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
IngredientStrength
PRAMOXINE HYDROCHLORIDE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88AYB867L5Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
13ce57d0-b1c5-4685-ad7d-a562d9d8fc86Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-970-01CeraVe Developed with Dermatologists Itch Relief Moisturizing237 mL in 1 BOTTLE, PUMPLOTION2379
49967-970-02CeraVe Developed with Dermatologists Itch Relief Moisturizing15 in 1 TRAYLOTION159
49967-970-02CeraVe Developed with Dermatologists Itch Relief Moisturizing29.6 mL in 1 BOTTLELOTION29.69
49967-970-03CeraVe Developed with Dermatologists Itch Relief Moisturizing473 mL in 1 BOTTLELOTION4739
49967-970-04CeraVe Developed with Dermatologists Itch Relief Moisturizing562 mL in 1 BOTTLELOTION5629

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49967-970-01ML - Milliliter49967-970b98df13a-1797-40e8-b0d2-71f8aa29744c12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-970CERAVE DEVELOPED WITH DERMATOLOGISTS ITCH RELIEF MOISTURIZING (PRAMOXINE HYDROCHLORIDE) LOTION [L'OREAL USA PRODUCTS INC]8Current NDC, Legacy NDC, 5 package rows20240101_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 78 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Asper FlexLIDOCAINEAkron Pharma Inc.06ddae64-cda7-4eb9-872f-5182c83cb00c2025-09-19WarningsExact identifier
application number: M017
Good Neighbor Pain Relief Patch With Lidocaine 4%LIDOCAINEAmerisource Bergen5f5cc887-d479-4c9a-affc-49d0c331f7422025-09-18WarningsExact identifier
application number: M017
TheraCare Roll-on Lidocaine Pain Relief LiquidLIDOCAINE HCIVeridian Healthcaree942d447-754d-4683-9c99-57c7e83d7ea82025-09-18WarningsExact identifier
application number: M017
TheraCare Roll-on Lidocaine Pain Relief Liquid - LavenderLIDOCAINE HCIVeridian Healthcare6bebce76-30f6-4070-b0fe-58246d0713282025-09-18WarningsExact identifier
application number: M017
HealthWise Roll-On Lidocaine Pain Relief LiquidLIDOCAINE HCIVeridian Healthcare1133f6d4-f4c0-4ce9-e063-6394a90a5f4e2025-09-18WarningsExact identifier
application number: M017
InkKulture NumbingLIDOCAINE HCLProdigy Media Inc85a64315-dfa5-4f23-9f61-1cce694ea6bd2025-09-17WarningsExact identifier
application number: M017
Ink Scribd NumbingLIDOCAINE HCLProdigy Media Inc54173858-aff0-43b2-bc7b-c4ecab9bc3e52025-09-17WarningsExact identifier
application number: M017
Inkorporated NumbingLIDOCAINE HCLProdigy Media Inc3017056c-f3c6-4300-8344-bf6e7d32e8702025-09-17WarningsExact identifier
application number: M017
TattooGirl NumbingLIDOCAINE HCLProdigy Media Inc6abe4540-f6c9-412a-83f3-682df77150572025-09-17WarningsExact identifier
application number: M017
Dr Tatty NumbingLIDOCAINE HCLProdigy Media Inc5bb558c1-bf8f-4956-8732-e19720f62f312025-09-17WarningsExact identifier
application number: M017
Burn Ease CoolingLIDOCAINEProStat First Aid LLCec201ca1-efa0-4797-aec3-115647c29abd2025-09-17WarningsExact identifier
application number: M017
MedFreeze Naturally Cool Pain ReliefMENTHOLMEDKO LLC240f2346-c585-4334-997c-45db6268d7c42025-09-15WarningsExact identifier
application number: M017
MEDISTIK DUAL HOT AND COLDMETHYL SALICYLATE, MENTHOLNatureteq Inc.ba5f4626-f077-4a28-8dcc-dacd50741ead2025-09-15WarningsExact identifier
application number: M017
MEDISTIK ICEMENTHOL, CAMPHORNatureteq Inc.c1077744-7b9a-4536-8faf-e21994a43ea52025-09-15WarningsExact identifier
application number: M017
Caring Mills Vaginal Anti-Itch CreamBENZOCAINE, RESORCINOLVeridian Healthcarecd379e74-2841-47e4-b95a-de1b341b397f2025-09-15WarningsExact identifier
application number: M017
Lidocaine-Pain-Relief-PatchLIDOCAINE-PAIN-RELIEF-PATCHHenan Enokon Medical Instrument Co., Ltd.3ecfa867-50f6-d98a-e063-6394a90aefa02025-09-14WarningsExact identifier
application number: M017
Meijer Hydrocortsione CreamHYDROCORTSIONE CREAM 1%Meijer Distribution Inc.1cbddb7e-f2e3-0951-e063-6394a90a3d372025-09-12WarningsExact identifier
application number: M017
JO Prolonger with BenzocaineBENZOCAINECC Wellness LLCd955f612-1267-f1be-e053-2995a90a53452025-09-12WarningsExact identifier
application number: M017
JO for Him Prolonger with LidocaineLIDOCAINECC Wellness LLCb12dc6a3-142d-3219-e053-2995a90aead02025-09-12WarningsExact identifier
application number: M017
Walgreens Medicated Foot PowderMENTHOLDavion, Inc58e1e7f7-6284-411f-9765-0e63eabca0f32025-09-12WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-970-0149967097001237 mL in 1 BOTTLE, PUMP (49967-970-01) 237 ml2017-08-170000-00-00NoNoCurrent
49967-970-024996709700215 BOTTLE in 1 TRAY (49967-970-02) / 29.6 mL in 1 BOTTLE15 bottle2017-08-170000-00-00NoNoCurrent
49967-970-0349967097003473 mL in 1 BOTTLE (49967-970-03) 473 ml2017-08-170000-00-00NoNoCurrent
49967-970-0449967097004562 mL in 1 BOTTLE (49967-970-04) 562 ml2017-08-170000-00-00NoNoCurrent