FDA.reportPublic FDA data

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 132 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Genuine First Aid Alcohol Cleansing PadBENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.c39c4d80-9718-459f-8ae4-ada043bba5b72024-06-26WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll OnMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA1bd5cf69-9a08-5e2e-e063-6394a90a03cd2024-06-26WarningsExact identifier
application number: M017
Solarcaine Burn Pain Relief 4ozSOLARCAINE BURN PAIN RELIEF 4OZWellSpring Pharmaceutical Corporation2c0389db-ceb2-422b-9575-bdb8fe649a1e2024-06-26WarningsExact identifier
application number: M017
astoneaHYDROCORTISONEASTONEA LABS PRIVATE LIMITEDde09e859-c5fd-0cc5-e053-2a95a90a147e2024-06-25WarningsExact identifier
application number: M017
HealthWise Pain Relief Lidocaine PatchLIDOCAINE 4%Veridian Healthcare0190196d-5f78-042b-e063-6294a90a37142024-06-25WarningsExact identifier
application number: M017
Eagle Brand Medicated OilMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA1bc1bf83-91ee-ec9d-e063-6394a90a3daf2024-06-25WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll OnMENTHOL, METHYL SALICYLATEBorden Company (Private) Limited1bc2f688-d0c4-690e-e063-6294a90abc382024-06-25WarningsExact identifier
application number: M017
Eagle Brand Medicated OilMENTHOL, METHYL SALICYLATEBorden Company (Private) Limited1b9fdac0-9fb0-e669-e063-6394a90aece92024-06-24WarningsExact identifier
application number: M017
CapsaicinCAPSAICINAsclemed USA, Inc.97d506bd-3215-4e2e-9914-af1c174dd4ab2024-06-20WarningsExact identifier
application number: M017
ABREVA Rapid Pain ReliefGLYCERIN, LIDOCAINEHaleon US Holdings LLC65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d2024-06-20WarningsExact identifier
application number: M017
Frankie Avalons ZERO PAIN Roll-On Pain RelieverCAPSAICINWHY ENTERPRISES LLCe32acb5f-5bc3-4228-b037-6315d080f5562024-06-17WarningsExact identifier
application number: M017
PUREGEN LABS Pain Relief 4 LidocaineLIDOCAINEAdvanced Rx LLC9dff40d8-8d7e-4629-bea5-987f5e68477d2024-06-11WarningsExact identifier
application number: M017
SMOOTH GATOR Head-Ezz AnalgesicMENTHOLSmooth Gator LLC02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd2024-06-10WarningsExact identifier
application number: M017
FIRST AID BURNLIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDEEpic Medical Supply Corpbd1b1873-e900-45eb-96a0-28f782b5a7cd2024-06-04WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEChain Drug Marketing Association Inc.1c834ba0-86b6-8e61-e063-6394a90a192d2024-06-04WarningsExact identifier
application number: M017
HealthWise Feminine Anti-itch CreamBENZOCAINE, RESORCINOLVeridian Healthcare19fe7c3b-58e2-6c16-e063-6394a90a612a2024-06-03WarningsExact identifier
application number: M017
THE SOLUTION NUMBINGLIDOCAINE HYDROCHLORIDESCALP TECH INC184be4cc-b0b9-7882-e063-6394a90a8e7e2024-05-25WarningsExact identifier
application number: M017
Methyl Salicylate 25 PercentMETHYL SALICYLATEAlexso, Incd8b8b0ba-69e9-4965-bf9b-6db21db69b342024-05-23WarningsExact identifier
application number: M017
Meijer Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILMeijer Distribution07ecc6a7-bbe3-35cf-e063-6394a90a21802024-05-22WarningsExact identifier
application number: M017
TheraCare Hydrocortisone CreamHYDROCORTISONEVeridian Healthcare01cb7b47-2c3c-707d-e063-6294a90a5d972024-05-21WarningsExact 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