SUB-ZERO

Product NDC: 61611-107
11-digit product format: 616110107
Labeler code: 61611
Product ID: 61611-107_e7da1167-c151-4bf3-891a-076dc9fe08e6
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: GEL
Route: TOPICAL
Labeler: CURRENT SOLUTIONS LLC
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-12-29
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 4 g/100mL
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61611-107		D	Discontinued by firm	2026-08-11
excluded package	package	61611-107	61611-107-01	D	Discontinued by firm	2026-08-11
excluded package	package	61611-107	61611-107-03	D	Discontinued by firm	2026-08-11
excluded package	package	61611-107	61611-107-04	D	Discontinued by firm	2026-08-11
excluded package	package	61611-107	61611-107-16	D	Discontinued by firm	2026-08-11
excluded package	package	61611-107	61611-107-28	D	Discontinued by firm	2026-08-11

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 · 96 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	61611-107-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61611-107-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61611-107-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61611-107-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61611-107-01	`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	61611-107-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61611-107-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61611-107-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61611-107-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61611-107-01	`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	61611-107-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61611-107-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61611-107-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61611-107-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61611-107-01	`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	61611-107-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61611-107-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61611-107-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61611-107-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61611-107-01	`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	61611-107-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61611-107-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61611-107-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61611-107-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61611-107-01	`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	61611-107-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61611-107-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61611-107-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61611-107-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61611-107-01	`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	61611-107-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61611-107-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61611-107-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61611-107-28	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61611-107-01	`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	61611-107-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61611-107-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61611-107-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61611-107-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61611-107-01	`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	61611-107-16	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61611-107-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61611-107-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61611-107-28	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61611-107-01	`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	61611-107-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61611-107-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61611-107-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61611-107-28	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61611-107-01	`ad56d346431e…`	`cc804d4bbf1e…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
61611-107-01	2022-09-12	74cd6b0f-6141-4b0f-95cc-eb4e3605e20a
61611-107-03	2022-09-12	74cd6b0f-6141-4b0f-95cc-eb4e3605e20a
61611-107-04	2022-09-12	74cd6b0f-6141-4b0f-95cc-eb4e3605e20a
61611-107-16	2022-09-12	74cd6b0f-6141-4b0f-95cc-eb4e3605e20a
61611-107-28	2022-09-12	74cd6b0f-6141-4b0f-95cc-eb4e3605e20a
61611-107-01	2021-01-29	74cd6b0f-6141-4b0f-95cc-eb4e3605e20a
61611-107-03	2021-01-29	74cd6b0f-6141-4b0f-95cc-eb4e3605e20a
61611-107-04	2021-01-29	74cd6b0f-6141-4b0f-95cc-eb4e3605e20a
61611-107-16	2021-01-29	74cd6b0f-6141-4b0f-95cc-eb4e3605e20a
61611-107-28	2021-01-29	74cd6b0f-6141-4b0f-95cc-eb4e3605e20a

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	SUB-ZERO COOL PAIN RELIEVING (MENTHOL) GEL [CURRENT SOLUTIONS LLC]	3
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	SUB-ZERO COOL PAIN RELIEVING (MENTHOL) GEL [CURRENT SOLUTIONS LLC]	3
AMINOMETHYLPROPANOL	INACTIVE INGREDIENT	LU49E6626Q	SUB-ZERO COOL PAIN RELIEVING (MENTHOL) GEL [CURRENT SOLUTIONS LLC]	3
BOSWELLIA SERRATA RESIN OIL	INACTIVE INGREDIENT	5T1XCE6K8K	SUB-ZERO COOL PAIN RELIEVING (MENTHOL) GEL [CURRENT SOLUTIONS LLC]	3
CAMPHOR OIL	INACTIVE INGREDIENT	75IZZ8Y727	SUB-ZERO COOL PAIN RELIEVING (MENTHOL) GEL [CURRENT SOLUTIONS LLC]	3
CARBOMER 940	INACTIVE INGREDIENT	4Q93RCW27E	SUB-ZERO COOL PAIN RELIEVING (MENTHOL) GEL [CURRENT SOLUTIONS LLC]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SUB-ZERO COOL PAIN RELIEVING (MENTHOL) GEL [CURRENT SOLUTIONS LLC]	3
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	SUB-ZERO COOL PAIN RELIEVING (MENTHOL) GEL [CURRENT SOLUTIONS LLC]	3
ILEX PARAGUARIENSIS LEAF	INACTIVE INGREDIENT	1Q953B4O4F	SUB-ZERO COOL PAIN RELIEVING (MENTHOL) GEL [CURRENT SOLUTIONS LLC]	3
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	SUB-ZERO COOL PAIN RELIEVING (MENTHOL) GEL [CURRENT SOLUTIONS LLC]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SUB-ZERO COOL PAIN RELIEVING (MENTHOL) GEL [CURRENT SOLUTIONS LLC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SUB-ZERO COOL PAIN RELIEVING (MENTHOL) GEL [CURRENT SOLUTIONS LLC]	3
UNCARIA TOMENTOSA LEAF	INACTIVE INGREDIENT	487U8M3D2P	SUB-ZERO COOL PAIN RELIEVING (MENTHOL) GEL [CURRENT SOLUTIONS LLC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	SUB-ZERO COOL PAIN RELIEVING (MENTHOL) GEL [CURRENT SOLUTIONS LLC]	3

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SUB-ZERO COOL PAIN RELIEVING - CURRENT SOLUTIONS LLC	CURRENT SOLUTIONS LLC	2019-07-01	HUMAN OTC DRUG LABEL	4

SUB-ZERO

NDC auxiliary status#

Observed NDC auxiliary status history#

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Related Records#

Related DailyMed Labels#