CeraVe Developed with Dermatologists Itch Relief Moisturizing

Product NDC: 82046-620
11-digit product format: 820460620
Labeler code: 82046
Product ID: 82046-620_53ff6a6c-255b-b052-e063-6394a90ac688
Type: HUMAN OTC DRUG
Nonproprietary name: pramoxine hydrochloride
Dosage form: CREAM
Route: TOPICAL
Labeler: L'Oreal USA Products Inc
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-05-19
Substance: PRAMOXINE HYDROCHLORIDE
Active strength: 10 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: CeraVe Developed with Dermatologists Itch Relief Moisturizing
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRAMOXINE HYDROCHLORIDE	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
88AYB867L5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1052684	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
7c78d980-fc94-498c-aec5-464c0c76c8f4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82046-620-01	CeraVe Developed with Dermatologists Itch Relief Moisturizing	340 g in 1 JAR	CREAM	340		1
82046-620-02	CeraVe Developed with Dermatologists Itch Relief Moisturizing	453 g in 1 JAR	CREAM	453		1

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 135 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Cooling Pain Relief Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Cardinal Health, 110 dba LEADER	fd06d17f-4dff-42a9-a84f-904809ceb981	2024-03-13	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	EROS GLOBAL	b3495c95-ba4b-9459-e053-2a95a90a710f	2024-03-12	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	TRIFECTA PHARMACEUTICALS USA LLC	1369e70f-7a61-7078-e063-6394a90a9a88	2024-03-11	Warnings	Exact identifier application number: M017
Pain Reliever Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	130665d6-3de8-cb91-e063-6294a90a2083	2024-03-06	Warnings	Exact identifier application number: M017
Dermachange Aid Anti-Itch	DIPHENHYDRAMINE HCL	Private Label Beauty and Wellness	12ed906c-d028-0ff7-e063-6394a90aaa52	2024-03-05	Warnings	Exact identifier application number: M017
Dermachange Cold Therapy	MENTHOL	Private Label Beauty and Wellness	12ef7dd8-3da3-9c87-e063-6394a90ac924	2024-03-05	Warnings	Exact identifier application number: M017
Dermachange Arthritis Relief	TROLAMIN SALICYLATE	Private Beauty Label and Wellness	12dbfa50-1b97-f988-e063-6394a90a662c	2024-03-04	Warnings	Exact identifier application number: M017
Analgesic	MENTHOL	Safetec of America, Inc.	b0f4010c-995f-40e1-aa40-92760e697a61	2024-03-02	Warnings	Exact identifier application number: M017
Icy Hot Advanced Relief	CAMPHOR AND MENTHOL	Chattem, Inc.	9979ff36-415b-44e4-bb10-6bf682cd00f9	2024-03-01	Warnings	Exact identifier application number: M017
Amish Origins Pain Relieving Menthol 8%	MENTHOL	Amish Origins Management, LLC	5051b650-18a4-481e-a8d7-d41d4ae51efd	2024-02-29	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	TRIFECTA PHARMACEUTICALS USA LLC	2999fecb-cb15-4023-ade4-ab5822b094d5	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Pain Relieving Menthol 8	MENTHOL	Amish Origins Management, LLC	aaad56d5-6737-4edc-af0e-8e207695c0ec	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Pain Relieving Menthol 8%	MENTHOL	Amish Origins Management, LLC	b120404f-5a07-4182-bb50-d943418622da	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Topical Analgesic Camphor 2%	CAMPHOR (SYNTHETIC)	Amish Origins Management, LLC	437491ca-60ff-4508-b408-f97e7152f638	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Topical Analgesic Camphor 2%	CAMPHOR (SYNTHETIC)	Amish Origins Management, LLC	ffe15aed-ea90-4db8-aace-d691a81c05ae	2024-02-29	Warnings	Exact identifier application number: M017
LidoPro Patch	LIDOCAINE, MENTHOL, AND METHYL SALICYLATE	Advanced Rx Pharmacy of Tennessee, LLC	128d0ba9-bc9d-af16-e063-6394a90af5ef	2024-02-29	Warnings	Exact identifier application number: M017
Leader Roll-On Cooling Pain Relief Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Cardinal Health, 110 dba LEADER	e86cba40-6b10-454d-98b3-6b547456eaad	2024-02-29	Warnings	Exact identifier application number: M017
Maximum Strength Scalp Itch Relief Anti-itch	HYDROCORTISONE	Rite Aid	55569563-fc38-4f97-8e74-9f96e3173384	2024-02-28	Warnings	Exact identifier application number: M017
Walgreens Eczema Relief	HYDROCORTISONE ACETATE	Walgreen Co.	4a65a1bf-aa24-4452-9ec3-a28c8bf0e47c	2024-02-28	Warnings	Exact identifier application number: M017
meijer Cold Therapy Pain Relieving analgesic	MENTHOL, UNSPECIFIED FORM	Meijer Distribution, Inc	fb163112-d84d-418d-a410-3214c0ee4b5a	2024-02-28	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1052684	Pramoxine (Topical)	pramoxine hydrochloride 10 MG/ML Topical Cream	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1052684	pramoxine HCl 1 % Topical Cream	PSN	7c78d980-fc94-498c-aec5-464c0c76c8f4	1
1052684	pramoxine hydrochloride 10 MG/ML Topical Cream	SCD	7c78d980-fc94-498c-aec5-464c0c76c8f4	1
1052684	pramoxine hydrochloride 1 % Topical Cream	SY	7c78d980-fc94-498c-aec5-464c0c76c8f4	1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1052684	pramoxine HCl 1 % Topical Cream	PSN	7c78d980-fc94-498c-aec5-464c0c76c8f4	1
1052684	pramoxine hydrochloride 10 MG/ML Topical Cream	SCD	7c78d980-fc94-498c-aec5-464c0c76c8f4	1
1052684	pramoxine hydrochloride 1 % Topical Cream	SY	7c78d980-fc94-498c-aec5-464c0c76c8f4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82046-620-01	82046062001	340 g in 1 JAR (82046-620-01)	340 g	2026-05-19	No	No	Current
82046-620-02	82046062002	453 g in 1 JAR (82046-620-02)	453 g	2026-05-19	No	No	Current
82046-620-03	82046062003	539 g in 1 JAR (82046-620-03)	539 g	2026-06-11	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	L'Oreal USA Products Inc \| L'OREAL USA PRODUCTS, INC.	2026-06-11	HUMAN OTC DRUG LABEL	2

CeraVe Developed with Dermatologists Itch Relief Moisturizing

Reported adverse events (FAERS/openFDA)#

Additional Listing Data#

Active Ingredients#

Harmonized UNII identifiers#

Harmonized RxCUI identifiers#

Harmonized SPL set identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

openFDA label cross-check#

Related Records#

Related UNII Ingredients#

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#