Diaper Rash Cream 2.5oz

Product NDC
57337-151
11-digit product format
573370151
Labeler code
57337
Product ID
57337-151_0ba98cdf-489f-dc2a-e063-6294a90adb38
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Rejoice International Corp.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-04
Substance
ZINC OXIDE
Active strength
.4 g/g
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 Cream 2.5oz
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE.4 g/g

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
1305337Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0ba98cdf-489e-dc2a-e063-6294a90adb38Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-151-01Diaper Rash Cream 2.5oz71 g in 1 TUBECREAM711
57337-151-01Diaper Rash Cream 2.5oz1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-151DIAPER RASH CREAM 2.5OZ (ZINC OXIDE) CREAM [REJOICE INTERNATIONAL CORP.]1Current NDC, 2 package rows20231204_0ba98cdf-489e-dc2a-e063-6294a90adb38.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 25 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kenkoderm Eczema Honey Soothing BodyKENKODERM ECZEMA HONEY SOOTHING BODY LOTIONGuangzhou Ariel Biotech Co., Ltd.4865c697-05fc-eac8-e063-6294a90ae5412026-01-14WarningsExact identifier
application number: M016
Gold Bond Medicated eczema reliefCOLLOIDAL OATMEALChattem, Inc.52744c77-278f-40b1-a356-14ae4366389b2026-01-14WarningsExact identifier
application number: M016
Water Drench Hyaluronic Healing BalmDIMETHICONEPeter Thomas Roth Labs, LLC3f789176-1d80-d146-e063-6294a90a948a2026-01-13WarningsExact identifier
application number: M016
DERMEDIAL Anti-ItchOATMEAL, ZINC OXIDESaje Natural Business Inc385dd757-740b-8324-e063-6294a90afeee2026-01-13WarningsExact identifier
application number: M016
Sweet cheeksZINC OXIDESaje Natural Business Inc.5fc6486e-8604-5c7b-e053-2991aa0a8d142026-01-13WarningsExact identifier
application number: M016
TeevodarALLANTOINPEER PHARM LTD.57a1b6d1-9439-462b-aeb9-ef806e572eaf2026-01-12WarningsExact identifier
application number: M016
Botao Baby Diaper Rash CreamZINC OXIDEPeer Pharm Ltd.df60a70e-e6c0-41b3-e053-2995a90af1762026-01-12WarningsExact identifier
application number: M016
ECZEMA HAND RELIEFCOLLOIDAL OATMEALSkinfix, Inc.0389bab7-04fb-7cfc-e063-6394a90a22d82026-01-12WarningsExact identifier
application number: M016
SKINFIX HAND REPAIROATMEALSkinfix, Inc.1b65fc81-1b9e-4260-829a-332cf6891d022026-01-12WarningsExact identifier
application number: M016
ECZEMA INTENSIVE DAILY RELIEF BODYCOLLOIDAL OATMEAL CREAMSkinfix, Inc.0be3c631-bc9b-00a9-e063-6394a90abcbb2026-01-12WarningsExact identifier
application number: M016
SarnaCOLLOIDAL OATMEALCrown Laboratories, Inc.2d6b1872-9f4d-9eb3-e063-6394a90ab6752026-01-12WarningsExact identifier
application number: M016
XIMONTH Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.47f1a711-5d6f-c023-e063-6294a90aa8012026-01-09WarningsExact identifier
application number: M016
Endit zinc oxide skin protectionZINC OXIDEEndIt Laboratories, Inc.e60bb0da-3349-f8f9-e053-2a95a90a90512026-01-09WarningsExact identifier
application number: M016
Endit Zinc Oxide Skin ProtectantZINC OXIDEEndit Laboratories, Inc.55b3aa07-871d-421b-b76a-c2d359d6003f2026-01-09WarningsExact identifier
application number: M016
Flanders ButtocksWHITE PETROLATUM, ZINC OXIDEFlanders Inc32371159-c76d-41b0-e054-00144ff88e882026-01-09WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMMY IMPORTS USA LLC47da77ea-ab4e-fc3c-e063-6394a90a27b72026-01-08WarningsExact identifier
application number: M016
Z-BumDIAPER RASH CREAMGM Pharmaceuticals, Inc2a36f396-3a30-3f3f-e054-00144ff8d46c2026-01-08WarningsExact identifier
application number: M016
Daily VLotionDIMETHICONEKindra1cc4b804-6483-68fd-e063-6294a90a38e42026-01-08WarningsExact identifier
application number: M016
V Relief SerumDIMETHICONEKindra1cd8a9e9-ac88-1799-e063-6294a90a32782026-01-08WarningsExact identifier
application number: M016
DR SMITHS DIAPERZINC OXIDEMission Pharmacal7705b182-acf7-4195-9996-7d9fcdfbf0552026-01-08WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305337zinc oxide 40 % Topical CreamPSN0ba98cdf-489e-dc2a-e063-6294a90adb381
1305337zinc oxide 400 MG/ML Topical CreamSCD0ba98cdf-489e-dc2a-e063-6294a90adb381
1305337zinc oxide 40 % Topical CreamSY0ba98cdf-489e-dc2a-e063-6294a90adb381
1305337ZNO 400 MG/ML Topical CreamSY0ba98cdf-489e-dc2a-e063-6294a90adb381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57337-151-01573370151011 TUBE in 1 BOX (57337-151-01) / 71 g in 1 TUBE1 tube2023-12-04NoNoCurrent