FDA.reportPublic FDA data

Dr. Maxs Diaper

Product NDC
85453-101
11-digit product format
854530101
Labeler code
85453
Product ID
85453-101_31bfa962-5e3c-c5d2-e063-6294a90ac177
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Dr. Max�s LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-04
Substance
ZINC OXIDE
Active strength
12 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Dr. Maxs Diaper
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE12 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199852Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
31bfa962-5e3b-c5d2-e063-6294a90ac177Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85453-101-11Dr. Maxs Diaper94 g in 1 CYLINDEROINTMENT941

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85453-101DR. MAXS DIAPER (ZINC OXIDE) OINTMENT [DR. MAX’S LLC]1Current NDC, 1 package rows20250406_31bfa962-5e3b-c5d2-e063-6294a90ac177.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 60 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THERA Calazinc Body ShieldZINC OXIDEMcKesson Medical-Surgical Inc.974b1046-83ee-4207-91d3-40982beb9c632024-06-17WarningsExact identifier
application number: M016
DimethiconeBODY CLEANSERMcKesson8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a82024-06-14WarningsExact identifier
application number: M016
Dr. Mom Butt BalmDIMETHICONE PETROLATUMFerndale Laboratories, Inc.ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd2024-06-13WarningsExact identifier
application number: M016
Secura ProtectivePETROLATUMSmith & Nephew Medical Ltd20906566-fbf2-46d9-a5d8-c7f7356d10802024-06-12WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
application number: M016
CVS Health Vitamin A and D Skin ProtectantLANOLIN AND PETROLATUMCVS Healthfe3ccabb-9644-4091-9dca-ffd96a43ecaf2024-05-28WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper RashZINC OXIDEBabo Botanicals, Inc.186a9642-cd73-adfb-e063-6394a90a75c72024-05-14WarningsExact identifier
application number: M016
Honest Eczema BalmCOLLOIDAL OATMEALThe Honest Company, Inc.35b8bc5c-420e-4d31-9659-f36cabbd897a2024-05-14WarningsExact identifier
application number: M016
Extra Strength Itch StoppingITCH STOPPING CREAMUniversal Distribution Centre LLCb9a42aa3-1903-76f0-e053-2a95a90a51d12024-05-13WarningsExact identifier
application number: M016
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONCardinal Health, 110 dba Leader7f733c0a-82b2-d3b0-e053-2991aa0a6b0f2024-05-13WarningsExact identifier
application number: M016
Walgreens Maximum Diaper RashZINC OXIDEWalgreens Company5eb2152f-6fa2-4191-878a-207416e698182024-05-07WarningsExact identifier
application number: M016
Cetaphil Eczema Rapid Relief CreamCOLLOIDAL OATMEALGalderma Laboratories, L.P.02a405fa-8ae9-41e9-b86f-ef5fb6e3844a2024-05-02WarningsExact identifier
application number: M016
ChapstickAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC0e34fc74-772e-48fd-a353-58807ef412c12024-05-01WarningsExact identifier
application number: M016
Diaper Rash Cream 40% ZINCZINC OXIDEASTONEA LABS PRIVATE LIMITED16da985a-6210-ec82-e063-6294a90a132d2024-04-24WarningsExact identifier
application number: M016
Petrolatum JellyPETROLATUMASTONEA LABS PRIVATE LIMITED16dac8e5-aeb8-592d-e063-6394a90ae2b62024-04-24WarningsExact identifier
application number: M016
Monistat Complete Care Chafing ReliefDIMETHICONEInsight Pharmaceuticals LLC07d7c883-1fa3-4786-905c-a1fab649765e2024-04-19WarningsExact identifier
application number: M016
zinc oxide 20%ZINC OXIDE 20%Bionpharma Inc1549500a-0941-0fba-e063-6394a90a564e2024-04-18WarningsExact identifier
application number: M016
ARC Skin ProtectantALLANTOINAnjon Biologics, Incf4ff79dd-cb38-4cca-9631-a2758a1718732024-04-18WarningsExact identifier
application number: M016
ZinctralZINC OXIDEPureTek Corporationde990834-00da-0c7a-e053-2995a90a7c372024-04-15WarningsExact identifier
application number: M016
Chapstick Moisturizer Variety PackAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLCbfb9a2d5-1ad2-45b8-a215-9d1370af53372024-04-12WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199852zinc oxide 12 % Topical OintmentPSN31bfa962-5e3b-c5d2-e063-6294a90ac1771
199852zinc oxide 0.12 MG/MG Topical OintmentSCD31bfa962-5e3b-c5d2-e063-6294a90ac1771
199852ZNO 0.12 MG/MG Topical OintmentSY31bfa962-5e3b-c5d2-e063-6294a90ac1771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85453-101-118545301011194 g in 1 CYLINDER (85453-101-11) 94 g2025-04-04NoNoCurrent