FDA.reportPublic FDA data

White Petrolatum

Product NDC
0404-0169
11-digit product format
004040169
Labeler code
0404
Product ID
0404-0169_5d417c21-417b-8ba4-e063-6294a90ac2c7
Type
HUMAN OTC DRUG
Nonproprietary name
White Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Henry Schein
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-17
Substance
WHITE PETROLATUM
Active strength
1 g/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
White Petrolatum
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WHITE PETROLATUM1 g/g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-0169-50White Petrolatum864 in 1 CASEOINTMENT8644
0404-0169-50White Petrolatum144 in 1 BOXOINTMENT1444

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-0169WHITE PETROLATUM OINTMENT [HENRY SCHEIN]3Current NDC, Legacy NDC, 2 package rows20241205_eb7a5698-754e-4e46-e053-2a95a90a57b4.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 47 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
A0A0 Rice Ceramide Anti Wrinkle Age Essence Box SetBIFIDA FERMENT LYSATE,ORYZA SATIVA (RICE) EXTRACT,CERAMIDE NP,COLLAGEN,TOCOPHEROL.Guangdong Junhui Biotechnology Co., LTD22736b2d-45a0-49b6-e063-6394a90a7b0b2025-01-08WarningsExact identifier
application number: M016
Body Milk for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,BUTYROSPERMUM PARKII (SHEA) BUTTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,THEOBROMA CACAO (COCOA) SEED BUTTERGuangzhou Senmai Biotechnology Co.1dcd94dc-214d-de72-e063-6294a90a695f2025-01-08WarningsExact identifier
application number: M016
Stretch Marks creamSESAMUM INDICUM (SESAME) SEED EXTRACT,PRUNUS PERSICA (PEACH) RESIN EXTRACT,STERCULIA URENS GUM,TRIPEPTIDE-1,HEXAPEPTIDE-9,ACETYL TETRAPEPTIDE-9,PALMITOYL PENTAPEPTIDE-4,PALMITOYL TETRAPEPTIDE-7,ACETYL HEXAPEPTIDE-8.Guangzhou Senmai Biotechnology Co.1e827483-259a-d12f-e063-6394a90a78852025-01-08WarningsExact identifier
application number: M016
Body oil for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL ,TOCOPHEROL,ADANSONIA DIGITATA SEED 0IL,MORINGA OLEIFERA SEED 0IL,THEOBROMA CACAO (COCOA) SEED BUTTER,ECHIUM PLANTAGINEUM SEED OIL,SESAMUM INDICUM (SESAME) SEED 0ILGuangzhou Senmai Biotechnology Co.1daeb2e8-f18c-06c3-e063-6294a90a63852025-01-08WarningsExact identifier
application number: M016
AOA0 Snail Ginseng CreamSNAIL SECRETION FILTRATE,PANAX GINSENG ROOT EXTRACT,COLLAGEN,TOCOPHEROL,ASCORBIC ACID.Guangdong Junhui Biotechnology Co., LTD22873a99-1032-f4ec-e063-6394a90a64322025-01-08WarningsExact identifier
application number: M016
Massage cream for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL,BUTYROSPERMUM PARKII (SHEA) BUTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,CERAMIDE NP,SOLUBLE COLLAGEN,HYDROLYZED ELASTIN,PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OILGuangzhou Senmai Biotechnology Co.1dce7cf1-1fb8-e14e-e063-6394a90ae34a2025-01-08WarningsExact identifier
application number: M016
AOAO Retinol Anti-aging Box SetCOLLAGEN,BUTYROSPERMUM PARKII (SHEA) BUTTER EXTRACT,HYALURONIC ACID,CAFFEINE,SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL,RETINOL.Guangdong Junhui Biotechnology Co., LTD24fdc31b-5291-a649-e063-6394a90a9c652025-01-08WarningsExact identifier
application number: M016
Sulfur anti-mite shower gelSODIUM LAURETH SULFAT,DECYL GLUCOSIDE,PALM KERNELAMIDE DEA,COCAMIDOPROPYL BETAINE,LONICERA JAPONICA(HONEYSUCKLE) FLOWER EXTRACT,COLLOIDAL SULFUR.Guangdong Junhui Biotechnology Co., Ltd251ee057-1adf-bc97-e063-6394a90acdd32025-01-08WarningsExact identifier
application number: M016
TURMERICFaceCreamNIACINAMIDEShengnan (Guangzhou) Cosmetics Co., LTD2b0652be-a216-d66b-e063-6394a90a0b282025-01-06WarningsExact identifier
application number: M016
Menthol and Zinc OxideMENTHOL AND ZINC OXIDEGERI-GENTLE CORPORATIONe673d8bd-2573-9f04-e053-2995a90a172a2025-01-06WarningsExact identifier
application number: M016
ClearSoothingCreamHYALURONIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD2ac88f9a-a41b-1978-e063-6394a90a24212025-01-03WarningsExact identifier
application number: M016
MILKBODyLotionUREAShengnan (Guangzhou) Cosmetics Co., LTD2ac99028-a811-9332-e063-6294a90aee5c2025-01-03WarningsExact identifier
application number: M016
Royal Jelly Scar BalmDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.27be84c1-0227-41ca-beb6-3855eff77e412025-01-02WarningsExact identifier
application number: M016
Vitamin A and DPETROLATUMTrifecta Pharmaceuticals USA LLCf1ea9640-4a6d-1c76-e053-2a95a90ad3b12024-12-31WarningsExact identifier
application number: M016
Badger DiaperZINC OXIDEW.S. Badger Company, Inc.674542b2-33fb-4664-857d-4ff1d7f768a02024-12-31WarningsExact identifier
application number: M016
A and D Diaper Rash and Skin ProtectantLANOLIN AND PETROLATUMNatureplex LLCfcaf27c9-3634-4fb7-a311-2e093f0552782024-12-31WarningsExact identifier
application number: M016
ELIZABETH ARDEN EIGHT HR PROTECTANT CLEARLIP PROTECTANTREVLON CONSUMER PRODUCTS CORPf3a6fe29-7af7-bfb1-e053-2a95a90a01012024-12-30WarningsExact identifier
application number: M016
SkinCeuticals Advanced Scar Control Skin ProtectantALLANTOINL'Oreal USA Products Inc83f4bfbb-47d8-4fe9-ba33-85142ec6221c2024-12-28WarningsExact identifier
application number: M016
Personal Cleansing with DimethiconeDIMETHICONECardinal Health 200, Inc3f9a1a90-ab12-4911-b8c2-df200b0dde5b2024-12-27WarningsExact identifier
application number: M016
NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT NUDEZINC OXIDEBentley Laboratories, LLCa35ae585-f899-4c7e-8cd2-c0b2fe6a20782024-12-27WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204754petrolatum 100 % Topical JellyPSNeb7a5698-754e-4e46-e053-2a95a90a57b44
204754petrolatum 1 MG/MG Topical OintmentSCDeb7a5698-754e-4e46-e053-2a95a90a57b44
204754petrolatum 100 % Topical JellySYeb7a5698-754e-4e46-e053-2a95a90a57b44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-0169-5000404016950864 BOX in 1 CASE (0404-0169-50) / 144 PACKET in 1 BOX / 5 g in 1 PACKET864 box2022-11-170000-00-00NoNoCurrent