No Pain More Gain

Product NDC: 69161-001
11-digit product format: 691610001
Labeler code: 69161
Product ID: 69161-001_99eb0620-bb08-5fa1-e053-2a95a90a03d9
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: CREAM
Route: TOPICAL
Labeler: Lugus Group LLC
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-08-29
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 10 mg/100mg
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69161-001		I	Inactivated by FDA	2026-10-16
excluded package	package	69161-001	69161-001-01	D	Discontinued by firm	2026-10-16
excluded package	package	69161-001	69161-001-02	I	Inactivated by FDA	2026-10-16

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 · 50 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69161-001-02	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69161-001-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69161-001-02	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69161-001-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69161-001-02	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69161-001-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69161-001-02	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69161-001-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69161-001-02	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69161-001-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69161-001-02	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69161-001-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69161-001-02	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69161-001-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69161-001-02	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69161-001-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69161-001-02	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69161-001-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69161-001-02	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69161-001-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69161-001-02	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69161-001-01	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69161-001-02	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69161-001-01	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69161-001-02	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69161-001-02	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69161-001-02	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69161-001-02	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69161-001-02	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69161-001-02	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69161-001-02	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69161-001-01	2021-01-29	C162847	48780-1	ba0f9c33-49a4-a910-e053-dadaa90a0b85	2db0b1a3-31c9-4b94-b905-9ff18d5b25e9
69161-001-02	2021-01-29	C162847	48780-1	ba0f9c33-49a4-a910-e053-dadaa90a0b85	2db0b1a3-31c9-4b94-b905-9ff18d5b25e9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69161-001-01	No Pain More Gain	100 mg in 1 PACKAGE	CREAM	100		23
69161-001-02	No Pain More Gain	150 mg in 1 PACKAGE	CREAM	150		23

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
ALMOND OIL	INACTIVE INGREDIENT	66YXD4DKO9	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE	INACTIVE INGREDIENT	FJ1H6M2JG9	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
CITRAL	INACTIVE INGREDIENT	T7EU0O9VPP	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
DEHYDROACETIC ACID	INACTIVE INGREDIENT	2KAG279R6R	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
DICAPRYLYL CARBONATE	INACTIVE INGREDIENT	609A3V1SUA	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
ETHYLHEXYL STEARATE	INACTIVE INGREDIENT	EG3PA2K3K5	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
GALACTOARABINAN	INACTIVE INGREDIENT	SL4SX1O487	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
GOLD	INACTIVE INGREDIENT	79Y1949PYO	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
LEMON OIL	INACTIVE INGREDIENT	I9GRO824LL	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
LIMONENE, (+)-	INACTIVE INGREDIENT	GFD7C86Q1W	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
LINALOOL, (+)-	INACTIVE INGREDIENT	F4VNO44C09	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)	INACTIVE INGREDIENT	255PIF62MS	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
PLATINUM	INACTIVE INGREDIENT	49DFR088MY	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
POLYAMINOPROPYL BIGUANIDE	INACTIVE INGREDIENT	322U039GMF	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
PPG-3 BENZYL ETHER MYRISTATE	INACTIVE INGREDIENT	8075L58MKO	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
SODIUM STEAROYL GLUTAMATE	INACTIVE INGREDIENT	65A9F4P024	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
SQUALANE	INACTIVE INGREDIENT	GW89575KF9	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
TETRASODIUM GLUTAMATE DIACETATE	INACTIVE INGREDIENT	5EHL50I4MY	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69161-001	NO PAIN MORE GAIN (MENTHOL) CREAM [LUGUS GROUP LLC]	23	Legacy NDC, 2 package rows	20191218_2db0b1a3-31c9-4b94-b905-9ff18d5b25e9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
69161-001-01	69161000101	100 mg in 1 PACKAGE	100 mg	Historical
69161-001-02	69161000102	150 mg in 1 PACKAGE	150 mg	Historical