AleveX

Product NDC: 0280-0063
Requested package NDC: 0280-0063-01
11-digit product format: 002800063
Labeler code: 0280
Product ID: 0280-0063_45262976-7ea4-6a50-e063-6394a90a1c06
Type: HUMAN OTC DRUG
Nonproprietary name: camphor and menthol
Dosage form: LOTION
Route: TOPICAL
Labeler: Bayer HealthCare LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-04-01
Substance: CAMPHOR (SYNTHETIC); MENTHOL
Active strength: 5.5; 16 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: AleveX
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CAMPHOR (SYNTHETIC)	5.5 mg/g
MENTHOL	16 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5TJD82A1ET	Internal UNII lookup
L7T10EIP3A	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
bafdf06b-25f5-e29e-e053-2a95a90a5e1b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0280-0063-01	AleveX	77 g in 1 TUBE	LOTION	77		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0280-0063-01	GM - Gram	0280-0063	1a677620-824e-4cf5-ac3b-684fda94314c	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0280-0063	ALEVEX (CAMPHOR AND MENTHOL) LOTION [BAYER HEALTHCARE LLC]	4	Current NDC, Legacy NDC, 1 package rows	20241208_bafdf06b-25f5-e29e-e053-2a95a90a5e1b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 116 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hempvana Pain Relief	TROLAMINE SALICYLATE	Telebrands Corp	92a29553-a102-0a0e-e053-2a95a90ab24a	2024-11-20	Warnings	Exact identifier application number: M017
Ultra Strength Pain Relief Gel	MENTHOL	TELEBRANDS CORP	d91b2e09-550e-4968-e053-2995a90ae323	2024-11-20	Warnings	Exact identifier application number: M017
Hempvana Ultra Strength Pain Relief Cream	LIDOCAINE 4%	Telebrands Corp	c3162ba8-ac2d-5a65-e053-2995a90af246	2024-11-20	Warnings	Exact identifier application number: M017
Hempvana Ultra Strength Pain Relief	LIDOCAINE	TELEBRANDS CORP	d91ba9b1-083f-32e9-e053-2a95a90a9bd1	2024-11-20	Warnings	Exact identifier application number: M017
DynaRub	PAIN RELIEVING CREAM	Dynarex Corporation	7f853941-a2d7-ed26-e053-2991aa0aa9ee	2024-11-20	Warnings	Exact identifier application number: M017
MYCO Clinic Pain Relief	CAMPHOR, MENTHOL	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	bcdc0322-bc75-4662-9c5a-d1be1d055252	2024-11-20	Warnings	Exact identifier application number: M017
MYCO Clinic Pain Relief	MENTHOL	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	604a30c9-2306-47a1-bd31-94b63639dd90	2024-11-20	Warnings	Exact identifier application number: M017
MYCO Clinic Pain Relief	CAMPHOR, MENTHOL	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	0b489420-3b5c-43c5-aab4-0e3720acf9ce	2024-11-20	Warnings	Exact identifier application number: M017
MYCO Clinic Pain Relief	CAMPHOR, MENTHOL	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	dd906129-a787-4352-856d-d7a915031a6e	2024-11-20	Warnings	Exact identifier application number: M017
Walgreens Arthritis Pain Relief Cream	HISTAMINE DIHYDROCHLORIDE	Walgreens Company	80d3031a-7fa9-4f5b-b85e-c7c6ef314801	2024-11-20	Warnings	Exact identifier application number: M017
Anti-Itch Medicated Maximum Strength	BENZOCAINE AND RESORCINOL	Walgreens Company	7fd86dcb-edef-4d0d-b389-7ecea595fe67	2024-11-20	Warnings	Exact identifier application number: M017
Walgreens Pain Relief	BENZOCAINE	Walgreens Company	7cee7234-32cd-4bf3-8a6c-0882585eec7f	2024-11-20	Warnings	Exact identifier application number: M017
Walgreens Advanced Scar Gel	ADVANCED SCAR GEL	Walgreens Company	2c040475-a124-485c-933e-66b452f5ab46	2024-11-20	Warnings	Exact identifier application number: M017
LidoPro Pain Relief	CAPSAICIN AND LIDOCAINE	Clinic Pharma	274611ea-7fc2-ba3f-e063-6294a90aa50f	2024-11-19	Warnings	Exact identifier application number: M017
First Aid Only Sting Relief Pad	BENZOCAINE	Acme United Corporation	5087cbbd-1bbe-62ed-e054-00144ff8d46c	2024-11-19	Warnings	Exact identifier application number: M017
Sting Relief Pad	BENZOCAINE, ISOPROPYL ALCOHOL	Acme United Corporation	6bb9a782-2394-4c8c-e053-2991aa0a08d4	2024-11-19	Warnings	Exact identifier application number: M017
First Aid Only Sting Relief	BENZOCAINE	Acme United Corporation	697127d1-c02e-16d2-e053-2a91aa0a39fd	2024-11-19	Warnings	Exact identifier application number: M017
First Aid Only Hydrocortisone 1% Anti-Itch	HYDROCORTISONE	Acme United Corporation	e5597b11-b08e-99e1-e053-2a95a90a15a5	2024-11-19	Warnings	Exact identifier application number: M017
Equate Cold Therapy Pain Relieving Roll-on Analgesic	MENTHOL, UNSPECIFIED FORM	Wal-Mart Stores, Inc.	4115f0ac-e12a-4e59-94f5-a47dcc7f8766	2024-11-18	Warnings	Exact identifier application number: M017
Equate Cold Therapy Pain Relieving Analgesic	MENTHOL, UNSPECIFIED FORM	Wal-Mart Stores, Inc.	ac6c2112-8692-4628-97d8-3a5a9f509766	2024-11-18	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5TJD82A1ET	CAMPHOR (SYNTHETIC)	76-22-2	CAMPHOR (SYNTHETIC)

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0280-0063-01	00280006301	77 g in 1 TUBE (0280-0063-01)	77 g	2021-04-01	0000-00-00	No	No	Current