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 122 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sanar Naturals Arnica ReforzadaCAMPHORSanvall Enterprises, Inc1921a4b1-cd36-195e-e063-6294a90a87932024-10-31WarningsExact identifier
application number: M017
Sanar Naturals Arnica Pain Releiving Roll On with CamphorCAMPHORSanvall Enterprises, Inc173db0e2-611f-55b9-e063-6394a90ac9872024-10-31WarningsExact identifier
application number: M017
Sanar Naturals CamphorCAMPHORSanvall Enterprises, Inc1921e851-cf83-0bdb-e063-6294a90a357f2024-10-31WarningsExact identifier
application number: M017
cortisoneHYDROCORTISONECVS Pharmacyc766deac-d993-4e48-a5c3-4cfde7338dff2024-10-31WarningsExact identifier
application number: M017
Walgreens Pain Relieving with Lavender AnalgesicLIDOCAINE HYDROCHLORIDEWalgreen Company6c7b39c8-5b65-430a-a529-5b6b14adce182024-10-31WarningsExact identifier
application number: M017
Walgreens Pain Relieving Plus Turmeric AnalgesicTROLAMINE SALICYLATEWalgreen Companyf3a121bc-7572-49a4-9822-2b6d858c19d22024-10-31WarningsExact identifier
application number: M017
dg health hydrocortisoneHYDROCORTISONEDolgencorp, LLC27dc9e09-fc4f-4b66-a303-177725f3a5132024-10-31WarningsExact identifier
application number: M017
basic care hydrocortisoneHYDROCORTISONEAmazon.com Services LLCf5419859-3f9f-43ff-9a3f-6aa81af044f02024-10-31WarningsExact identifier
application number: M017
ARCTIC RELIEFMENTHOL, UNSPECIFIED FORMSTRATUS PHARMACEUTICALS INCd27fbc17-46b7-4d52-ba29-c99b6c63144a2024-10-31WarningsExact identifier
application number: M017
Pain Relief Gel-PatchLIDOCAINE, MENTHOLR & Y Group, LLCfe0478d8-2f06-cd56-e053-6294a90a58e52024-10-30WarningsExact identifier
application number: M017
JOINT-RITIS PAIN RELIEVING ROLL-ONMENTHOLLifeline Naturals of America, Inc.ec5d99c4-6bba-45d1-84e0-12fb7cb314952024-10-30WarningsExact identifier
application number: M017
Walgreens Pain Relieving with Turmeric AnalgesicLIDOCAINE HYDROCHLORIDEWalgreen Company317ec4fb-cff0-461d-9ca0-299527a3686d2024-10-30WarningsExact identifier
application number: M017
Walgreens Pain Relieving AnalgesicCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATEWalgreen Company3215a676-104c-43c3-aa36-b30d5b67799a2024-10-30WarningsExact identifier
application number: M017
Ultra-Strength Pain Relief AnalgesicCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMTARGET CORPORATION159c5a84-bf68-41dd-a2d3-bc24020372442024-10-30WarningsExact identifier
application number: M017
DG Health Cold n Hot Pain Relieving Topical AnalgesicMENTHOL, UNSPECIFIED FORMDolgencorp Inc8fe13b85-ab74-42f8-a664-d3d2959921ac2024-10-30WarningsExact identifier
application number: M017
DEBACHERE Butt Balm After Care Antiseptic Pain ReliefBENZOCAINE, BENZALKONIUM CHLORIDEDE.BACHERE USA LLC8ba42864-69bf-455c-98d4-7f4ff94edceb2024-10-29WarningsExact identifier
application number: M017
Signature Care HydrocortisoneHYDROCORTISONESafewaybeefab66-b056-4bf1-b047-0780704ab87e2024-10-29WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEH E B15eb4676-5f6e-4c28-b5b9-4e45412dc37a2024-10-29WarningsExact identifier
application number: M017
Rael PAIN RELIEF ROLL-ON AnalgesicCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMRael, Inc.e6c49606-7c13-4dc6-a22d-ba54173ba7882024-10-28WarningsExact identifier
application number: M017
Monistat Care Instant Itch ReliefBENZOCAINEInsight Pharmaceuticals LLC4e9dc791-419f-4c79-aed4-760f8c17a5dd2024-10-25WarningsExact 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