THERAFREEZE

Product NDC: 57329-010
11-digit product format: 573290010
Labeler code: 57329
Product ID: 57329-010_b9cbc519-8615-43a5-939e-0e2763e2d5ee
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Astrum Pharma
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-08-08
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 60 mg/mL
NDC exclude flag: E
Listing certified through: 2017-12-31
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 product	product	57329-010		I	Inactivated by FDA		2026-10-05
excluded package	package	57329-010	57329-010-01	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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57329-010-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57329-010-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57329-010-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57329-010-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57329-010-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57329-010-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57329-010-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57329-010-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57329-010-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57329-010-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57329-010-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57329-010-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	57329-010-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	57329-010-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	57329-010-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	57329-010-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	57329-010-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	57329-010-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	57329-010-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	57329-010-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	57329-010-01	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	57329-010-01	`110d247fa046…`	`a55b01930146…`

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
57329-010-01	2019-11-27	C162847	48780-1	9855e2a2-3a0b-60a7-e053-dbdaa90a05bd	THERAFREZZE TM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57329-010-01	THERAFREEZE	473 mL in 1 TUBE	GEL	473		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
ARCTIUM LAPPA ROOT	INACTIVE INGREDIENT	597E9BI3Z3	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
ARNICA MONTANA FLOWER	INACTIVE INGREDIENT	OZ0E5Y15PZ	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
C13-14 ISOPARAFFIN	INACTIVE INGREDIENT	E4F12ROE70	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
CETEARYL OLIVATE	INACTIVE INGREDIENT	58B69Q84JO	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
CITRUS LIMON FRUIT OIL	INACTIVE INGREDIENT	0HNC1J1YED	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
DIMETHYL SULFONE	INACTIVE INGREDIENT	9H4PO4Z4FT	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
ILEX PARAGUARIENSIS LEAF	INACTIVE INGREDIENT	1Q953B4O4F	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
INDIAN FRANKINCENSE	INACTIVE INGREDIENT	4PW41QCO2M	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
LAURETH-7	INACTIVE INGREDIENT	Z95S6G8201	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
POLYACRYLAMIDE (10000 MW)	INACTIVE INGREDIENT	E2KR9C9V2I	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
SORBITAN OLIVATE	INACTIVE INGREDIENT	MDL271E3GR	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1
WITCH HAZEL	INACTIVE INGREDIENT	101I4J0U34	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57329-010	THERAFREEZE (MENTHOL) GEL [ASTRUM PHARMA]	1	Legacy NDC, 1 package rows	20131016_7660635b-db41-4bfa-95f2-ecb1837e4931.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
415976	menthol 6 % Topical Gel	PSN	7660635b-db41-4bfa-95f2-ecb1837e4931	1
1439987	THERAFREEZE 6 % Topical Gel	PSN	7660635b-db41-4bfa-95f2-ecb1837e4931	1
1439987	menthol 0.06 MG/MG Topical Gel [Therafreeze]	SBD	7660635b-db41-4bfa-95f2-ecb1837e4931	1
415976	menthol 0.06 MG/MG Topical Gel	SCD	7660635b-db41-4bfa-95f2-ecb1837e4931	1
415976	menthol 6 % Topical Gel	SY	7660635b-db41-4bfa-95f2-ecb1837e4931	1
1439987	Therafreeze 0.06 MG/MG Topical Gel	SY	7660635b-db41-4bfa-95f2-ecb1837e4931	1
1439987	Therafreeze 6 % Topical Gel	SY	7660635b-db41-4bfa-95f2-ecb1837e4931	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
57329-010-01	57329001001	473 mL in 1 TUBE	473 ml	Historical