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 19 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineFERRIC OXIDE REDPerrigo Direct, Inc256bd1d4-fd50-408f-9aee-84f218bb49712026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMPerrigo Direct, Ince11470b2-80d6-4008-b87e-eb6aeadfce742026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATEPerrigo Direct, Inccc0378f2-6d5f-47ec-b16a-64668b4c29cc2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXIND HCLPerrigo Direct, Inc54a20ec9-ab86-4410-af94-e04393e9d4b32026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Vitamin A DLANOLIN, PETROLATUMMeijer, Inc.adc3bb9b-ed8a-4b65-b44c-1d1e978c89ec2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEMeijer, Inc.1b72f927-c2ae-4190-a035-5d7bb9f53c152026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMMeijer, Inc.af293cc0-ccd5-42a6-861b-c19fa6ffd06a2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Healing for BabiesPETROLATUMMeijer, Inc.09878fe0-0890-4af3-a3f6-d2890041e9f82026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATEMeijer, Inc.fa8ae34c-7b68-454f-8a3b-0eaa93a340922026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Baby Diaper RashZINC OXIDEMeijer, Inc.04bec667-a11e-42d2-a4b3-1416eebf1e8d2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
HealingPETROLATUMMeijer, Inc.8cb56ee4-b9d1-4a29-88c7-e6f3ac2112c12026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLMeijer, Inc.6b369ef2-fd54-4931-a9eb-0fb42834c2ef2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
DimethiconeDIMETHICONEMeijer, Inc.75b91b97-ea84-4c4d-9e58-5a9ff27a778c2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALMeijer, Inc.d36a7479-7b3b-49fe-8144-b5cce0e173fb2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDAILY MOISTURIZINGMeijer, Inc.44949b46-70f2-4e52-adba-a8455da614eb2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELMeijer, Inc.13e4aece-5b91-4f89-a912-540bf170a8d12026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDETarget Corporation7fb5f9ca-cd90-4933-9fe8-907ece00458b2026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDTarget Corporationd4ee05c8-ae62-45df-8783-1ed57fa030ec2026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMTarget Corporation5237c7f2-7135-4558-a758-4fc2a232172f2026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMTarget Corporation3e620e4f-9e29-9e39-e063-6394a90adeda2026-02-18Warnings, 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