AleveX

Product NDC: 0280-0049
11-digit product format: 002800049
Labeler code: 0280
Product ID: 0280-0049_45261ca8-875e-7830-e063-6294a90ab33a
Type: HUMAN OTC DRUG
Nonproprietary name: camphor and menthol
Dosage form: SPRAY
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
bafd199a-e198-d5d1-e053-2995a90ad1cb	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0280-0049-01	AleveX	91 g in 1 CAN	SPRAY	91		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0280-0049	ALEVEX (CAMPHOR AND MENTHOL) SPRAY [BAYER HEALTHCARE LLC]	4	Current NDC, Legacy NDC, 1 package rows	20241208_bafd199a-e198-d5d1-e053-2995a90ad1cb.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 136 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Burn Relief	LIDOCAINE	Cardinal Health	f4e8e3b7-fd84-bdbc-e053-2a95a90aeab2	2024-02-06	Warnings	Exact identifier application number: M017
Pain Relieving Petro Carbo	PHENOL	J.R. Watkins, LLC.	050cf17d-3be7-45b9-8524-ad82af309a0e	2024-02-06	Warnings	Exact identifier application number: M017
White Cream	CAMPHOR (NATURAL) AND TURPENTINE OIL	J.R. Watkins, LLC.	e4de0734-59d5-478c-86ea-66fc2ba003e7	2024-02-05	Warnings	Exact identifier application number: M017
Pain Relieving Roll-On	MENTHOL, UNSPECIFIED FORM	Safetec of America, Inc.	80118260-9c88-402d-9a90-ecfe62b4b54f	2024-02-05	Warnings	Exact identifier application number: M017
Pain Relieving	MENTHOL, UNSPECIFIED FORM	Safetec of America, Inc.	df512ce6-ce1b-434d-9571-fb2e1d76e1d0	2024-02-05	Warnings	Exact identifier application number: M017
Pain Relieving	MENTHOL	Safetec of America, Inc.	52ebf64d-095f-467e-bf51-dd8d33b58c7d	2024-02-05	Warnings	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Safetec of America, Inc.	4f4c801b-d894-4fa3-b024-6ca41a5f2a95	2024-02-04	Warnings	Exact identifier application number: M017
Analgesic	MENTHOL	Safetec of America, Inc.	79e3b0e7-4ba5-4b9d-a980-5b6f18dba802	2024-02-04	Warnings	Exact identifier application number: M017
HAV EZ Penetrating Pain Relief	MENTHOL	PALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC	70006efc-9cc8-4490-b28c-fcb23b1737c4	2024-02-01	Warnings	Exact identifier application number: M017
Rugby Capsaicin External Analgesic	CAPSAICIN	Proficient Rx LP	7c733a30-5002-49e7-a6bd-7737a1d2461e	2024-02-01	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	ccb62898-b614-45b9-95ea-23e5e31893a8	2024-02-01	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE	Proficient Rx LP	0b26d92f-9d0e-46d4-a8bc-75d6da5f6199	2024-02-01	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Proficient Rx LP	c57d5f8e-5934-4cbb-999a-cdd55e5b105f	2024-02-01	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Proficient Rx LP	47e9fe84-bd0c-40ea-85de-e950bcacc557	2024-02-01	Warnings	Exact identifier application number: M017
Joint and Muscle Pain	MENTHOL	Shaklee Corporation	3943824f-1f4f-4d6f-bd73-0b1be02162a5	2024-01-30	Warnings	Exact identifier application number: M017
Mirakel Pain Relief Roll-On	LIDOCAINE HCL	Sanvio, Inc.	102f3618-13ad-37e3-e063-6294a90a8086	2024-01-30	Warnings	Exact identifier application number: M017
Blistex Lip Medex	PETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND PHENOL	Blistex Inc.	8ad39005-9419-4f1a-a1ae-2f76d212455e	2024-01-26	Warnings	Exact identifier application number: M017
Point Relief Cold Spot Pain Relieving	MENTHOL	Fabrication Enterprises	ad5d6f04-15e6-4548-95c2-32271c186bc1	2024-01-25	Warnings	Exact identifier application number: M017
MIND BODY MATRIX PAIN RELIEF	MENTHOL	Functional Energetic, Inc.	3667dd0d-942e-4101-ba98-cb013ae77cf5	2024-01-25	Warnings	Exact identifier application number: M017
SUPER WHITE STUFF Pain Relief	MENTHOL	BLUE SPRING WELLNESS	e6d27df5-118c-4c6d-86e8-7b4401a39c76	2024-01-23	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
0280-0049-01	00280004901	91 g in 1 CAN (0280-0049-01)	91 g	2021-04-01	0000-00-00	No	No	Current