FDA.reportPublic FDA data

Aquaphor Healing Diaper Rash

Product NDC
10356-105
11-digit product format
103560105
Labeler code
10356
Product ID
10356-105_46042ace-e7c0-f97e-e063-6394a90af728
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Beiersdorf Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-30
Substance
ZINC OXIDE
Active strength
15 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
Aquaphor Healing Diaper Rash
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE15 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
245660Internal RxNorm lookup
1663733Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dec07dfc-67a2-46ad-8fab-828488bdba15Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10356-105-02Aquaphor Healing Diaper Rash7 g in 1 PACKETCREAM711
10356-105-10Aquaphor Healing Diaper Rash99 g in 1 TUBECREAM9911
10356-105-23Aquaphor Healing Diaper Rash10 g in 1 TUBECREAM1011
10356-105-29Aquaphor Healing Diaper Rash4 g in 1 TUBECREAM411

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10356-105-10GM - Gram10356-1055f9b85ec-6e41-4266-bf56-ddd45942a50312022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZAQUAPHOR HEALING DIAPER RASH (ZINC OXIDE) CREAM [BEIERSDORF INC]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZAQUAPHOR HEALING DIAPER RASH (ZINC OXIDE) CREAM [BEIERSDORF INC]1
CERESININACTIVE INGREDIENTQ1LS2UJO3AAQUAPHOR HEALING DIAPER RASH (ZINC OXIDE) CREAM [BEIERSDORF INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAQUAPHOR HEALING DIAPER RASH (ZINC OXIDE) CREAM [BEIERSDORF INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AQUAPHOR HEALING DIAPER RASH (ZINC OXIDE) CREAM [BEIERSDORF INC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPAQUAPHOR HEALING DIAPER RASH (ZINC OXIDE) CREAM [BEIERSDORF INC]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZAQUAPHOR HEALING DIAPER RASH (ZINC OXIDE) CREAM [BEIERSDORF INC]1
POLYGLYCERYL-4 ISOSTEARATEINACTIVE INGREDIENT820DPX33S7AQUAPHOR HEALING DIAPER RASH (ZINC OXIDE) CREAM [BEIERSDORF INC]1
WATERINACTIVE INGREDIENT059QF0KO0RAQUAPHOR HEALING DIAPER RASH (ZINC OXIDE) CREAM [BEIERSDORF INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10356-105AQUAPHOR HEALING DIAPER RASH (ZINC OXIDE) CREAM [BEIERSDORF INC]10Current NDC, Legacy NDC, 4 package rows20250101_dec07dfc-67a2-46ad-8fab-828488bdba15.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 46 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLC1ac59efd-9efd-09d9-e063-6394a90a5e402025-01-20WarningsExact identifier
application number: M016
Hand Sanitizer WipesALCOHOLHANUL CO.,LTDa3424b96-74b0-21c4-e053-2a95a90ae7ea2025-01-20WarningsExact identifier
application number: M016
Hand Sanitizer WipesALCOHOLHANUL CO.,LTDa4eb1cad-a9c0-43d3-e053-2995a90a06a02025-01-20WarningsExact identifier
application number: M016
RICO Hand Sanitizer WipesALCOHOLHANUL CO.,LTDdc8ba3a2-9748-ec52-e053-2995a90a638b2025-01-20WarningsExact identifier
application number: M016
Hand SanitizerALCOHOLHANUL CO.,LTDa4fa65f9-9786-76dd-e053-2995a90a6e132025-01-20WarningsExact identifier
application number: M016
SAN Skinlab Cloth Wet WipesBENZALKONIUM CHLORIDE 0.13%HANUL CO.,LTDc058d278-3d6d-7e3c-e053-2995a90a6c2f2025-01-20WarningsExact identifier
application number: M016
Rico Hand SanitizerALCOHOLHANUL CO.,LTDa6065fcd-3968-d5a1-e053-2a95a90ab8d62025-01-20WarningsExact identifier
application number: M016
VITAMIN A and DWHITE PETROLATUMVIVE HEALTH LLC2bd4465b-6e46-51e2-e063-6294a90a695f2025-01-16WarningsExact identifier
application number: M016
VITAMIN A and DWHITE PETROLATUMVIVE HEALTH LLC2bd4a2b0-f586-3ab1-e063-6294a90aa1ed2025-01-16WarningsExact identifier
application number: M016
Dermoia Manuka Honey EczemaOATMEALTREASUREWISE LLC18c174de-6626-45ee-a6aa-f75a48daab8d2025-01-15WarningsExact identifier
application number: M016
AllantoinMEDICINAL MASSAGE OILCarolina Cannabis Creations L.L.C04b5619b-2122-f159-e063-6394a90a2e052025-01-15WarningsExact identifier
application number: M016
Skin Barista 2in1 White Body PerfectionDIMETHICONEPioom Cosmetic Co.,ltd2d7fc20c-31a7-195b-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M016
Skin Barista Rice Bran Cleansing FoamALLANTOINPioom Cosmetic Co.,ltd2d7fc7f6-1e89-116c-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M016
Hammertech Vitamin A and DWHITE PETROLATUMHAMMER TECH LLCffe96aa1-db6b-33e4-e053-6394a90a7e4e2025-01-14WarningsExact identifier
application number: M016
NOON Cartessa Accelerate ProgramALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONENoon Aesthetics M.R. Ltd400ead81-ab07-400f-b261-db330e0fd0042025-01-14WarningsExact identifier
application number: M016
NOON Post Procedure ProgramALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONENoon Aesthetics M.R. Ltd9d1d11b4-40ff-4ea8-a3af-655f457c05f12025-01-14WarningsExact identifier
application number: M016
OLP diaper Rash cream A and DZINC OXIDEOL PHARMA TECH, LLC Drs PHARMACYd6faa4d9-751c-a1b6-e053-2a95a90aee5b2025-01-09WarningsExact identifier
application number: M016
ANTI-ITCHZINC ACETATE , DIPHENHYDRAMINEOL PHARMA TECH, LLCb79d3096-c609-e710-e053-2995a90a8da22025-01-09WarningsExact identifier
application number: M016
ANTIBACTERIAL DREAMY FLORALSGLYCERINQuimicas Handal de Centroamerica SA de CV09f73bec-516d-90f0-e063-6394a90aecab2025-01-08WarningsExact identifier
application number: M016
AOAO Repair Foot CreamUREA,SALICYLIC ACID,TOCOPHEROL,CAMELLIA SINENSIS LEAF EXTRACT,ALOE VERA LEAF EXTRACT,COCOS NUCIFERA (COCONUT) OIL.Guangdong Junhui Biotechnology Co.,LTD21064e84-c827-ca82-e063-6394a90a6c652025-01-08WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1663733Aquaphor Diaper Rash 15 % Topical CreamPSNdec07dfc-67a2-46ad-8fab-828488bdba1511
245660zinc oxide 15 % Topical CreamPSNdec07dfc-67a2-46ad-8fab-828488bdba1511
1663733zinc oxide 150 MG/ML Topical Cream [Aquaphor Diaper Rash]SBDdec07dfc-67a2-46ad-8fab-828488bdba1511
245660zinc oxide 150 MG/ML Topical CreamSCDdec07dfc-67a2-46ad-8fab-828488bdba1511
1663733Aquaphor Diaper Rash 15 % Topical CreamSYdec07dfc-67a2-46ad-8fab-828488bdba1511
1663733Aquaphor Diaper Rash 150 MG/ML Topical CreamSYdec07dfc-67a2-46ad-8fab-828488bdba1511
245660zinc oxide 15 % Topical CreamSYdec07dfc-67a2-46ad-8fab-828488bdba1511
245660ZNO 150 MG/ML Topical CreamSYdec07dfc-67a2-46ad-8fab-828488bdba1511
1663733ZNO 150 MG/ML Topical Cream [Aquaphor Diaper Rash]SYdec07dfc-67a2-46ad-8fab-828488bdba1511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10356-105-02103560105027 g in 1 PACKET (10356-105-02) 7 g2015-01-300000-00-00NoNoCurrent
10356-105-101035601051099 g in 1 TUBE (10356-105-10) 99 g2015-01-300000-00-00NoNoCurrent
10356-105-231035601052310 g in 1 TUBE (10356-105-23) 10 g2015-01-300000-00-00NoNoCurrent
10356-105-29103560105294 g in 1 TUBE (10356-105-29) 4 g2015-01-300000-00-00NoNoCurrent