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 117 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Flexible Pain Relieving LidocaineLIDOCAINE, MENTHOLWalgreen Co.6f070fa3-a61a-4523-a470-ab58bf9400a32024-11-27WarningsExact identifier
application number: M017
Benadryl Original Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLC920c50cb-9bdd-4a36-bb3d-c2559db733272024-11-26WarningsExact identifier
application number: M017
Universal ARTHRITIS and SPORTMETHYL SALICYLATE, CAPSICUMUniversal Distribution Center LLC884907a8-c884-4cce-ac10-9d4848fdba3e2024-11-22WarningsExact identifier
application number: M017
Universal ARTHRITIS and SPORTMETHYL SALICYLATE, CAPSICUMUniversal Distribution Center LLC7f067e95-e01c-4b9a-a02e-0af097beb18c2024-11-22WarningsExact identifier
application number: M017
Universal ARTHRITIS and SPORTMETHYL SALICYLATE, CAPSICUMUniversal Distribution Center LLC9ece9b3a-0092-4c1c-a913-c2fefcd705412024-11-22WarningsExact identifier
application number: M017
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd1936c5f4-274b-8e49-e063-6394a90ac6422024-11-21WarningsExact identifier
application number: M017
Hempvana Ultra Strength Pain Relief Cream Platinum 4% LidocaineLIDOCAINE 4%Telebrands Corp2788189e-35bc-d48c-e063-6294a90ae6c22024-11-21WarningsExact identifier
application number: M017
Family Wellness Ultra Strength Muscle RubULTRA STRENGTH MUSCLE RUBFAMILY DOLLAR (Family Wellness)554c7d3c-09f4-4923-b4ca-d5de8f7e2c9a2024-11-21WarningsExact identifier
application number: M017
Family Wellness Anorectal LidocaineANORECTAL LIDOCAINEFAMILY DOLLAR (Family Wellness)ed7e0cdc-ca4b-47ba-b82b-49fb4913ef8d2024-11-21WarningsExact identifier
application number: M017
Family Wellness Hot and Cold Pain ReliefHOT AND COLD PAIN RELIEFFAMILY DOLLAR (Family Wellness)b70e343b-18aa-4e45-ae8e-79d8c84ad2052024-11-21WarningsExact identifier
application number: M017
Signature Care Lidocaine CreamLIDOCAINEBetter Living Brands LLC5483729e-ef1a-47a2-b7cf-c19744f520732024-11-21WarningsExact identifier
application number: M017
WINCO HydrocortisoneHYDROCORTISONE 1%WinCo Foods LLC26a29de3-4b79-4a3a-93b6-a14c5e91a8c62024-11-21WarningsExact identifier
application number: M017
Menthol and Zinc OxideMENTHOL AND ZINC OXIDEDynarex Corporationd0e43651-4215-465b-9ace-1bc23126b1092024-11-20WarningsExact identifier
application number: M017
Hempvana Cold As Ice Pain Relief Gel-PatchMENTHOLTelebrands Corp976a1bb2-b776-8199-e053-2995a90a1a1b2024-11-20WarningsExact identifier
application number: M017
Hempvana Maximum Strength Pain ReliefTROLAMINE SALICYLATETELEBRANDS CORPd91a0fad-a38c-1580-e053-2a95a90ad2682024-11-20WarningsExact identifier
application number: M017
Hempvana Maximum Strength Pain Relief - PlatinumTROLAMINE SALICYLATETELEBRANDS CORPd58da6c5-47a6-b8a8-e053-2995a90a7ce72024-11-20WarningsExact identifier
application number: M017
Hempvana Knee Bird Ultra Strength Pain ReliefLIDOCAINE, MENTHOLTELEBRANDS CORPdf5d3312-cbc5-5db9-e053-2995a90ab0552024-11-20WarningsExact identifier
application number: M017
Hempvana Cold as Ice GelMENTHOLTelebrands Corpa9e103f2-778f-e49b-e053-2a95a90aa8b72024-11-20WarningsExact identifier
application number: M017
Hempvana Knee Bird Ultra Strength Pain ReliefLIDOCAINE, MENTHOLTELEBRANDS CORPd58e2c47-c0f4-625e-e053-2a95a90aa4d52024-11-20WarningsExact identifier
application number: M017
Hempvana Pain ReliefTROLAMINE SALICYLATETelebrands Corp92a29553-a102-0a0e-e053-2a95a90ab24a2024-11-20WarningsExact 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