FDA.reportPublic FDA data

Sprayable Diaper Rash Cream

Product NDC
69366-509
11-digit product format
693660509
Labeler code
69366
Product ID
69366-509_46430259-9b4c-a7e5-e063-6394a90aca71
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
SPRAY
Route
TOPICAL
Labeler
The Honest Company, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-06
Substance
ZINC OXIDE
Active strength
10 g/100mL
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
Sprayable Diaper Rash Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE10 g/100mL

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
1232104Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e0f28717-a87a-2759-e053-2995a90abe7aAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69366-509-042023-12-19C16284748780-10191ceaa-6f51-198a-e063-dbdaa90aec3eSprayable Diaper Rash Cream
69366-509-042023-07-28C16284748780-10191ceaa-6f51-198a-e063-dbdaa90aec3eSprayable Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69366-509-04Sprayable Diaper Rash Cream59 mL in 1 BOTTLE, SPRAYSPRAY594

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69366-509SPRAYABLE DIAPER RASH CREAM (ZINC OXIDE) SPRAY [THE HONEST COMPANY, INC.]3Current NDC, Legacy NDC, 1 package rows20231220_e0f28717-a87a-2759-e053-2995a90abe7a.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 49 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Savvy Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE ZINC ACETATESavvy Care and Cosmetics05ee2662-6a51-6e49-e063-6294a90a4ed72024-12-19WarningsExact identifier
application number: M016
Health Smart Lavender Baby PetroleumWHITE PETROLEUMHome Smart Products5828df37-2a42-4129-8e4e-d5ac9c4c96152024-12-19WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMRejoice International Inc.980d030a-feaf-4a81-865e-f85c661513802024-12-19WarningsExact identifier
application number: M016
Baby Petroleum JellyWHITE PETROLATUMRejoice International Inc.caf568aa-3889-41ff-835e-875bb6d9ca792024-12-19WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMRejoice International Inc.a45eb8aa-9fc9-4332-a3ef-0e6fd348fb952024-12-19WarningsExact identifier
application number: M016
Cars PetroleumWHITE PETROLATUMUltra Distributors Inc.9905b5a4-382e-4d2a-b971-37998c14c3302024-12-19WarningsExact identifier
application number: M016
Health Smart Aloe Vera PetroleumWHITE PETROLEUMHome Smart Products2671f2ed-af9d-4234-95bf-def368242a782024-12-19WarningsExact identifier
application number: M016
DCH ScarALLANTOIN 0.5%Derma Care Research Labs, LLC00edbc64-9d32-5751-e063-6294a90a400b2024-12-19WarningsExact identifier
application number: M016
Bamboobies Diaper RashZINC OXIDE 15%Derma Care Research Labs, LLC0411f5e3-03d2-c512-e063-6394a90a37d32024-12-19WarningsExact identifier
application number: M016
Maximum Strength Medicated Foot PowderMEDICATED FOOT POWDERJell Pharmaceuticals Pvt. Ltd.cdaae985-5363-e9d2-e053-2995a90a26822024-12-18WarningsExact identifier
application number: M016
BABY FRESH SCENT PETROLEUMWHITE PETROLEUMJell Pharmaceuticals Pvt Ltd.d80d21cf-9463-7184-e053-2995a90a23f32024-12-18WarningsExact identifier
application number: M016
Health Smart Baby PetroleumWHITE PETROLEUMHome Smart Productsedd9d018-c2c9-4a9a-b727-0a92cd463c022024-12-18WarningsExact identifier
application number: M016
Health Smart Cocoa Butter PetroleumWHITE PETROLEUMHome Smart Productsa65c8267-d34f-4542-a7ca-5180e860a03d2024-12-18WarningsExact identifier
application number: M016
Princess PetroleumWHITE PETROLATUMUltra Distributors Inc.6d9c92bf-9263-40a4-acac-5c3f0b08c69d2024-12-18WarningsExact identifier
application number: M016
Meijer Petroleum JellyWHITE PETROLATUMMeijer Distribution, Incb299cf2a-2c6a-68f4-e053-2995a90a5bd72024-12-18WarningsExact identifier
application number: M016
Foster and Thrive CaldyphenCALAMINE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services, LLC29945734-4ea6-b702-e063-6294a90ae6f22024-12-18WarningsExact identifier
application number: M016
Foster and Thrive Caldyphen ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEStrategic Sourcing Services, LLC29946912-9794-8a8e-e063-6394a90a279e2024-12-18WarningsExact identifier
application number: M016
Caring Mills Petroleum JellyWHITE PETROLATUMVeridian Healthcarefbbfa780-0e2b-1874-e053-6394a90a5eeb2024-12-18WarningsExact identifier
application number: M016
Serawise Eczema RescueOATMEALDrAnaMaria.com LLCe805866a-2349-4b86-bc83-a7c859cb94032024-12-18WarningsExact identifier
application number: M016
TheraCare Petroleum JellyWHITE PETROLATUMVeridian Healthcared6fad49b-8a49-7f7c-e053-2a95a90ae6382024-12-18WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1232104zinc oxide 10 % Topical SprayPSNe0f28717-a87a-2759-e053-2995a90abe7a4
1232104zinc oxide 100 MG/ML Topical SpraySCDe0f28717-a87a-2759-e053-2995a90abe7a4
1232104zinc oxide 10 % Topical SpraySYe0f28717-a87a-2759-e053-2995a90abe7a4
1232104ZNO 100 MG/ML Topical SpraySYe0f28717-a87a-2759-e053-2995a90abe7a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69366-509-046936605090459 mL in 1 BOTTLE, SPRAY (69366-509-04) 59 ml2022-06-060000-00-00NoNoCurrent