FDA.reportPublic FDA data

Diaper Rash

Product NDC
87236-018
11-digit product format
872360018
Labeler code
87236
Product ID
87236-018_516cb310-3e44-00f5-e063-6294a90a4b8c
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Aldermed Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-01
Substance
ZINC OXIDE
Active strength
40 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
Diaper Rash
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE40 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
244638Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4aa79292-dc91-b538-e063-6294a90ac3f0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87236-018-04Diaper Rash113 g in 1 TUBEOINTMENT1132

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 34 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ODLUMIVIE Salmon DNA Repairing SerumRH-OLIGOPEPTIDE-1ODLUMIVIE435ecb5b-0d12-4da1-e063-6394a90a8be22025-11-11WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMKROGER3feb1346-76b6-fbb6-e063-6394a90a17d12025-11-11WarningsExact identifier
application number: M016
ODLUMIVIE Ceramide ReviCell CreamCERAMIDE NPODLUMIVIE435ee48f-1b9e-6d08-e063-6394a90af5b52025-11-11WarningsExact identifier
application number: M016
ODLUMIVIE Dendrobium Restorative MaskDENDROBIUM OFFICINALE STEMODLUMIVIE435ef0e0-50be-c4e4-e063-6294a90a8e8e2025-11-11WarningsExact identifier
application number: M016
Au Kah Chuen FugicalCALAMINE AND DIPHENHYDRAMINE HYDROCHLORIDZhejiang Dingtai Pharmaceutical Co., Ltd5b4add17-6c3d-4093-826a-2edb41c1d1db2025-11-10WarningsExact identifier
application number: M016
TATWAX VITAMINS ADPETROLATUMNantong Health & Beyond Hygienic Products Inc.333fdce4-5a1d-45a4-94fe-81d47ecd26702025-11-07WarningsExact identifier
application number: M016
Arme Scar GelDIMETHICONENanjing Ludejin Corporation Management Co., Ltd42e9a59a-480e-f74a-e063-6294a90a06402025-11-06WarningsExact identifier
application number: M016
Baby Diaper Rash CreamZINC OXIDEHello Bello42f14aa6-5694-7727-e063-6294a90a09f32025-11-06WarningsExact identifier
application number: M016
Atti amour Rose Anti-Aging Repair Classic EssenceNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1e874ac0-a993-be9e-e063-6394a90af4242025-11-06WarningsExact identifier
application number: M016
Atti amour Rose Anti-Aging Repair Eye CreamNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eeb9c36-5bd8-ec90-e063-6294a90ae4e12025-11-06WarningsExact identifier
application number: M016
Atti amour Rose Anti-Aging Repair SerumNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eb08f86-eb2a-7f29-e063-6294a90a05162025-11-06WarningsExact identifier
application number: M016
Atti amour Rose Anti-Aging Repair Moisturizing CreamNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eec4cfe-d5a3-3570-e063-6294a90ac38b2025-11-06WarningsExact identifier
application number: M016
Spa Dry Heel Foot ReliefDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.ab8a70f5-1b3e-48a4-a9f7-ebcb30d527a92025-11-05WarningsExact identifier
application number: M016
Royal Jelly Berry Powerful Lip CareDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.09323fbe-76b5-48c6-80a7-c35b64110a7d2025-11-05WarningsExact identifier
application number: M016
Pink Eczema CreamCOLLOIDAL OATMEALMOOGOO SKIN CARE PTY LTD3b8d92d0-ab7f-8dd5-e063-6394a90aa3af2025-11-04WarningsExact identifier
application number: M016
MedlineZINC OXIDE, PETROLATUMMedline Industries, LPf162b1a8-65b3-13a8-e053-2a95a90a3f132025-11-04WarningsExact identifier
application number: M016
MedlinePETROLATUMMedline Industries, LPf3062b61-e4c4-9f57-e053-2995a90aa0282025-11-04WarningsExact identifier
application number: M016
Sandra Plasencia Dendrobium Officinale Soothing Biofermented MaskTITANIUM DIOXIDEGuangzhou Meijiao Medical Biotechnology Co., Ltd.3cdf06f2-63f2-7a59-e063-6294a90a72ea2025-11-03WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELPremier Brands of America Inc.38583c02-497b-922c-e063-6294a90a49de2025-11-03WarningsExact identifier
application number: M016
The Zoeun Omega SerumCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.4277da80-b55b-74af-e063-6394a90af3252025-10-31WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
244638zinc oxide 40 % Topical OintmentPSN4aa79292-dc91-b538-e063-6294a90ac3f02
244638zinc oxide 0.4 MG/MG Topical OintmentSCD4aa79292-dc91-b538-e063-6294a90ac3f02
244638zinc oxide 40 % Topical OintmentSY4aa79292-dc91-b538-e063-6294a90ac3f02
244638ZNO 0.4 MG/MG Topical OintmentSY4aa79292-dc91-b538-e063-6294a90ac3f02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87236-018-0487236001804113 g in 1 TUBE (87236-018-04) 113 g2025-12-01NoNoCurrent