FDA.reportPublic FDA data

CeraVe Developed with Dermatologists Healing Lip Balm

Product NDC
82046-483
11-digit product format
820460483
Labeler code
82046
Product ID
82046-483_523fd16e-da76-e6ff-e063-6394a90abded
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
CREAM
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-20
Substance
PETROLATUM
Active strength
495 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 Healing Lip Balm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM495 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4T6H12BN9UInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
21dc8842-0672-4d46-bcea-b8e3d54c48bfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82046-483-01CeraVe Developed with Dermatologists Healing Lip Balm9 g in 1 TUBECREAM92
82046-483-01CeraVe Developed with Dermatologists Healing Lip Balm1 in 1 CARTONCREAM12
82046-483-02CeraVe Developed with Dermatologists Healing Lip Balm2 in 1 CARTONCREAM22
82046-483-02CeraVe Developed with Dermatologists Healing Lip Balm9 g in 1 TUBECREAM92

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 59 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vitamin A and DVITAMIN A AND DMIDWOOD BRANDS, LLC1d0ebe9a-cbc5-1765-e063-6294a90aa4762024-07-18WarningsExact identifier
application number: M016
Kidgets Baby Petroleum JellyBABY PETROLEUM JELLYMIDWOOD BRANDS, LLC.1d0eb8be-13b7-c466-e063-6294a90a93b92024-07-11WarningsExact identifier
application number: M016
IvarestZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDEBlistex Inc6f68cbbb-6269-4bb3-8cc9-50b146703b422024-07-09WarningsExact identifier
application number: M016
Best Choice Diaper RashZINC OXIDETrifecta Pharmaceuticals USA LLC1be37841-e0a8-a0de-e063-6294a90a9eb12024-06-27WarningsExact identifier
application number: M016
Gas Relief Ultra StrengthSIMETHICONEWalgreens00a9164a-1817-4130-9c7f-9f5833c9690f2024-06-26WarningsExact identifier
application number: M016
Astonea Skin ProtectantZINC OXIDEASTONEA LABS PRIVATE LIMITEDe3c7a515-3e77-da85-e053-2995a90a3ee12024-06-25WarningsExact identifier
application number: M016
Astonea Vitamin A and DWHITE PETROLATUMASTONEA LABS PRIVATE LIMITEDef7c357b-5ff6-b9d7-e053-2a95a90a1dcf2024-06-25WarningsExact identifier
application number: M016
ZOEY NATURALS DIAPER CreamZINC OXIDEAbsolutely Natural70fac4d6-8833-4799-b6b6-796f8f13f80e2024-06-25WarningsExact identifier
application number: M016
Medicated BodyMENTHOL AND ZINC OXIDEUniversal Distribution Center LLC2a59a847-cc7a-42cf-b49a-92e7254c16292024-06-19WarningsExact identifier
application number: M016
THERA Moisturizing Body ShieldDIMETHICONEMcKesson Medical-Surgical Inc.56869b64-11ee-4df6-8102-ce5818e0116e2024-06-18WarningsExact identifier
application number: M016
DimethiconeSKIN PROTECTANTMcKesson96886b33-44d4-5a2a-e053-2a95a90a505e2024-06-18WarningsExact identifier
application number: M016
Derma E Eczema ReliefOATMEALderma e767c4a76-8ccb-4530-9b4b-a7ea1a596c7f2024-06-18WarningsExact identifier
application number: M016
Insect sting relief pad 01SODIUM BICARBONATECosmuses Cosmetics (Ningbo) Co., Ltd.1b0f0088-6482-6de7-e063-6294a90aeeb72024-06-17WarningsExact identifier
application number: M016
THERA Calazinc Body ShieldZINC OXIDEMcKesson Medical-Surgical Inc.974b1046-83ee-4207-91d3-40982beb9c632024-06-17WarningsExact identifier
application number: M016
DimethiconeBODY CLEANSERMcKesson8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a82024-06-14WarningsExact identifier
application number: M016
Dr. Mom Butt BalmDIMETHICONE PETROLATUMFerndale Laboratories, Inc.ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd2024-06-13WarningsExact identifier
application number: M016
Secura ProtectivePETROLATUMSmith & Nephew Medical Ltd20906566-fbf2-46d9-a5d8-c7f7356d10802024-06-12WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
application number: M016
CVS Health Vitamin A and D Skin ProtectantLANOLIN AND PETROLATUMCVS Healthfe3ccabb-9644-4091-9dca-ffd96a43ecaf2024-05-28WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper RashZINC OXIDEBabo Botanicals, Inc.186a9642-cd73-adfb-e063-6394a90a75c72024-05-14WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82046-483-01820460483011 TUBE in 1 CARTON (82046-483-01) / 9 g in 1 TUBE1 tube2026-05-20NoNoCurrent
82046-483-02820460483022 TUBE in 1 CARTON (82046-483-02) / 9 g in 1 TUBE2 tube2026-05-20NoNoCurrent