FDA.reportPublic FDA data

Rugby Petrolatum Hydrating

Product NDC
0536-1143
11-digit product format
005361143
Labeler code
0536
Product ID
0536-1143_99e8ec3b-a809-42ff-a6fe-1f7affd50ac9
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Rugby Laboratories
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-05-31
Substance
PETROLATUM
Active strength
420 mg/g
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
Rugby Petrolatum Hydrating
Brand name suffix
Skin Protectant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM420 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
835547Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ad63e345-1fe8-4f9a-a32e-8dfcde31bedcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1143-97Rugby Petrolatum HydratingSkin Protectant100 g in 1 JAROINTMENT1005
0536-1143-98Rugby Petrolatum HydratingSkin Protectant454 g in 1 JAROINTMENT4545

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1143-97GM - Gram0536-1143ec4cc60b-e6e3-4082-9826-bb59993637cb12018-08-13
0536-1143-98GM - Gram0536-1143620099ab-55ee-4f1e-97a2-9d0c7bf5494112018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1143RUGBY PETROLATUM HYDRATING SKIN PROTECTANT (PETROLATUM) OINTMENT [RUGBY LABORATORIES]4Current NDC, Legacy NDC, 2 package rows20240214_ad63e345-1fe8-4f9a-a32e-8dfcde31bedc.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 4 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petroleum Jelly, Lil Drug StorePETROLATUM JELLYLil' Drug Store Products, Inc.5862af40-97e2-d792-e063-6394a90a0f1a2026-08-06WarningsExact identifier
application number: M016
AOAO RAPID ACNE RELIEFSALICYLIC ACID,BENZOYL PEROXIDEGuangzhou Senmai Biotechnology Co.,Ltd.586df874-0f71-ed46-e063-6294a90a0a8e2026-08-06WarningsExact identifier
application number: M016
Dealmed Vitamins A and DWHITE PETROLATUMDealmed Medical Supplies, LLC.d6584809-b438-4b2c-ab37-522e0dbef4702026-08-05WarningsExact identifier
application number: M016
Dealmed Vitamins A and DPETROLATUMDealmed Medical Supplies, LLC.84afe4ae-f9e8-406f-9fbe-f413975f86eb2026-08-05WarningsExact identifier
application number: M016
Petroleum JellyPETROLATUMWalgreens1bb250ee-c4b7-4e9f-9d13-46ef9df4a9f52026-08-04WarningsExact identifier
application number: M016
Nail Treatment Repairing LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.57b8b3e5-88be-3a91-e063-6294a90a05be2026-08-03WarningsExact identifier
application number: M016
PROCUREZINC OXIDETWIN MED, LLCe68ae97e-668e-31c2-e053-2995a90ab4d32026-08-03WarningsExact identifier
application number: M016
PROCURE VITAMIN A AND D Skin ProtectantPETROLATUMTWIN MED, LLCbbbca68e-1b65-49b1-a5fa-ed4da55d05e32026-08-03WarningsExact identifier
application number: M016
procurePETROLATUMTWIN MED, LLC32520d8f-91ee-47a1-9129-bf0746791f4b2026-08-03WarningsExact identifier
application number: M016
ProCure HydroShieldPETROLATUM 44.28%Twin Med LLC3ab7bfb2-bbcf-0822-e063-6294a90af0842026-08-03WarningsExact identifier
application number: M016
456 Acne Relief CreamNIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOTGuangzhou Senmai Biotechnology Co.,Ltd.5830fd36-0613-1980-e063-6294a90adfb72026-08-03WarningsExact identifier
application number: M016
Crogooe Skin Relief CreamCOLLOIDAL OATMEALGuangdong Outeli Biotechnology Co., Ltd.57f9b3e8-25d3-2b20-e063-6394a90aaea52026-08-01WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALJCS Global Distribution, Inc.57c3556a-aad3-3e65-e063-6394a90ab6892026-07-29WarningsExact identifier
application number: M016
DERMFREE INSECT BITE RELIEFSODIUM BICARBONATE 5% INSECT BITE RELIEFWenzhou Yuyuan Pharmaceutical Co., Ltd.5794886c-0d74-9f35-e063-6394a90a27d82026-07-27WarningsExact identifier
application number: M016
OKeeffes Lip Repair SEAL and HEALPETROLATUMThe Gorilla Glue Company/O'Keeffe's Company55f66f54-da39-76c7-e063-6394a90aeda92026-07-27WarningsExact identifier
application number: M016
ATTITUDE Baby Leaves Diaper cream - UnscentedZINC OXIDE9055-7588 Quebec Inc. (Attitude)579aa481-f8ec-b263-e063-6394a90a77542026-07-27WarningsExact identifier
application number: M016
Boo Boo Magic Diaper Rash CreamyZINC OXIDEAlboo Brands LLC5114aff8-adde-e610-e063-6294a90a77ea2026-07-27WarningsExact identifier
application number: M016
PrevaDRM Vitamin RepairSKIN PROTECTANTSion Brands LLC579e4639-a742-1901-e063-6294a90a2d452026-07-27WarningsExact identifier
application number: M016
Hello Bello Diaper Rash CreamZINC OXIDETopiderm, Inc.e158ba31-e159-4624-a490-fe70baaf4a392026-07-24WarningsExact identifier
application number: M016
Gethorey Vein Target Microneedle PatchALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57593145-a874-15d9-e063-6294a90a77d92026-07-24WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835547petrolatum 42 % Topical OintmentPSNad63e345-1fe8-4f9a-a32e-8dfcde31bedc5
835547petrolatum 0.42 MG/MG Topical OintmentSCDad63e345-1fe8-4f9a-a32e-8dfcde31bedc5
835547petrolatum 42 % Topical OintmentSYad63e345-1fe8-4f9a-a32e-8dfcde31bedc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1143-9700536114397100 g in 1 JAR (0536-1143-97) 100 g2018-05-310000-00-00NoNoCurrent
0536-1143-9800536114398454 g in 1 JAR (0536-1143-98) 454 g2018-05-310000-00-00NoNoCurrent