FDA.reportPublic FDA data

Drs. DIAPER RASH MAXIMUM STRENGTH

Product NDC
80489-576
11-digit product format
804890576
Labeler code
80489
Product ID
80489-576_56368fba-54cb-5ca0-e063-6394a90a8abf
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
OL PHARMA TECH, LLC Drs PHARMACY
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-07
Substance
ZINC OXIDE; DIMETHICONE
Active strength
10; 1 g/100g; g/100g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Skin Barrier Activity [PE]
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
Drs. DIAPER RASH MAXIMUM STRENGTH
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE10 g/100g
DIMETHICONE1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
686403Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
161ba174-1b13-83cd-e063-6394a90af19cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
80489-576-01161ba174-1b13-83cd-e063-6394a90af19c
80489-576-01161ba174-1b13-83cd-e063-6394a90af19c
80489-576-02161ba174-1b13-83cd-e063-6394a90af19c
80489-576-02161ba174-1b13-83cd-e063-6394a90af19c
80489-576-03161ba174-1b13-83cd-e063-6394a90af19c
80489-576-03161ba174-1b13-83cd-e063-6394a90af19c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80489-576-01Drs. DIAPER RASH MAXIMUM STRENGTH20 g in 1 TUBECREAM201
80489-576-01Drs. DIAPER RASH MAXIMUM STRENGTH1 in 1 CARTONCREAM11
80489-576-02Drs. DIAPER RASH MAXIMUM STRENGTH1 in 1 CARTONCREAM11
80489-576-02Drs. DIAPER RASH MAXIMUM STRENGTH45 g in 1 TUBECREAM451
80489-576-03Drs. DIAPER RASH MAXIMUM STRENGTH1 in 1 CARTONCREAM11
80489-576-03Drs. DIAPER RASH MAXIMUM STRENGTH49.6 g in 1 TUBECREAM49.61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80489-576DRS. DIAPER RASH MAXIMUM STRENGTH (ZINC OXIDE) CREAM [OL PHARMA TECH, LLC DRS PHARMACY]1Current NDC, 6 package rows20240417_161ba174-1b13-83cd-e063-6394a90af19c.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
686403dimethicone 1 % / zinc oxide 10 % Topical CreamPSN161ba174-1b13-83cd-e063-6394a90af19c1
686403dimethicone 10 MG/ML / zinc oxide 100 MG/ML Topical CreamSCD161ba174-1b13-83cd-e063-6394a90af19c1
686403dimethicone 1 % / zinc oxide 10 % Topical CreamSY161ba174-1b13-83cd-e063-6394a90af19c1
686403dimethicone 10 MG/ML / ZNO 100 MG/ML Topical CreamSY161ba174-1b13-83cd-e063-6394a90af19c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80489-576-01804890576011 TUBE in 1 CARTON (80489-576-01) / 20 g in 1 TUBE1 tube2022-02-01NoNoCurrent
80489-576-02804890576021 TUBE in 1 CARTON (80489-576-02) / 45 g in 1 TUBE1 tube2022-02-01NoNoCurrent
80489-576-03804890576031 TUBE in 1 CARTON (80489-576-03) / 49.6 g in 1 TUBE1 tube2024-04-13NoNoCurrent