FDA.reportPublic FDA data

Skin Protectant

Product NDC
41190-180
11-digit product format
411900180
Labeler code
41190
Product ID
41190-180_4aba4155-2410-201f-e063-6394a90a4e1e
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Wakefern Food Corp.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-06
Substance
PETROLATUM
Active strength
410 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
Skin Protectant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM410 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
725145Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b799229b-f7ca-494c-afde-1fd096aef66eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41190-180-21Skin Protectant85 g in 1 TUBEOINTMENT853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41190-180SKIN PROTECTANT (PETROLATUM) OINTMENT [WAKEFERN FOOD CORP]2Current NDC, 1 package rows20250507_b799229b-f7ca-494c-afde-1fd096aef66e.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 67 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
calahistCALAMINE AND PRAMOXINE HYDROCHLORIDEWALGREEN COMPANYfed45e06-cc53-fbc5-e053-6294a90a1b192023-10-27WarningsExact identifier
application number: M016
calahist clearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEWALGREEN COMPANYfed469c2-fe13-6726-e053-6394a90a5f512023-10-27WarningsExact identifier
application number: M016
Dr. Sayman SalveSALVESheffield Pharmaceuticals LLC18bdcd0c-9c81-47e1-ae24-2239ff8fd0662023-10-24WarningsExact identifier
application number: M016
Theriac Advanced HealingLANOLINSheffield Pharmaceuticals LLCc780cd27-dc9e-45f3-97f0-e59b1b6b955a2023-10-24WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper RashZINC OXIDEBabo Botanicals, Inc.d66e369e-9b19-b084-e053-2995a90aa2592023-10-23WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby HealingCOLLOIDAL OATMEALBabo Botanicals, Inc.08659a5c-2d10-2f98-e063-6394a90a77602023-10-23WarningsExact identifier
application number: M016
White Rose Petroleum JellyPETROLATUMJ. Strickland & Co.1aeb090d-c103-4c2e-accc-d9d248315db92023-10-21WarningsExact identifier
application number: M016
Tricalm HydrogelALUMINUM ACETATEMODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES082c6441-be47-4466-e063-6394a90ad5002023-10-20WarningsExact identifier
application number: M016
EmpowerWHITE PETROLATUM, ZINC OXIDEBemis Manufacturing Company Inc08006b60-966b-155b-e063-6294a90a206a2023-10-18WarningsExact identifier
application number: M016
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
application number: M016
AnubisMedSODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREAANUBIS COSMETICS SLebf4b3ab-34e1-185a-e053-2a95a90ace3a2023-09-05WarningsExact identifier
application number: M016
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaDMAEANUBIS COSMETICS SLf22b212d-d21d-5984-e053-2995a90a683e2023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Vital LineHYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDESANUBIS COSMETICS SLebe024f7-7c45-ad60-e053-2995a90a45d62023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaPROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOLANUBIS COSMETICS SLebdddcec-f5da-51fe-e053-2995a90a61672023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaPROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATEANUBIS COSMETICS SLeb53cba1-0509-43bc-e053-2995a90a5e092023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
725145petrolatum 41 % Topical OintmentPSNb799229b-f7ca-494c-afde-1fd096aef66e3
725145petrolatum 0.41 MG/MG Topical OintmentSCDb799229b-f7ca-494c-afde-1fd096aef66e3
725145petrolatum 41 % Topical OintmentSYb799229b-f7ca-494c-afde-1fd096aef66e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
41190-180-214119001802185 g in 1 TUBE (41190-180-21) 85 g2024-05-06NoNoCurrent