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 138 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Burn First Aid BURN FIRST AID Dynarex Corporation 826e08be-dffa-5a27-e053-2a91aa0a8701 2024-01-22 Warnings Exact identifier application number: M017 Target Up and Up Pain Relief Menthol Topical Analgesic Roll-On MENTHOL TARGET CORPORATION 0f95fc55-8665-9e89-e063-6394a90a7891 2024-01-22 Warnings Exact identifier application number: M017 CVS Health Lidocaine Pain Relief Plus Menthol LIDOCAINE, MENTHOL, UNSPECIFIED FORM Natural Essentials, Inc. 77978069-a1b4-473e-83c9-8320e00eea89 2024-01-19 Warnings Exact identifier application number: M017 ZIMS MAX FREEZE LEG CRAMPS CAMPHOR, MENTHOL KOBAYASHI Healthcare International, Inc. ba26635d-95d3-4d88-93cc-1fd4fd29fd79 2024-01-18 Warnings Exact identifier application number: M017 Burn LIDOCAINE HART Health e95ebdac-9789-41c2-97da-2307e4538794 2024-01-18 Warnings Exact identifier application number: M017 Medi-First Hydrocortisone 1% HYDROCORTISONE ACETATE Unifirst First Aid Corporation bd216f5d-f304-7d8d-e053-2a95a90aa9ce 2024-01-17 Warnings Exact identifier application number: M017 Green Guard Hydrocortisone 1% HYDROCORTISONE Unifirst First Aid Corporation bd348e2a-57b1-3f17-e053-2a95a90a8bdc 2024-01-17 Warnings Exact identifier application number: M017 Pain Relief LIDOCAINE, MENTHOL HUMN Pharmaceuticals Inc 6c96f94a-e724-eab3-e053-2991aa0aab88 2024-01-17 Warnings Exact identifier application number: M017 CVS Health Lidocaine Pain Relief LIDOCAINE Natural Essentials, Inc. 52e82e70-53b7-4ecb-be39-fe10c94cc444 2024-01-17 Warnings Exact identifier application number: M017 CVS Health XL Lidocaine Pain Relief LIDOCAINE NATURAL ESSENTIALS, INC. ec16da91-8244-402b-b8d8-84896094ac2c 2024-01-17 Warnings Exact identifier application number: M017 Anti-itch DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE Target Corporation f444b0a6-2ed3-4236-8206-342150290675 2024-01-17 Warnings Exact identifier application number: M017 Maximum Strength Hydrocortisone Anti-itch HYDROCORTISONE 1% Target Corporation 4ff39cb8-3a20-4fe7-9829-1e882a484668 2024-01-17 Warnings Exact identifier application number: M017 Salonpas Pain Relieving LIDOCAINE 4% FLEX LIDOCAINE Hisamitsu Pharmaceutical Co., Inc. 9507f727-c49f-4de4-9d64-b6d977d568ab 2024-01-17 Warnings Exact identifier application number: M017 Burn LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. eca272cb-ac8f-982b-e053-2995a90aa8b2 2024-01-15 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