FDA.reportPublic FDA data

Rugby Zinc Oxide 20%

Product NDC
0536-1316
11-digit product format
005361316
Labeler code
0536
Product ID
0536-1316_5d2e62c5-8697-d462-e063-6294a90a1e0a
Type
HUMAN OTC DRUG
Nonproprietary name
Rugby Zinc Oxide 20%
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Rugby Laboratories
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-01
Substance
ZINC OXIDE
Active strength
20 g/100g
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
Rugby Zinc Oxide 20%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 g/100g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1316-25Rugby Zinc Oxide 20%60 g in 1 TUBEOINTMENT606
0536-1316-25Rugby Zinc Oxide 20%72 in 1 CASEOINTMENT726
0536-1316-28Rugby Zinc Oxide 20%30 g in 1 TUBEOINTMENT306
0536-1316-28Rugby Zinc Oxide 20%72 in 1 CASEOINTMENT726
0536-1316-98Rugby Zinc Oxide 20%454 g in 1 JAROINTMENT4546
0536-1316-98Rugby Zinc Oxide 20%12 in 1 CASEOINTMENT126

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1316-25GM - Gram0536-131603066ba2-e4a9-470e-a8fc-9110a0803a7c12021-11-09
0536-1316-28GM - Gram0536-1316ff471737-fdb6-4acf-a74c-c60bdab10fbf12021-08-05
0536-1316-98GM - Gram0536-13163fe0d57f-53b4-43d8-9994-15e131f7e87e12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1316RUGBY ZINC OXIDE 20% OINTMENT [RUGBY LABORATORIES]5Current NDC, Legacy NDC, 6 package rows20241127_b96f6697-c912-7d62-e053-2a95a90a9f5b.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 8 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zinc Oxide 20%ZINC OXIDETrifecta Pharmaceuticals USA8cbe9b1f-fec0-9579-e053-2995a90ac4612026-06-22WarningsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMWalmart Inc.e294a871-ae73-4a4f-89a3-9ebf0b4fd03a2026-06-19Warnings, Adverse reactionsExact identifier
application number: M016
Diaper Rash CreamZINC OXIDEFoshan Desha Biotechnology Co., Ltd.5487ad62-3d73-042e-e063-6394a90afe8c2026-06-18WarningsExact identifier
application number: M016
Baby HealingOintmentPETROLATUMFoshan Desha Biotechnology Co., Ltd.5488b81a-e5fe-1452-e063-6394a90a2ae42026-06-18WarningsExact identifier
application number: M016
Baby Eczema Moisturizing CreamCOLLOIDAL OATMEALFoshan Desha Biotechnology Co., Ltd.548a0c34-6aac-14f7-e063-6394a90ae6522026-06-18WarningsExact identifier
application number: M016
Jell with Vitamin A DLANOLIN, PETROLATUMJell Pharmaceuticals Pvt Ltd.d976e5f0-1be5-d9c4-e053-2a95a90a44a42026-06-17WarningsExact identifier
application number: M016
DoveANTIBACTERIAL CARE BEAUTY BARConopco d/b/a Unilever547472cf-4902-584e-e063-6294a90a28ac2026-06-17WarningsExact identifier
application number: M016
Dr Sosnowskis Chafing Hero Severe Chafing BalmLANOLINHerstat (USA) Inc.389041a8-7316-b38e-e063-6294a90a3e8e2026-06-17WarningsExact identifier
application number: M016
Drs. Pharmacy Creamy Cocoa Butter Petroleum JellyWHITE PETROLATUMOL PHARMA TECH, LLC Drs PHARMACY546749e3-70c5-10e8-e063-6294a90ad8c42026-06-16WarningsExact identifier
application number: M016
Drs. Pharmacy Creamy Petroleum JellyWHITE PETROLATUMOL PHARMA TECH, LLC Drs PHARMACY54698388-f9e8-c470-e063-6394a90a783b2026-06-16WarningsExact identifier
application number: M016
MedlineZINC OXIDEMedline Industries, LP3c319953-04fc-87a8-e063-6294a90a50582026-06-15WarningsExact identifier
application number: M016
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
application number: M016
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
application number: M016
HEALMUSZ HEALTHY FEETUREA 40% SALICYLIC ACID 2% GREEN TEA LEAFL 1% COCONUT OIL 1% HEALTHY FEETJiangxi Yudexi Pharmaceutical Co., LTD4a34b6de-03ec-3be4-e063-6294a90afb522026-06-14WarningsExact identifier
application number: M016
PUVIDA SNOW BLEACHNIACINAMIDE 15% SNOW BLEACHJiangxi Yudexi Pharmaceutical Co., LTD4a48ebbd-7c80-1bce-e063-6294a90ab4ae2026-06-14WarningsExact identifier
application number: M016
XIMONTH Foot Shoe DeodorizerGLYCERINShantou Ximonth Biotechnology Co., Ltd.541d9ce9-62ad-847e-e063-6394a90a55e02026-06-13WarningsExact identifier
application number: M016
Skin Protectant with 33% Petrolatum Advance Moisturizing CreamPETROLATUMAldermed Inc.87413149-d39f-4f8a-b1c9-6de5eb37ff7e2026-06-12WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDE, WHITE PETROLATUMAldermed Inc.54154a72-27ad-7bfa-e063-6394a90a4eca2026-06-12WarningsExact identifier
application number: M016
Circletong Tag Wart Remover PatchesGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.541b0fe9-f900-8191-e063-6394a90af3212026-06-12WarningsExact identifier
application number: M016
Baby ButzZINC OXIDEOlen Skin Care Corporatione6be6b62-13a4-410d-b8ac-457b58fd23da2026-06-10WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198911zinc oxide 20 % Topical OintmentPSNb96f6697-c912-7d62-e053-2a95a90a9f5b6
198911zinc oxide 0.2 MG/MG Topical OintmentSCDb96f6697-c912-7d62-e053-2a95a90a9f5b6
198911zinc oxide 20 % Topical OintmentSYb96f6697-c912-7d62-e053-2a95a90a9f5b6
198911zinc oxide 200 MG per GM Topical OintmentSYb96f6697-c912-7d62-e053-2a95a90a9f5b6
198911ZNO 0.2 MG/MG Topical OintmentSYb96f6697-c912-7d62-e053-2a95a90a9f5b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1316-250053613162572 TUBE in 1 CASE (0536-1316-25) / 60 g in 1 TUBE72 tube2021-03-010000-00-00NoNoCurrent
0536-1316-280053613162872 TUBE in 1 CASE (0536-1316-28) / 30 g in 1 TUBE72 tube2021-03-010000-00-00NoNoCurrent
0536-1316-980053613169812 JAR in 1 CASE (0536-1316-98) / 454 g in 1 JAR12 jar2021-03-010000-00-00NoNoCurrent