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 124 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Wegmans Aloe After Sun Gel with Lidocaine HCl External AnalgesicLIDOCAINE HYDROCHLORIDEWEGMANS FOOD MARKETS INCf70bc438-7ed8-f74d-e053-6394a90a2b3f2024-10-16WarningsExact identifier
application number: M017
EQUATE Sunburn relief with Aloe After SunLIDOCAINEWal-Mart Stores Incc25e1288-7ac6-41fc-ab65-26c379f288a72024-10-16WarningsExact identifier
application number: M017
Genuine First Aid Insect Sting Relief Pad 1 ctBENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.b119ba37-0ee1-851a-e053-2995a90a85b12024-10-15WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINEWalgreen Company1a587e6e-88d1-4b01-abad-9a365dc64a4d2024-10-15WarningsExact identifier
application number: M017
TopCare Everyday After Sun CoolingLIDOCAINE HYDROCHLORIDETOPCO ASSOCIATES LLCbaff7293-e1a3-d1f2-e053-2995a90a93ca2024-10-15WarningsExact identifier
application number: M017
Universal PAIN RELIEFLIDOCAINEUniversal Distribution Center LLCb132a4f2-1b1f-4e80-a183-f9add449065f2024-10-14WarningsExact identifier
application number: M017
Nervex Pain RelievingCAPSAICINVITA SCIENCES, LLCa39bba22-8c54-4252-9973-052dd2aaea362024-10-14WarningsExact identifier
application number: M017
CVS Health Lidocaine Pain-RelievingLIDOCAINENATURAL ESSENTIALS, INC.d07fdffd-bf7c-4950-9b2d-c06d54ef4c552024-10-14WarningsExact identifier
application number: M017
Walgreens CoolingLIDOCAINE HYDROCHLORIDEWALGREEN COMPANYbaffb272-436c-4ad8-e053-2a95a90a56fb2024-10-14WarningsExact identifier
application number: M017
Walgreens Sunburn ReliefMENTHOLWALGREEN COMPANYc8967fba-6c28-494b-e053-2995a90acbba2024-10-14WarningsExact identifier
application number: M017
Walgreens Sunburn ReliefLIDOCAINEWALGREEN COMPANYd5067903-c559-dc6d-e053-2995a90a8ee32024-10-14WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEFMeijer Distribution Inc18998e1c-1254-4d0c-93f1-26652c5ca0762024-10-14WarningsExact identifier
application number: M017
signature care itch reliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATESafeway3eedcd9f-8312-4d14-a0fe-6b00a00d3e732024-10-13WarningsExact identifier
application number: M017
itch reliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEH E B34c7bcd3-203f-4630-894d-3739a1576c8d2024-10-13WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEH E B25ec9014-64c4-44df-9e67-9f9223ffc9232024-10-12WarningsExact identifier
application number: M017
PAIN RELIEF Gel-Roll OnLIDOCAINE AND MENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f02fa9c0-b8af-f362-e053-2a95a90ae5162024-10-11WarningsExact identifier
application number: M017
Insect Sting Relief PadBENZOCAINE, ALCOHOLHubei Changjian Medical Products Co., Ltd.6a269982-0e25-4c09-aef1-0b398bdc5ed42024-10-11WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEVIVE HEALTH LLC24221805-e5c9-5785-e063-6394a90a9d2f2024-10-10WarningsExact identifier
application number: M017
De La Cruz CamphorCAMPHORDLC Laboratories, Inc.62359237-de2d-4497-bfd6-36991cfc8acf2024-10-10WarningsExact identifier
application number: M017
Anti ItchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEMeijer Distribution Inc4f536a86-6419-4ab0-a7e8-5c37943823e22024-10-09WarningsExact 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