FDA.reportPublic FDA data

PETROLATUM and LANOLIN

Product NDC
59779-098
11-digit product format
597790098
Labeler code
59779
Product ID
59779-098_eea14fa9-9c3c-4b8a-b8d0-3bdd468dd7ff
Type
HUMAN OTC DRUG
Nonproprietary name
PETROLATUM and LANOLIN
Dosage form
OINTMENT
Route
TOPICAL
Labeler
CVS
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-05-19
Marketing end
0000-00-00
Substance
PETROLATUM; LANOLIN
Active strength
534 mg/g; mg/g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59779-098IInactivated by FDA2026-07-31
excluded packagepackage59779-09859779-098-02IInactivated by FDA2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AstringentCALCIUM ACETATE MONOHYDRATE AND ALUMINUM SULFATE TETRADECAHYDRATEGranulation Technology, Inc.1c2bf19c-2f32-4a22-a371-16cc744dce762025-06-12WarningsExact identifier
PetrolatumPETROLATUMGreenbrier International, Inc.91f24a0c-276f-4962-8da8-462b1f42040e2019-05-17WarningsExact identifier
Eczema Care Moisturizing 3 oz.COLLOIDAL OATMEALRejoice International Inc.83967d26-159a-e95c-e053-2991aa0af53a2019-03-08WarningsExact identifier
Oatmeal Skin Relief Calming . 8ozDIMETHICONERejoice International Inc.8384dc52-ba36-da3d-e053-2a91aa0a4f402019-03-07WarningsExact identifier
PetrolatumPETROLATUMGreenbrier International, Inc.b8832ee7-3e13-456b-b301-dad7473a032b2019-02-04WarningsExact identifier
BURTS BEES BABY BEE DIAPER RASHZINC OXIDEBURT'S BEES, INC.168b31b1-9260-61f8-e054-00144ff8d46c2018-12-21WarningsExact identifier
Balmex Diaper RashZINC OXIDERandob Labs,Ltd.f202dd0e-7c61-4ea1-a5f6-e90898366ba32018-11-13WarningsExact identifier
BALMEX ADULT CARE RASHZINC OXIDERandob Labs,Ltd.9443a987-c7b2-4b0d-a9dc-02233135af812018-11-13WarningsExact identifier
BALMEX MULTI-PURPOSEPETROLATUMRandob Labs,Ltd.83a9ba1a-b708-47e2-a4a3-ef847e1bb7922018-11-13WarningsExact identifier
Natures Choice Vitamins A and DA AND D OINTMENTUnipack, Inc.17861122-2231-4a54-b3d8-894153c708d72018-01-15WarningsExact identifier
MG217 Eczema FaceCOLLOIDAL OATMEALWisconsin Pharmacal Company5f10697e-7f0c-f2b7-e053-2991aa0aabde2017-11-30WarningsExact identifier
MG217 Baby EczemaCOLLOIDAL OATMEALWisconsin Pharmacal Company5d65052d-2972-544d-e053-2a91aa0afa3e2017-11-28WarningsExact identifier
Vitamin A and DLANOLIN AND PETROLATUMFamily Dollar Services Inc4826b36d-3326-4f5c-8b22-c5ff79e550622017-11-08WarningsExact identifier
TriCalm HydrogelALUMINUM ACETATEModular Thermal Technologies LLC Dba Life Wear Technologies5cb42ffb-3655-4c38-bf84-1cf33c82df102017-03-23WarningsExact identifier
CVS Health Diaper RashZINC OXIDECVS Health12f786a0-0960-4b98-9f0b-dcf3725a98662017-03-20WarningsExact identifier
ARGAN AIR WATER BANG ESSENCEDIMETHICONEPioom Cosmetic Co.,ltd34e79668-0710-5753-e054-00144ff88e882016-06-08WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only When using this product Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not cover compress or wet dressing with plastic to prevent evaporation In some skin conditions, soaking too long may overdry Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59779-098-022019-10-29C16284748780-1960f7f55-d03a-8e05-e053-dbdaa90a074adrug facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-098-02PETROLATUM and LANOLIN113 g in 1 TUBEOINTMENT1136

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANOLINACTIVE INGREDIENT7EV65EAW6HPETROLATUM AND LANOLIN OINTMENT [CVS]6
PETROLATUMACTIVE INGREDIENT4T6H12BN9UPETROLATUM AND LANOLIN OINTMENT [CVS]6
LANOLINACTIVE MOIETY7EV65EAW6HPETROLATUM AND LANOLIN OINTMENT [CVS]6
PETROLATUMACTIVE MOIETY4T6H12BN9UPETROLATUM AND LANOLIN OINTMENT [CVS]6
CARROT SEED OILINACTIVE INGREDIENT595AO13F11PETROLATUM AND LANOLIN OINTMENT [CVS]6
COD LIVER OILINACTIVE INGREDIENTBBL281NWFGPETROLATUM AND LANOLIN OINTMENT [CVS]6
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYPETROLATUM AND LANOLIN OINTMENT [CVS]6
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPPETROLATUM AND LANOLIN OINTMENT [CVS]6
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEPETROLATUM AND LANOLIN OINTMENT [CVS]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-098PETROLATUM AND LANOLIN OINTMENT [CVS]6Legacy NDC, 1 package rows20110509_52b8ff16-c431-411f-a068-24df8579c2d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentPSN52b8ff16-c431-411f-a068-24df8579c2d46
664981lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical OintmentSCD52b8ff16-c431-411f-a068-24df8579c2d46
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentSY52b8ff16-c431-411f-a068-24df8579c2d46
664981lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical OintmentSY52b8ff16-c431-411f-a068-24df8579c2d46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
59779-098-0259779009802113 g in 1 TUBE113 gHistorical