AvaDerm

Product NDC: 65121-300
11-digit product format: 651210300
Labeler code: 65121
Product ID: 65121-300_617b4611-d476-c225-e053-2991aa0aaea1
Type: HUMAN OTC DRUG
Nonproprietary name: lidocaine hcl, menthol
Dosage form: CREAM
Route: TOPICAL
Labeler: Pure Source, LLC
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2015-06-10
Marketing end: 0000-00-00
Substance: LIDOCAINE HYDROCHLORIDE; MENTHOL
Active strength: 4 g/100g; g/100g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	65121-300		D	Discontinued by firm		2026-11-06
excluded package	package	65121-300	65121-300-01	D	Discontinued by firm		2026-11-06

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 · 20 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	65121-300-01	`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	65121-300-01	`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	65121-300-01	`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	65121-300-01	`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	65121-300-01	`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	65121-300-01	`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	65121-300-01	`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	65121-300-01	`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	65121-300-01	`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	65121-300-01	`ad56d346431e…`	`cc804d4bbf1e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LIDOCAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V13007Z41A	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2
LIDOCAINE	ACTIVE MOIETY	98PI200987	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2
ARNICA MONTANA FLOWER	INACTIVE INGREDIENT	OZ0E5Y15PZ	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2
C13-14 ISOPARAFFIN	INACTIVE INGREDIENT	E4F12ROE70	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2
CHONDROITIN SULFATE (BOVINE)	INACTIVE INGREDIENT	6IC1M3OG5Z	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2
DIMETHYL SULFONE	INACTIVE INGREDIENT	9H4PO4Z4FT	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2
EMU OIL	INACTIVE INGREDIENT	344821WD61	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2
GLUCOSAMINE SULFATE	INACTIVE INGREDIENT	1FW7WLR731	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2
GLYCERYL STEARATE SE	INACTIVE INGREDIENT	FCZ5MH785I	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2
LAURETH-7	INACTIVE INGREDIENT	Z95S6G8201	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2
POLYACRYLAMIDE (10000 MW)	INACTIVE INGREDIENT	E2KR9C9V2I	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2
UREA	INACTIVE INGREDIENT	8W8T17847W	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	AVADERM (LIDOCAINE HCL, MENTHOL) CREAM [PURE SOURCE, INC.]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65121-300-01	65121030001	120 g in 1 PACKAGE (65121-300-01)	120 g	2015-06-10	0000-00-00	No	No	Current

AvaDerm

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#