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 123 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZYLOTROL PAIN RELIEVINGLIDOCAINE HCL, MENTHOLAsclemed USA, Inc.1553351c-aee8-4c40-9548-35cce246bda92024-10-25WarningsExact identifier
application number: M017
OutgroBENZOCAINEMedtech Products Inc.d6be8a1d-aca7-42b1-86da-881d42ffe8d52024-10-25WarningsExact identifier
application number: M017
Monistat Complete Care Instant Itch ReliefHYDROCORTISONEInsight Pharmaceuticals LLCa0f40504-6183-4f32-8d17-6586b3f386a62024-10-25WarningsExact identifier
application number: M017
Boil EaseBENZOCAINEInsight Pharmaceuticals LLCbf108934-5e1a-4059-9dcf-008f52a83fab2024-10-25WarningsExact identifier
application number: M017
Dermarest Eczema MedicatedHYDROCORTISONEInsight Pharmaceuticals LLC0292ab62-5088-45fa-a056-70c2fcc19ef72024-10-25WarningsExact identifier
application number: M017
anti itchHYDROCORTISONEMeijer, Inc.2db7bcab-acb8-48ad-8cd1-842ff7765ed92024-10-23WarningsExact identifier
application number: M017
NATUREANCE MIRACLEMENTHOLEROS GLOBAL CORPec1a2a1f-a38d-9c59-e053-2a95a90ad2682024-10-23WarningsExact identifier
application number: M017
Profoot Plantar Relief StripsCAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATERooftop Consumer Health, Inc.65e142d8-da21-4c55-9faf-b387cb6c2c0e2024-10-23WarningsExact identifier
application number: M017
Profoot Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATERooftop Consumer Health, Inc.cc011b79-2761-40f7-8142-88f8e30a179a2024-10-23WarningsExact identifier
application number: M017
Profoot Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEProfoot, Inc.06f82bde-41a1-35f6-e063-6394a90a64372024-10-23WarningsExact identifier
application number: M017
Deep Cover Bug Bite ReliefBENZOCAINEMorrisons Outdoors, LLC25010dd6-fb48-8ee7-e063-6394a90aee6c2024-10-21WarningsExact identifier
application number: M017
Evel Knievels Natural Choice Pain ReliefMENTHOL, UNSPECIFIED FORMNatural Essentials, Inc.4576656c-4b6e-6965-7665-6c52756c65732024-10-21WarningsExact identifier
application number: M017
berkley and jensen anti itchHYDROCORTISONEBJWC5cc6e4f6-c62d-4923-9726-9dbc569a3f492024-10-19WarningsExact identifier
application number: M017
DG Health Hydrocortisone Maximum StrengthHYDROCORTISONEDolgencorp Inc2cc792b8-dce6-4178-bd6d-63ba268b77472024-10-19WarningsExact identifier
application number: M017
Careland Hydrogel Pain Relief PatchesLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.e970070c-1c3b-49f0-8298-e6c5ebbf50a02024-10-18WarningsExact identifier
application number: M017
Fruit of the Earth Cool Blue Aloe Mist ContinuousLIDOCAINE HYDROCHLORIDEFruit Of The Earth, Inc.d4caae4c-efba-2453-e053-2995a90a5e5f2024-10-18WarningsExact identifier
application number: M017
CVS Health Sunburn Relief Cooling Lidocaine 0.5 Pain-RelievingLIDOCAINE HCLCVS Pharmacyf0f1969d-10e0-76ee-e053-2995a90a73362024-10-17WarningsExact identifier
application number: M017
Wong To Yick External AnalgesicCAMPHOR MENTHOL METHYL SALICYLATEWong To Yick Wood Lock Ointment Ltd16a21af4-6bc0-4ae1-aa3b-1da84c8286e22024-10-17WarningsExact identifier
application number: M017
Wong To Yick External AnalgesicCAMPHOR MENTHOL METHYL SALICYLATEWicsun Trading Inc0b4bd444-b3c1-47aa-a7e3-f16c923261242024-10-17WarningsExact identifier
application number: M017
Fruit of the Earth Sun Town City Aloe Vera After Sun with Lidocaine HCLLIDOCAINEFruit of the Earth, Inc.c7a833bd-7457-73a3-e053-2a95a90ac53f2024-10-17WarningsExact 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