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 2 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petroleum Skin ProtectantWHITE PETROLATUMYour Military Exchanges1a0aed14-8606-4676-b4b5-23dd415d43ac2026-09-02Warnings, Adverse reactionsExact identifier
application number: M016
Aloetouch Protect Fragrance FreeDIMETHICONEMedline Industries, LP81f0071b-2bf3-455b-9e5d-8f3ca20adcdf2026-09-01WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED5a57b197-3e18-b3ab-e063-6394a90aed822026-08-31WarningsExact identifier
application number: M016
HYDROPHORHYDROPHORAkron Pharma Inc.e6099df7-d418-479a-9d2e-ced523585aed2026-08-28WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELUnited Natural Foods, Inc. dba UNFId2d1bd9e-7025-4151-95f2-a2f521dc2be82026-08-28Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONEYour Military Exchangese7af5488-1c49-41e9-9d8b-d519c61076992026-08-28Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
application number: M016
Estriol CreamESTRIOLGuangxi Keyun E-commerce Co., Ltd.4deadcb6-0d46-bdd7-e063-6294a90a26d72026-08-27WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP0d964138-f68d-dbf5-e063-6294a90a83202026-08-27WarningsExact identifier
application number: M016
Gembooxt ECZEMA RELIEF CreamHYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.46490d65-f789-eaa2-e063-6294a90a623b2026-08-27WarningsExact identifier
application number: M016
Serawise Eczema ReliefOATMEALDrAnaMaria. Com LLCf0681436-d140-4e02-afe4-5b16de07afcd2026-08-26WarningsExact identifier
application number: M016
Hair Regrowth FoamGLYCERINShantou Ouhoe Technology Co., Ltd.59ef5953-e96f-5707-e063-6294a90a30942026-08-26WarningsExact identifier
application number: M016
Growth TreatmentGLYCERINShantou Ouhoe Technology Co., Ltd.59fe12eb-574f-a199-e063-6394a90abd062026-08-26WarningsExact identifier
application number: M016
Acne ReliefSALICYLIC ACID,NIACINAMIDE,PANTHENOL.Guangzhou Senmai Biotechnology Co.,Ltd.59db0143-de57-59d2-e063-6294a90a32a82026-08-25WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELYour Military Exchanges4079fd56-55f3-4e69-93e0-7590c07fb7942026-08-25Warnings, Adverse reactionsExact identifier
application number: M016
Salicylic Acid Acne Gel CleanserSALICYLIC ACID,PANTHENOLGuangzhou Senmai Biotechnology Co.,Ltd.59eb395b-493b-efc9-e063-6294a90aa8912026-08-25WarningsExact identifier
application number: M016
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP0d94fd18-a120-e171-e063-6394a90ae9c02026-08-24WarningsExact identifier
application number: M016
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela59cf1d1e-e951-9d58-e063-6394a90af0f32026-08-24WarningsExact identifier
application number: M016
ClaravieZINC OXIDE, DIMETHICONEGentell LLC598a5c0b-1e2f-1335-e063-6394a90ac4f42026-08-21WarningsExact 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