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 3 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DawnMist White PetrolatumWHITE PETROLATUMDukal LLC598e9d46-6450-af60-e063-6394a90a3a6b2026-08-21WarningsExact identifier
application number: M016
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela163f388e-849d-4b7e-93c1-9045d77a9ec22026-08-21WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP0073de92-585d-e01a-e063-6394a90a2ec22026-08-21WarningsExact identifier
application number: M016
Mederma PMDIMETHICONEL Perrigo Company8c728904-28f4-4333-a9ea-20996fd1b0072026-08-21WarningsExact identifier
application number: M016
Earths Care Hemorrhoid ReliefWITCH HAZEL AND MENTHOL, UNSPECIFIED FORMDLC Laboratories, Inc.e860d65b-126d-4d77-8003-9d1381849ab52026-08-20WarningsExact identifier
application number: M016
ClaraViePETROLATUMGentell LLC596987e4-4205-b911-e063-6294a90aa5702026-08-19WarningsExact identifier
application number: M016
ClaraVieZINC OXIDEGentell LLC596abd98-17d7-2a22-e063-6294a90af57d2026-08-19WarningsExact identifier
application number: M016
Claravie Skin Repair CreamDIMETHICONEGentell LLC596ae269-172e-aef5-e063-6394a90a4e2a2026-08-19WarningsExact identifier
application number: M016
ClaravieLANOLINGentell LLC596c1b73-e34d-c97d-e063-6394a90ada1b2026-08-19WarningsExact identifier
application number: M016
ClaraVieMENTHOL, ZINC OXIDEGentell LLC596c467f-a056-ea78-e063-6394a90a79f22026-08-19WarningsExact identifier
application number: M016
ClaraVieLANOLINGentell LLC596fe32d-be34-0635-e063-6394a90a2fc02026-08-19WarningsExact identifier
application number: M016
MedprideZINC OXIDEShield Line LLCe2689cae-e347-4c0b-825b-6281a0b7c2f12026-08-18WarningsExact identifier
application number: M016
Eczema Skin Relief CreamCOLLOIDAL OATMEALCVS Health98fac854-f7b0-4c6e-888d-1bdc6b9323b92026-08-17WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEADUSA Distribution, LLC5940399c-31e3-6d51-e063-6294a90a8e7c2026-08-17Warnings, Adverse reactionsExact identifier
application number: M016
Intimate CareGelHYALURONIC ACIDGuangzhou Yilong Cosmetics.,Ltd5918d204-52db-e6d0-e063-6394a90ab78c2026-08-14WarningsExact identifier
application number: M016
TENA Proskin protective creamZINC OXIDEEssity HMS North America Inc.b840377f-a297-4aff-900e-7ea8b7c987172026-08-13Warnings, Adverse reactionsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP087d66ff-1a8c-dcb2-e063-6294a90a2f8c2026-08-11WarningsExact identifier
application number: M016
Nail Renewal LiquidGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.581f7192-fc17-a706-e063-6394a90a3ffa2026-08-11WarningsExact identifier
application number: M016
Intertrigo Relief CreamGLYCERINShantou South Moon Biotechnology Co., Ltd.587220c9-0ae9-3438-e063-6394a90a0a862026-08-07WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact 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