CeraVe Developed with Dermatologists Itch Relief Moisturizing

Product NDC
82046-620
11-digit product format
820460620
Labeler code
82046
Product ID
82046-620_53ff6a6c-255b-b052-e063-6394a90ac688
Type
HUMAN OTC DRUG
Nonproprietary name
pramoxine hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-19
Substance
PRAMOXINE HYDROCHLORIDE
Active strength
10 mg/g
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 HYDROCHLORIDE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1052684Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7c78d980-fc94-498c-aec5-464c0c76c8f4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
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
82046-620-01CeraVe Developed with Dermatologists Itch Relief Moisturizing340 g in 1 JARCREAM3401
82046-620-02CeraVe Developed with Dermatologists Itch Relief Moisturizing453 g in 1 JARCREAM4531

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 112 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChiggerexBENZOCAINERANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH5e5d84ab-f57f-448d-a4c1-ced38890eec22024-12-17WarningsExact identifier
application number: M017
DerMend Moisturizing Anti-ItchPRAMOXINE HYDROCHLORIDEFerndale Laboratories, Inc.14c7fb1c-a310-4b12-ab2e-7f1c0801995c2024-12-17WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEGeri-Care Pharmaceuticals, Corpfd67566a-1076-019d-e053-6394a90a415c2024-12-17WarningsExact identifier
application number: M017
Extra StrengthMENTHOL AND METHYL SALICYLATENATURES FORMULAE HEALTH PRODUCTS LTD.d919b50a-5de2-1830-e053-2a95a90ab88d2024-12-17WarningsExact identifier
application number: M017
Cold and Heat Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLWalgreen Company1f262473-3f3c-4f3f-b507-590d06ff69a92024-12-17WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEWalgreen Companydb8cf218-7544-4871-b1c3-a50a3d3e59f12024-12-17WarningsExact identifier
application number: M017
Albertsons Pain Relief PatchLIDOCAINESafewaydc2823bb-8586-daca-e053-2995a90a2af02024-12-17WarningsExact identifier
application number: M017
CAPSAICIN HEAT PATCHES BACK AND LARGE AREASCAPSAICINWalgreen Companye77167ab-6cb8-4d5b-838c-b0acc05e38892024-12-17WarningsExact identifier
application number: M017
Hot and Cold Medicated PatchMENTHOLWalgreen Companyd9fc133d-ebaa-48f1-a6f9-62453970012b2024-12-17WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINEWalgreen Company204b96bc-af4e-4842-8b57-7b416feb4dd92024-12-17WarningsExact identifier
application number: M017
Lidocaine DryLIDOCAINECVSbb7955fe-5113-1662-e053-2a95a90a85a12024-12-16WarningsExact identifier
application number: M017
HealthWise Medicated Original Body Powder 10 ozMENTHOLVeridian Healthcare296b623a-14cd-0bca-e063-6394a90ac5ff2024-12-16WarningsExact identifier
application number: M017
HealthWise Medicated Extra Body Powder 10 ozMENTHOLVeridian Healthcare296c9a9c-e3db-59fe-e063-6294a90a0b622024-12-16WarningsExact identifier
application number: M017
Rite Aid Hot and Cold Roll OnMENTHOL 16%Rite Aidfc4b2635-280b-267f-e053-6294a90a5e222024-12-15WarningsExact identifier
application number: M017
Rite Aid Pain RelievingBENZOCAINE 20%, MENTHOL 0.5%Rite Aide2c09e85-be0a-4e6d-e053-2995a90ad7562024-12-15WarningsExact identifier
application number: M017
Rugby LidocaineLIDOCAINE 4%Rugby Laboratoriesd94292f7-10fc-48bf-e053-2995a90a84722024-12-15WarningsExact identifier
application number: M017
Rite Aid CortisoneHYDROCORTISONE 1%Rite Aide27353b9-23b6-3801-e053-2a95a90a60452024-12-15WarningsExact identifier
application number: M017
Rite Aid Cooling Pain ReliefMENTHOL 10.5%Rite Aide2225259-70ec-52de-e053-2a95a90a73f82024-12-15WarningsExact identifier
application number: M017
Rite Aid Rectal CareLIDOCAINE 5%Rite Aide283e462-96e8-04cf-e053-2a95a90a1d002024-12-15WarningsExact identifier
application number: M017
Rite Aid Anti-ItchDIPHENHYDRAMINE HCL 2%Rite Aide33898d8-1b8b-5c0b-e053-2995a90add082024-12-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052684pramoxine HCl 1 % Topical CreamPSN7c78d980-fc94-498c-aec5-464c0c76c8f41
1052684pramoxine hydrochloride 10 MG/ML Topical CreamSCD7c78d980-fc94-498c-aec5-464c0c76c8f41
1052684pramoxine hydrochloride 1 % Topical CreamSY7c78d980-fc94-498c-aec5-464c0c76c8f41

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052684pramoxine HCl 1 % Topical CreamPSN7c78d980-fc94-498c-aec5-464c0c76c8f41
1052684pramoxine hydrochloride 10 MG/ML Topical CreamSCD7c78d980-fc94-498c-aec5-464c0c76c8f41
1052684pramoxine hydrochloride 1 % Topical CreamSY7c78d980-fc94-498c-aec5-464c0c76c8f41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82046-620-0182046062001340 g in 1 JAR (82046-620-01) 340 g2026-05-19NoNoCurrent
82046-620-0282046062002453 g in 1 JAR (82046-620-02) 453 g2026-05-19NoNoCurrent
82046-620-0382046062003539 g in 1 JAR (82046-620-03) 539 g2026-06-11NoNoCurrent