CeraVe Developed with Dermatologists Itch Relief Moisturizing

Product NDC: 49967-970
11-digit product format: 499670970
Labeler code: 49967
Product ID: 49967-970_ea7e8fa8-1b1c-46e5-88e5-b6a5f853ffc8
Type: HUMAN OTC DRUG
Nonproprietary name: pramoxine hydrochloride
Dosage form: LOTION
Route: TOPICAL
Labeler: L'Oreal USA Products Inc
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-08-17
Substance: PRAMOXINE HYDROCHLORIDE
Active strength: 1 mg/mL
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	1 mg/mL

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 SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
13ce57d0-b1c5-4685-ad7d-a562d9d8fc86	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304
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	SPL version
49967-970-01	CeraVe Developed with Dermatologists Itch Relief Moisturizing	237 mL in 1 BOTTLE, PUMP	LOTION	237	9
49967-970-02	CeraVe Developed with Dermatologists Itch Relief Moisturizing	15 in 1 TRAY	LOTION	15	9
49967-970-02	CeraVe Developed with Dermatologists Itch Relief Moisturizing	29.6 mL in 1 BOTTLE	LOTION	29.6	9
49967-970-03	CeraVe Developed with Dermatologists Itch Relief Moisturizing	473 mL in 1 BOTTLE	LOTION	473	9
49967-970-04	CeraVe Developed with Dermatologists Itch Relief Moisturizing	562 mL in 1 BOTTLE	LOTION	562	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49967-970-01	ML - Milliliter	49967-970	b98df13a-1797-40e8-b0d2-71f8aa29744c	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49967-970	CERAVE DEVELOPED WITH DERMATOLOGISTS ITCH RELIEF MOISTURIZING (PRAMOXINE HYDROCHLORIDE) LOTION [L'OREAL USA PRODUCTS INC]	8	Current NDC, Legacy NDC, 5 package rows	20240101_13ce57d0-b1c5-4685-ad7d-a562d9d8fc86.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 106 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Green Compass Reduce Pain Relief	CAMPHOR, MENTHOL, METHYL SALICYLATE	Green Compass, Inc.	0a0b688e-50f1-3eb1-e063-6394a90a7efa	2025-01-01	Warnings	Exact identifier application number: M017
Green Compass Reduce Topical Pain	CAMPHOR, MENTHOL, METHYL SALICYLATE	Green Compass, Inc.	8cb80362-5d24-1ee3-e053-2a95a90afcdf	2025-01-01	Warnings	Exact identifier application number: M017
Green Compass Reduce Roll-On Pain Relief	MENTHOL	Green Compass, Inc.	b5916aa2-428c-5637-e053-2995a90a08b0	2025-01-01	Warnings	Exact identifier application number: M017
OKeeffes Working Hands Pain Relief Skin Protectant	ALLANTOIN, LIDOCAINE HYDROCHLORIDE	The Gorilla Glue Company/O'Keeffe's Company	0685da25-c9fa-e1cd-e063-6394a90ae1b3	2025-01-01	Warnings	Exact identifier application number: M017
Icy Hot with Lidocaine Pain Relieving	LIDOCAINE HCL AND MENTHOL	Chattem, Inc.	75b28b06-77ea-4fea-b516-2e8a0dac7037	2025-01-01	Warnings	Exact identifier application number: M017
Advanced Seal Barrier plus Pain Relief	LIDOCAINE	Kericure Inc.	7ac95325-e6e9-4c56-9315-876c00af7c98	2025-01-01	Warnings	Exact identifier application number: M017
FixMySkin Healing Balm Fragrance-Free	HYDROCORTISONE	Lovely Skin, Inc.	c12af4c6-2f05-46ec-b901-1a4fcd750180	2024-12-31	Warnings	Exact identifier application number: M017
Pain Relieving Cream Lidocaine	BENZYL ALCOHOL, LIDOCAINE HCI	Trifecta Pharmaceuticals USA LLC	039a2036-54b2-cf28-e063-6294a90a8ce6	2024-12-31	Warnings	Exact identifier application number: M017
Cold Therapy Pain Relief Walgreens	MENTHOL 10.5%	WALGREEN COMPANY	f1daa68d-1b12-c28a-e053-2995a90a0949	2024-12-31	Warnings	Exact identifier application number: M017
Calypxo Pain Relief	METHYL SALICYLATE, MENTHOL	Advanced Rx of Tennessee, LLC	0b7736df-c7e0-7d00-e063-6294a90aa57e	2024-12-31	Warnings	Exact identifier application number: M017
New Terocin	METHYL SALICYLATE, CAPSAICIN, AND MENTHOL	Advanced Rx Pharmacy of Tennessee, LLC	f4bfc4a6-06ef-1f76-e053-2995a90a2b8f	2024-12-31	Warnings	Exact identifier application number: M017
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	01cb19a4-ce22-144d-e063-6294a90a8aa3	2024-12-31	Warnings	Exact identifier application number: M017
Satohap Lidocaine 4% Menthol 1% Pain Relieving Cream	LIDOCAINE, MENTHOL	Sato Pharmaceutical Co., Ltd.	2251e96b-d050-4ec2-a6b9-6659610885bf	2024-12-30	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	Safeway	af2e2ef3-0f3f-4592-8081-b6553ade2f5a	2024-12-26	Warnings	Exact identifier application number: M017
Comforte Menstrual Cramp Relief Cream	MENTHOL	PMS4PMS LLC	c121537e-3333-4f35-8c77-20086158dff4	2024-12-26	Warnings	Exact identifier application number: M017
N-Labs Arcticzen Pain Relief Knee	CAMPHOR (SYNTHETIC), MENTHOL	NUTRIOMO LABS PTE. LTD	05ee574a-854c-4a77-be77-082055075c4d	2024-12-26	Warnings	Exact identifier application number: M017
BiteMD External Analgesic First Aid Antiseptic	BENZOCAINE, CAMPHOR (SYNTHETIC), AND PHENOL	United Industries Corporation	4c60db03-6d2b-4ae0-a200-718b3a50eb0f	2024-12-23	Warnings	Exact identifier application number: M017
GNP Anti Itch	CAMPHOR, MENTHOL	AMERISOURCEBERGEN DRUG CORPORATION	b4f2d6f7-2287-47d8-e053-2995a90ae335	2024-12-23	Warnings	Exact identifier application number: M017
cool and heat pain relieving liquid	MENTHOL	Bionpharma Inc.	ec6f59d8-45c5-46a0-e053-2995a90a239f	2024-12-23	Warnings	Exact identifier application number: M017
FOOT WORKS MAXIMUM CRACKED HEEL	BENZALKONIUM CHLORIDE, LIDOCAINE	COSMAX USA, CORPORATION	29f92230-d1d4-5e94-e063-6294a90af812	2024-12-23	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49967-970-01	49967097001	237 mL in 1 BOTTLE, PUMP (49967-970-01)	237 ml	2017-08-17	0000-00-00	No	No	Current
49967-970-02	49967097002	15 BOTTLE in 1 TRAY (49967-970-02) / 29.6 mL in 1 BOTTLE	15 bottle	2017-08-17	0000-00-00	No	No	Current
49967-970-03	49967097003	473 mL in 1 BOTTLE (49967-970-03)	473 ml	2017-08-17	0000-00-00	No	No	Current
49967-970-04	49967097004	562 mL in 1 BOTTLE (49967-970-04)	562 ml	2017-08-17	0000-00-00	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 \| L'Oreal USA, Inc. \| Accupac, LLC	2026-05-12	HUMAN OTC DRUG LABEL	9