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 5 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fresh Scent PROTECTIVE BABYZINC OXIDECVS Pharmacy, Inc.3f33c62c-43ec-4576-a24d-bd5de07e74d22026-07-23WarningsExact identifier
application number: M016
DERMFREE Vein Target Microneedle PatchALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57449e29-ec46-9c30-e063-6394a90a7b4a2026-07-23WarningsExact identifier
application number: M016
Baby Vitamin A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a125ea-6f9f-310c-e063-6394a90acef22026-07-22WarningsExact identifier
application number: M016
First Aid A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a319d0-d39a-5ff0-e063-6394a90a671d2026-07-22WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
application number: M016
DermasporinLANOLINMarie's Original Formulas LLC562f40aa-eeec-2b7c-e063-6294a90ad68d2026-07-22WarningsExact identifier
application number: M016
CAREALL Vitamin A and DPETROLATUMNew World Imports, Incef89a68a-74c1-4c42-8078-b7a208ace0de2026-07-22WarningsExact identifier
application number: M016
DermactLANOLINMarie's Original Formulas LLC57121dbe-e886-a562-e063-6294a90a367f2026-07-22WarningsExact identifier
application number: M016
Universal WITCH HAZELWITCH HAZELUniversal Distribution Center LLC7e0b56ef-fa41-4862-b387-5b58d81d67d42026-07-22WarningsExact identifier
application number: M016
Aveeno Soothing Bath TreatmentOATMEALKenvue Brands LLC0c410b8e-025f-477c-afac-6e2e9ac88f7d2026-07-21WarningsExact identifier
application number: M016
DERMFREE SCAR SHEETSSILICONE GEL 1% SCAR SHEETSJiangxi Yudexi Pharmaceutical Co., LTD4a4ce316-4b92-7e81-e063-6294a90af6db2026-07-21WarningsExact identifier
application number: M016
DERMFREE VARICOSE VEINSDIMETHICONE 3% VARICOSE VEINSJiangxi Yudexi Pharmaceutical Co., LTD4a5a2d1d-9e84-18eb-e063-6394a90a97ee2026-07-21WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
application number: M016
Mederma Stretch Marks TherapyDIMETHICONEPMI Branded Pharmaceuticals, Inc.0f2918e3-9615-40e3-ab7e-6bfbe022e03c2026-07-16WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
application number: M016
DoveMEN CARE ANTIBACTERIAL CARE MOISTURIZING CREAM BARConopco d/b/a Unilever56bd6fcb-c762-4e5a-e063-6394a90a34382026-07-16WarningsExact identifier
application number: M016
Mederma Advanced ScarALLANTOINPMI Branded Pharmaceuticals, Inc.25bc1eae-3502-4c63-bd8a-43be2dfb0d6d2026-07-16WarningsExact identifier
application number: M016
Mederma Advanced ScarALLANTOINL. Perrigo Company9c3d9e08-9428-4b28-82a2-0cb24c3c92a32026-07-16WarningsExact identifier
application number: M016
aftershaveCERAMIDE NPShengnan (Guangzhou) Cosmetics Co., LTD56a17ac9-803b-932c-e063-6394a90aae902026-07-15WarningsExact identifier
application number: M016
Clear Root Labs Wound CareCRL WOUND CARE OINTMENTAidance Scientific Inc. DBA Aidance Skincare & Topicals56a6dbc7-5001-c095-e063-6294a90a1aa02026-07-15WarningsExact 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