PAIN RELIEVER

Product NDC: 35192-002
11-digit product format: 351920002
Labeler code: 35192
Product ID: 35192-002_9e27a24a-d6dc-4d76-af32-f80588ae7b53
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: GEL
Route: TOPICAL
Labeler: CA-BOTANA INTERNATIONAL
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-08-24
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 2 g/120g
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	35192-002		I	Inactivated by FDA		2026-10-05
excluded package	package	35192-002	35192-002-02	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	35192-002-02	`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	35192-002-02	`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	35192-002-02	`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	35192-002-02	`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	35192-002-02	`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	35192-002-02	`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	35192-002-02	`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	35192-002-02	`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	35192-002-02	`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	35192-002-02	`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	35192-002-02	`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	35192-002-02	`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	35192-002-02	`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	35192-002-02	`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	35192-002-02	`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	35192-002-02	`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	35192-002-02	`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	35192-002-02	`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	35192-002-02	`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	35192-002-02	`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	35192-002-02	`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	35192-002-02	`110d247fa046…`	`a55b01930146…`

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
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
35192-002-02	2019-10-29	C162847	48780-1	960f7f55-d5c8-8e05-e053-dbdaa90a074a	GREEN MARVEL MASSAGE GEL WITH HERBAL EXTRACTS.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
35192-002-02	PAIN RELIEVER	120 g in 1 TUBE	GEL	120		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
ALOE FEROX LEAF	INACTIVE INGREDIENT	0D145J8EME	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
ARNICA MONTANA	INACTIVE INGREDIENT	O80TY208ZW	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
BROMELAINS	INACTIVE INGREDIENT	U182GP2CF3	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
CAPSICUM	INACTIVE INGREDIENT	00UK7646FG	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
CARBOMER COPOLYMER TYPE A	INACTIVE INGREDIENT	71DD5V995L	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
CHAMAEMELUM NOBILE	INACTIVE INGREDIENT	7NF3GE7IWR	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
DIMETHYL SULFONE	INACTIVE INGREDIENT	9H4PO4Z4FT	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
EDETIC ACID	INACTIVE INGREDIENT	9G34HU7RV0	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
ETHANOL	INACTIVE INGREDIENT	3K9958V90M	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
EUCALYPTUS GLOBULUS LEAF	INACTIVE INGREDIENT	S546YLW6E6	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
GLUCOSAMINE SULFATE	INACTIVE INGREDIENT	1FW7WLR731	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
HARPAGOPHYTUM PROCUMBENS ROOT	INACTIVE INGREDIENT	1OYM338E89	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
HORSE CHESTNUT	INACTIVE INGREDIENT	3C18L6RJAZ	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
MELISSA OFFICINALIS	INACTIVE INGREDIENT	YF70189L0N	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
ROSMARINUS OFFICINALIS FLOWER	INACTIVE INGREDIENT	NR1A27F29O	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
SALIX ALBA LEAF	INACTIVE INGREDIENT	M7S08QZ9JA	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
TILIA CORDATA FLOWER	INACTIVE INGREDIENT	CFN6G1F6YK	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35192-002	PAIN RELIEVER (MENTHOL) GEL [CA-BOTANA INTERNATIONAL]	6	Legacy NDC, 1 package rows	20110824_2162a3d3-ce3a-4ea3-9f50-c1c8673d8dea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311502	menthol 2 % Topical Gel	PSN	2162a3d3-ce3a-4ea3-9f50-c1c8673d8dea	6
311502	menthol 0.02 MG/MG Topical Gel	SCD	2162a3d3-ce3a-4ea3-9f50-c1c8673d8dea	6
311502	menthol 2 % Topical Gel	SY	2162a3d3-ce3a-4ea3-9f50-c1c8673d8dea	6
311502	menthol 2 % topical stick	SY	2162a3d3-ce3a-4ea3-9f50-c1c8673d8dea	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
35192-002-02	35192000202	120 g in 1 TUBE	120 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GREEN MARVEL MASSAGE GEL WITH HERBAL EXTRACTS.	CA-BOTANA INTERNATIONAL \| RODOLFO UGELSTAD	2011-08-24	HUMAN OTC DRUG LABEL	6