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 146 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NATURES CRAFT LIDOCAINE Male Genital Desensitizer LIDOCAINE HYDROCHLORIDE Natures Design Products LLC 61bf1776-5c6c-4307-8348-41fa60164017 2023-11-11 Warnings Exact identifier application number: M017 CLEAN REMEDIES CR PAIN RELIEF MENTHOL Clean Remedies, LLC aea9291d-3244-401c-9607-e91107228faa 2023-11-11 Warnings Exact identifier application number: M017 Arth Arrest METHYL NICOTINATE, CAPSAICIN Key 2 Health, Inc. 495034ac-dbf5-4c55-906b-6ffcbcfd5bc2 2023-11-11 Warnings Exact identifier application number: M017 KINETIC ICE Muscle and Joint Pain Relief Cream MENTHOL No Reason, LLC 565f0e20-e534-41db-ba20-e726d578405f 2023-11-11 Warnings Exact identifier application number: M017 KARMA RUB Elemental Pain Relief LIDOCAINE HYDROCHLORIDE Elemental Bliss LLC c224fb1b-827f-461e-a58f-4020700c3e0d 2023-11-11 Warnings Exact identifier application number: M017 Bakers Best Arthritis Pain Relief with Hemp Seed HISTAMINE DIHYDROCHLORIDE Baker's Best Health Products, LLC 46415d28-99b5-4c9e-bde9-1c703595f671 2023-11-11 Warnings Exact identifier application number: M017 Dr PAINES Pain Relief MENTHOL DOCTOR PAINE'S MEDICAL, LLC 79d2b332-051e-48c1-afe8-6d4468cd1878 2023-11-11 Warnings Exact identifier application number: M017 INTIMALE Maximum Strength Delay LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 25b9ade3-72b0-4b86-8c48-90310a26806f 2023-11-11 Warnings Exact identifier application number: M017 POWERECT Max Power Male Delay LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 25a1c926-9543-44a7-865e-a4b6e1a40cbe 2023-11-11 Warnings Exact identifier application number: M017 SKINS DELAY Maximum Strength Lidocaine LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 172efe5d-28b8-443c-b3f9-429669189081 2023-11-11 Warnings Exact identifier application number: M017 GASPARI Ageless Pain Relief Cream MENTHOL GASPARI ANTI-AGING LLC ea806089-688b-4944-ad69-86f366509eb5 2023-11-11 Warnings Exact identifier application number: M017 ZENSEZONE Arthmed Temporary Pain Relief Cream CAPSAICIN, MENTHOL, METHYL SALICYLATE ZENSEZONE LLC c5778f22-c411-4bd7-b2af-45e3fee15fd2 2023-11-11 Warnings Exact identifier application number: M017 PRFC HEMP Topical Analgesic MENTHOL DOBEST INC 722da9d1-91d7-45be-adb1-8d6a22aa83ac 2023-11-11 Warnings Exact identifier application number: M017 AMP RELIEF Pain Relief Cream MENTHOL COASTAL FORMULAS LLC 84ea496e-ab54-4882-93ef-600f8eb33cb4 2023-11-11 Warnings Exact identifier application number: M017 AMP RELIEF Pain Relief Cream MENTHOL COASTAL FORMULAS LLC 39564c67-49ab-42d4-a391-792ac69180c0 2023-11-11 Warnings Exact identifier application number: M017 LIDOSOLVE PAIN RELIEF LIDOCAINE HYDROCHLORIDE HENNIKA HEALTH, LLC 3a9e4e0c-362d-4e66-bb5f-984fe1c9d4e2 2023-11-11 Warnings Exact identifier application number: M017 AMINO ACTIVE Topical Analgesic Cream HISTAMINE DIHYDROCHLORIDE VIREO SYSTEMS, INC. 591b1e7e-a8c0-4640-a592-4e0f3538a40e 2023-11-11 Warnings Exact identifier application number: M017 NERVE ACTIVE Pain Relief Cream MENTHOL TOP DOG DIRECT, LLC a8b85dcb-fd3e-4340-a945-609fc741443c 2023-11-11 Warnings Exact identifier application number: M017 GeriGentle FrostyHeat Pain Relief Patch 4 Lodocaine Back LIDOCAINE Geri-Gentle Corporation e4427928-c063-9ca6-e053-2995a90a1aa1 2023-11-10 Warnings Exact identifier application number: M017 GeriGentle FrostyHeat Pain Relief Patch Arm and Neck MENTHOL Geri-Gentle Corporation e4429f70-667e-662b-e053-2a95a90a62ba 2023-11-10 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