Home NDC 49967-970 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 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 96 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NOVUM APR MENTHOL NOVUM SOLUTIONS INC 1b869a1f-5787-4d03-a546-43a8217b2b2c 2025-04-07 Warnings Exact identifier application number: M017 MAG 5 PT ROLL-ON PAIN RELIEF COOLING MENTHOL RENU LABORATORIES, LLC 31e4fa2c-3a98-d618-e063-6394a90aec1c 2025-04-07 Warnings Exact identifier application number: M017 RockSauce FIERY HOT PAIN RELIEF METHYL SALICYLATE, MENTHOL, CAPSAICIN Implus Footcare, LLC cc7cbf4a-8274-e463-e053-2995a90a51e0 2025-04-07 Warnings Exact identifier application number: M017 RockSauce FIERY HOT PAIN RELIEF METHYL SALICYLATE, MENTHOL, CAPSAICIN Implus Footcare, LLC bdee018a-2c3c-3116-e053-2a95a90ac8d8 2025-04-07 Warnings Exact identifier application number: M017 RockSauce FIERY HOT PAIN RELIEF METHYL SALICYLATE, MENTHOL, CAPSAICIN Implus Footcare, LLC bdee2b65-2759-0e62-e053-2a95a90a0378 2025-04-07 Warnings Exact identifier application number: M017 RockSauce ICY COLD PAIN RELIEF MENTHOL Implus Footcare, LLC bdc7c7f3-ac98-8fe9-e053-2a95a90a2663 2025-04-07 Warnings Exact identifier application number: M017 RockSauce ICY COLD PAIN RELIEF MENTHOL Implus Footcare, LLC bd4fdff1-9174-31c2-e053-2a95a90a749f 2025-04-07 Warnings Exact identifier application number: M017 GREEN GUARD Topical Pain Relief LIDOCAINE HCI Ultra Distributors Inc b6f0041c-47fc-0bcd-e053-2a95a90ab1f9 2025-04-07 Warnings Exact identifier application number: M017 CBD Clinic Pain Relief - Level 5 MENTHOL, CAMPHOR ABACUS HEALTH PRODUCTS, INC. f0ebc1c6-93fb-efd6-e053-2995a90a25bb 2025-04-07 Warnings Exact identifier application number: M017 CBD Clinic Pain Relief - Level 4 MENTHOL, CAMPHOR ABACUS HEALTH PRODUCTS, INC. f0e9ac7c-a840-2e05-e053-2a95a90a33f1 2025-04-07 Warnings Exact identifier application number: M017 CBDMEDIC Active Sport Pain Relief CAMPHOR AND MENTHOL ABACUS HEALTH PRODUCTS, INC. f0ec5f47-2f8e-0558-e053-2a95a90aa7ca 2025-04-07 Warnings Exact identifier application number: M017 Hot Cold Medicated Patches HOT COLD MEDICATED PATCHES Henan Enokon Medical Instrument Co., Ltd. 159266a8-94fa-e2ff-e063-6394a90a9a77 2025-04-02 Warnings Exact identifier application number: M017 Pain Relief Patch PAIN RELIEF PATCH Henan Enokon Medical Instrument Co., Ltd. 1592d29d-e275-a44d-e063-6294a90ab17d 2025-04-02 Warnings Exact identifier application number: M017 Jointflex CAMPHOR Strides Consumer LLC 766b73f2-67bd-4d5c-805c-1057b3981ebf 2025-04-02 Warnings Exact identifier application number: M017 Olu Pain Management LIDOCAINE AND CAMPHOR Asclemed USA, Inc. d4d556c1-b64b-4b8e-8e4b-4f40eda24250 2025-04-01 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylate TROLAMINE SALICYLATE TELEBRANDS CORP 31ce185e-07b7-d837-e063-6394a90a1fb0 2025-04-01 Warnings Exact identifier application number: M017 CVS Pain Relief MENTHOL 10.5% CVS d0ea80ce-38b2-acde-e053-2995a90a47e5 2025-03-31 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE A2A Integrated Pharmaceuticals, LLC 31431866-6fb5-2acd-e063-6294a90ac520 2025-03-31 Warnings Exact identifier application number: M017 Citrus Cleansing Foot Soak and Body Soak CAMPHOR SANSAR, LLC f136616d-9f32-4e55-a495-b7466fd68526 2025-03-28 Warnings Exact identifier application number: M017 Zpol ULTRA MENTHOL, METHYL SALICYLATE Laboratorios Zepol S.A. 1a1433a6-8d04-96df-e063-6394a90a987b 2025-03-27 Warnings Exact identifier application number: M017
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