-2995a90aa888.zip
58133-010	CONTROL MENSTRUAL CRAMP RELIEF (MENTHOL) CREAM [COSMETIC SPECIALTY LABS, INC.]	1	Legacy NDC, 1 package rows	20230525_fc73dde9-9df4-beca-e053-6394a90aaf0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1442261	menthol 3 % Topical Cream	PSN	c9f0a39a-feda-200f-e053-2995a90aa888	1
1442261	menthol 3 % Topical Cream	PSN	fc73dde9-9df4-beca-e053-6394a90aaf0d	1
1442261	menthol 30 MG/ML Topical Cream	SCD	c9f0a39a-feda-200f-e053-2995a90aa888	1
1442261	menthol 30 MG/ML Topical Cream	SCD	fc73dde9-9df4-beca-e053-6394a90aaf0d	1
1442261	menthol 3 % Topical Cream	SY	c9f0a39a-feda-200f-e053-2995a90aa888	1
1442261	menthol 3 % Topical Cream	SY	fc73dde9-9df4-beca-e053-6394a90aaf0d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58133-010-03	58133001003	89 mL in 1 TUBE (58133-010-03)	89 ml	2021-03-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
KRT packet	Cosmetic Specialty Labs, Inc.	2023-05-24	HUMAN OTC DRUG LABEL	1
Control Menstrual Cramp Relief - Cosmetic Specialty Labs, Inc.	Cosmetic Specialty Labs, Inc.	2021-08-19	HUMAN OTC DRUG LABEL	1