FDA.reportPublic FDA data

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 43 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BLT 2LIDOCAINE HCLCENTURA PHARMACEUTICALS INC41dc85ec-d79b-0a32-e054-00144ff8d46c2026-01-12WarningsExact identifier
application number: M017
Mineral Ice Pain RelievingMENTHOLCrown Laboratories7b30076a-0af6-2f74-e053-2a91aa0ae08d2026-01-12WarningsExact identifier
application number: M017
SarnaPRAMOXINE HYDROCHLORIDECrown Laboratories19b0ce1b-e147-01a1-e063-6394a90af8082026-01-12WarningsExact identifier
application number: M017
SarnaPRAMOXINE HYDROCHLORIDE, MENTHOLCrown Laboratories, Inc19c41e75-a654-90cf-e063-6394a90a7e972026-01-12WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEHY-VEE, INC48350b54-8d9a-48c4-e063-6394a90ac0402026-01-12WarningsExact identifier
application number: M017
LidoPlus Pain ReliefLIDOCAINE HYDROCHLORIDECentura Pharmaceuticals, Inc07bacc6c-60a6-4297-8663-904a22bdc0402026-01-12WarningsExact identifier
application number: M017
BlueStop MaxEXTERNAL ANALGESICClavel Corporationf1efb51c-5217-4cb2-e053-2a95a90a7f952026-01-12WarningsExact identifier
application number: M017
BlueStop MaxEXTERNAL ANALGESICClavel Corporationf2277e27-868b-57ef-e053-2a95a90abf282026-01-12WarningsExact identifier
application number: M017
BLT 3TETRACAINECENTURA PHARMACEUTICALS INC401a0d22-1181-02ac-e054-00144ff88e882026-01-12WarningsExact identifier
application number: M017
Sting Relief Prep PadBENZOCAINENINGBO TIANBO FIRST AID PRODUCT CO., LTD.0c901f64-6890-45c0-9ca7-ee9de87903c42026-01-12WarningsExact identifier
application number: M017
Goodsense Oral Pain ReliefBENZOCAINEGeiss, Destin and Dunn, Inc.eb461b70-d10f-4e11-8374-e43713f3504d2026-01-12WarningsExact identifier
application number: M017
Extra Strength BalmCAPSICUM AND MENTHOLSaje Natural Business Incf516e416-446b-8f21-e053-2a95a90afd882026-01-12WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.3df0e56a-7651-42dc-8ed8-f68836a63c612026-01-12WarningsExact identifier
application number: M017
Trauma LessMENTHOLSaje Natural Business Inc.650cba4c-6aba-48c3-9c41-841f199055482026-01-12WarningsExact identifier
application number: M017
MamisanLIDOCAINE HYDROCHLORIDE, MENTHOLMiramar Cosmetics, Inc DBA Miramar Lab4402e900-c6e9-4f32-8cc4-c84014384a9f2026-01-12WarningsExact identifier
application number: M017
Curist Lidocaine PatchLIDOCAINE 4% PATCHLittle Pharma, Inc.1a8fe44e-7a21-c2ab-e063-6394a90a61002026-01-11WarningsExact identifier
application number: M017
DG Health Pain RelievingLIDOCAINE HCLDOLGENCORP, LLC923aeb4c-049f-4ecc-a77e-9ffa0e236d4e2026-01-11WarningsExact identifier
application number: M017
Campho-Phenique AntisepticCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare46b84e0b-78a9-4cde-9f90-e165b54191622026-01-09WarningsExact identifier
application number: M017
MyDerm Pro Freeze Cooling Menthol Pain Relief Roll-OnMENTHOLInspec Solutions12ff9b9a-73e5-ce31-e063-6294a90aeaf82026-01-09WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.bb0278c9-eaff-d435-e053-2995a90a202a2026-01-09WarningsExact 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