Berri-Freez

Product NDC: 54162-009
11-digit product format: 541620009
Labeler code: 54162
Product ID: 54162-009_d12523bd-332d-4b19-b05f-0a4a2f3b5c86
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Geritrex LLC
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2015-07-31
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 5 g/113g
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	54162-009		I	Inactivated by FDA	2026-10-15
excluded package	package	54162-009	54162-009-04	I	Inactivated by FDA	2026-10-15
excluded package	package	54162-009	54162-009-16	I	Inactivated by FDA	2026-10-15

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 2 · 63 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	54162-009-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54162-009-16	`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	54162-009-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54162-009-16	`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	54162-009-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54162-009-16	`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	54162-009-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54162-009-16	`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	54162-009-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54162-009-16	`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	54162-009-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54162-009-16	`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	54162-009-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54162-009-16	`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	54162-009-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54162-009-16	`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	54162-009-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54162-009-16	`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	54162-009-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54162-009-16	`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	54162-009-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54162-009-16	`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	54162-009-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54162-009-16	`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	54162-009-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54162-009-16	`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	54162-009-04	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54162-009-16	`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	54162-009-04	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54162-009-16	`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	54162-009-04	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	54162-009-16	`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	54162-009-04	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	54162-009-16	`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	54162-009-04	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	54162-009-16	`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	54162-009-04	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	54162-009-16	`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	54162-009-04	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54162-009-16	`e2bbac7714bc…`	`27bdfed8d636…`

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54162-009-04	2020-01-31	C162847	48780-1	9d75b9d0-0679-f424-e053-dadaa90a57ce	Berri-Freez
54162-009-16	2020-01-31	C162847	48780-1	9d75b9d0-0679-f424-e053-dadaa90a57ce	Berri-Freez

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54162-009-04	Berri-Freez	113 g in 1 TUBE	GEL	113		4
54162-009-16	Berri-Freez	454 g in 1 BOTTLE, PUMP	GEL	454		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54162-009-04	GM - Gram	54162-009	40026d8d-7d1d-4222-9f11-8fb270183a4a	1	2013-10-17
54162-009-16	ML - Milliliter	54162-009	f6d7ae15-133f-49ed-b280-4abb7eb8f221	1	2016-11-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	BERRI-FREEZ (MENTHOL) GEL [GERITREX CORP]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	BERRI-FREEZ (MENTHOL) GEL [GERITREX CORP]	2
CAMPHOR (SYNTHETIC)	INACTIVE INGREDIENT	5TJD82A1ET	BERRI-FREEZ (MENTHOL) GEL [GERITREX CORP]	2
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	BERRI-FREEZ (MENTHOL) GEL [GERITREX CORP]	2
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	BERRI-FREEZ (MENTHOL) GEL [GERITREX CORP]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	BERRI-FREEZ (MENTHOL) GEL [GERITREX CORP]	2
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	BERRI-FREEZ (MENTHOL) GEL [GERITREX CORP]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BERRI-FREEZ (MENTHOL) GEL [GERITREX CORP]	2
ILEX PARAGUARIENSIS LEAF	INACTIVE INGREDIENT	1Q953B4O4F	BERRI-FREEZ (MENTHOL) GEL [GERITREX CORP]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	BERRI-FREEZ (MENTHOL) GEL [GERITREX CORP]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BERRI-FREEZ (MENTHOL) GEL [GERITREX CORP]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BERRI-FREEZ (MENTHOL) GEL [GERITREX CORP]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BERRI-FREEZ (MENTHOL) GEL [GERITREX CORP]	2
THYME	INACTIVE INGREDIENT	CW657OBU4N	BERRI-FREEZ (MENTHOL) GEL [GERITREX CORP]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	BERRI-FREEZ (MENTHOL) GEL [GERITREX CORP]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	BERRI-FREEZ (MENTHOL) GEL [GERITREX CORP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54162-009	BERRI-FREEZ (MENTHOL) GEL [GERITREX LLC]	4	Legacy NDC, 2 package rows	20161020_3e7d643b-33a3-416b-b289-9e4b58c797e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1363900	Berri-Freez 4.5 % Topical Gel	PSN	3e7d643b-33a3-416b-b289-9e4b58c797e1	4
1313823	menthol 4.5 % Topical Gel	PSN	3e7d643b-33a3-416b-b289-9e4b58c797e1	4
1363900	menthol 0.045 MG/MG Topical Gel [Berri-Freez]	SBD	3e7d643b-33a3-416b-b289-9e4b58c797e1	4
1313823	menthol 0.045 MG/MG Topical Gel	SCD	3e7d643b-33a3-416b-b289-9e4b58c797e1	4
1363900	Berri-Freez 0.045 MG/MG Topical Gel	SY	3e7d643b-33a3-416b-b289-9e4b58c797e1	4
1363900	Berri-Freez 4.5 % Topical Gel	SY	3e7d643b-33a3-416b-b289-9e4b58c797e1	4
1363900	Berri-Freez 4.5 GM per 100 GM	SY	3e7d643b-33a3-416b-b289-9e4b58c797e1	4
1313823	menthol 4.5 % Topical Gel	SY	3e7d643b-33a3-416b-b289-9e4b58c797e1	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
54162-009-04	54162000904	113 g in 1 TUBE	113 g	Historical
54162-009-16	54162000916	454 g in 1 BOTTLE, PUMP	454 g	Historical