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 59 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vitamin A and DVITAMIN A AND DMIDWOOD BRANDS, LLC1d0ebe9a-cbc5-1765-e063-6294a90aa4762024-07-18WarningsExact identifier
application number: M016
Kidgets Baby Petroleum JellyBABY PETROLEUM JELLYMIDWOOD BRANDS, LLC.1d0eb8be-13b7-c466-e063-6294a90a93b92024-07-11WarningsExact identifier
application number: M016
IvarestZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDEBlistex Inc6f68cbbb-6269-4bb3-8cc9-50b146703b422024-07-09WarningsExact identifier
application number: M016
Best Choice Diaper RashZINC OXIDETrifecta Pharmaceuticals USA LLC1be37841-e0a8-a0de-e063-6294a90a9eb12024-06-27WarningsExact identifier
application number: M016
Gas Relief Ultra StrengthSIMETHICONEWalgreens00a9164a-1817-4130-9c7f-9f5833c9690f2024-06-26WarningsExact identifier
application number: M016
Astonea Skin ProtectantZINC OXIDEASTONEA LABS PRIVATE LIMITEDe3c7a515-3e77-da85-e053-2995a90a3ee12024-06-25WarningsExact identifier
application number: M016
Astonea Vitamin A and DWHITE PETROLATUMASTONEA LABS PRIVATE LIMITEDef7c357b-5ff6-b9d7-e053-2a95a90a1dcf2024-06-25WarningsExact identifier
application number: M016
ZOEY NATURALS DIAPER CreamZINC OXIDEAbsolutely Natural70fac4d6-8833-4799-b6b6-796f8f13f80e2024-06-25WarningsExact identifier
application number: M016
Medicated BodyMENTHOL AND ZINC OXIDEUniversal Distribution Center LLC2a59a847-cc7a-42cf-b49a-92e7254c16292024-06-19WarningsExact identifier
application number: M016
THERA Moisturizing Body ShieldDIMETHICONEMcKesson Medical-Surgical Inc.56869b64-11ee-4df6-8102-ce5818e0116e2024-06-18WarningsExact identifier
application number: M016
DimethiconeSKIN PROTECTANTMcKesson96886b33-44d4-5a2a-e053-2a95a90a505e2024-06-18WarningsExact identifier
application number: M016
Derma E Eczema ReliefOATMEALderma e767c4a76-8ccb-4530-9b4b-a7ea1a596c7f2024-06-18WarningsExact identifier
application number: M016
Insect sting relief pad 01SODIUM BICARBONATECosmuses Cosmetics (Ningbo) Co., Ltd.1b0f0088-6482-6de7-e063-6294a90aeeb72024-06-17WarningsExact identifier
application number: M016
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

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