FDA.reportPublic FDA data

CeraVe Developed with Dermatologists Healing

Product NDC
49967-500
11-digit product format
499670500
Labeler code
49967
Product ID
49967-500_1c801d2d-efb6-497e-9c2d-9394436ec934
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
L'Oreal USA Products Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-09-20
Substance
PETROLATUM
Active strength
46.5 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM46.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1728288Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1b3ad3e8-cbac-4a92-84e2-4f3ab4512d95Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-500-01CeraVe Developed with Dermatologists Healing340 g in 1 JAROINTMENT3406
49967-500-02CeraVe Developed with Dermatologists Healing85 g in 1 TUBEOINTMENT856
49967-500-03CeraVe Developed with Dermatologists Healing144 g in 1 TUBEOINTMENT1446
49967-500-04CeraVe Developed with Dermatologists Healing2.5 g in 1 JAROINTMENT2.56
49967-500-04CeraVe Developed with Dermatologists Healing15 in 1 TRAYOINTMENT156
49967-500-05CeraVe Developed with Dermatologists Healing10 g in 1 TUBEOINTMENT106
49967-500-06CeraVe Developed with Dermatologists Healing2 in 1 CARTONOINTMENT26
49967-500-06CeraVe Developed with Dermatologists Healing10 g in 1 TUBEOINTMENT106
49967-500-07CeraVe Developed with Dermatologists Healing53.6 g in 1 TUBEOINTMENT53.66
49967-500-08CeraVe Developed with Dermatologists Healing5 g in 1 JAROINTMENT56
49967-500-08CeraVe Developed with Dermatologists Healing1 in 1 BLISTER PACKOINTMENT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-500CERAVE DEVELOPED WITH DERMATOLOGISTS HEALING (PETROLATUM) OINTMENT [L'OREAL USA PRODUCTS INC.]6Current NDC, Legacy NDC, 11 package rows20240101_1b3ad3e8-cbac-4a92-84e2-4f3ab4512d95.zip

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 10 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EELHOE Cuticle Pusher PenGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.52c7f956-a2a1-ae1d-e063-6294a90ab3c22026-05-27WarningsExact identifier
application number: M016
Dermoia Eczema Relief Colloidal OatmealOATMEALTreasurewise LLC1285c0a4-5fdf-4691-a8c6-1de8e2e2f66a2026-05-27WarningsExact identifier
application number: M016
CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEWal-Mart Stores, Inc.61e76e2a-fc46-7a64-e053-2991aa0a56a82026-05-26WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEWal-Mart Stores, Inc.61929c97-bd6b-0d7c-e053-2991aa0aa5712026-05-26WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEPharma Nobis, LLCfbcfa541-beda-06de-e053-6294a90a92982026-05-26WarningsExact identifier
application number: M016
Humco CalamineCALAMINE 8% AND ZINC OXIDE 8%Humco holding Group, Inc.f7dcd959-fb98-43bb-8dd3-a662bf8a053c2026-05-26WarningsExact identifier
application number: M016
Advanced HealingPETROLATUMCVS Pharamacy, Inc0bd3380e-2284-44a7-b2ef-68c9909627fd2026-05-26Warnings, Adverse reactionsExact identifier
application number: M016
CeraVe Developed with Dermatologists Healing Lip BalmPETROLATUML'Oreal USA Products Inc21dc8842-0672-4d46-bcea-b8e3d54c48bf2026-05-20WarningsExact identifier
application number: M016
AFTER CAREDIMETHICONEMerz North Americac19c5ffe-3b62-43e1-83c2-d89c7b9aa2ae2026-05-20WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDETrifecta Pharmaceuticals USA63b551fc-7d16-c099-e053-2a91aa0a5f2c2026-05-18WarningsExact identifier
application number: M016
ADVANCED SILICONE SCARALLANTOINYantai Aien Biotechnology Co., Ltd.51ffdc45-5acf-ae20-e063-6294a90a55e82026-05-17WarningsExact identifier
application number: M016
LCFateLC Nail LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.51ea23f4-0a23-4ae1-e063-6394a90aa0512026-05-16WarningsExact identifier
application number: M016
Radlive Active Defense Nano-Silver CreamCOLLOIDAL OATMEALSilverCeuticals51e23135-008d-9db5-e063-6294a90a7d612026-05-15WarningsExact identifier
application number: M016
Cerave Developed with Dermatologists HealingPETROLATUMLOreal USA Products Incde44ac01-ba17-4f97-ac12-9ea348013bde2026-05-14WarningsExact identifier
application number: M016
Triple 3x Max Diaper RashZINC OXIDEAdvantice Health, LLCe554046b-cd0a-4a6e-8f24-2e610c6974322026-05-14WarningsExact identifier
application number: M016
Eczema TherapyCOLLOIDAL OATMEALSilverCeuticals3a26a35e-a098-0e22-e063-6294a90a96b92026-05-13WarningsExact identifier
application number: M016
Nail- PflasterGLYCERINShantou Ximonth Biotechnology Co., Ltd.519681bc-6312-f627-e063-6394a90a28452026-05-11WarningsExact identifier
application number: M016
HydratingPETROLATUMAldermed Inc.4aa6a354-e487-4b65-e063-6394a90abbf02026-05-09WarningsExact identifier
application number: M016
Diaper RashZINC OXIDEAldermed Inc.4aa79292-dc91-b538-e063-6294a90ac3f02026-05-09WarningsExact identifier
application number: M016
XIMONTH Nail Fungus Care LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.514a998d-aa2a-46b6-e063-6294a90a6c222026-05-08WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1728288petrolatum 46.5 % Topical OintmentPSN1b3ad3e8-cbac-4a92-84e2-4f3ab4512d956
1728288petrolatum 0.465 MG/MG Topical OintmentSCD1b3ad3e8-cbac-4a92-84e2-4f3ab4512d956
1728288petrolatum 46.5 % Topical OintmentSY1b3ad3e8-cbac-4a92-84e2-4f3ab4512d956

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-500-0149967050001340 g in 1 JAR (49967-500-01) 340 g2017-09-200000-00-00NoNoCurrent
49967-500-024996705000285 g in 1 TUBE (49967-500-02) 85 g2017-09-200000-00-00NoNoCurrent
49967-500-0349967050003144 g in 1 TUBE (49967-500-03) 144 g2017-09-200000-00-00NoNoCurrent
49967-500-044996705000415 JAR in 1 TRAY (49967-500-04) / 2.5 g in 1 JAR15 jar2017-09-200000-00-00NoNoCurrent
49967-500-054996705000510 g in 1 TUBE (49967-500-05) 10 g2017-09-200000-00-00NoNoCurrent
49967-500-06499670500062 TUBE in 1 CARTON (49967-500-06) / 10 g in 1 TUBE2 tube2017-09-200000-00-00NoNoCurrent
49967-500-074996705000753.6 g in 1 TUBE (49967-500-07) 53.6 g2017-09-200000-00-00NoNoCurrent
49967-500-08499670500081 JAR in 1 BLISTER PACK (49967-500-08) / 5 g in 1 JAR1 jar2017-09-20NoNoCurrent