FDA.reportPublic FDA data

DiaperRashOintment

Product NDC
68016-128
11-digit product format
680160128
Labeler code
68016
Product ID
68016-128_29b767b1-aee6-2365-e063-6294a90a6778
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Pharmacy Value Alliance, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-08-22
Substance
ZINC OXIDE
Active strength
40 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68016-128-20fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68016-128-2086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68016-128-20bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68016-128-208dfbde2a14a4…c9ff85d89658…

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
DiaperRashOintment
Listing expiration
2026-12-31

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
3aace6d8-d24c-00e1-e054-00144ff8d46cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-128-202023-05-08C16284748780-1ba0f9c33-2345-a910-e053-dadaa90a0b85Diaper Rash Ointment
68016-128-202021-01-29C16284748780-1ba0f9c33-2345-a910-e053-dadaa90a0b85Diaper Rash Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-128-20DiaperRashOintment113 g in 1 TUBEOINTMENT1137

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-128DIAPERRASHOINTMENT (ZINC OXIDE) OINTMENT [PHARMACY VALUE ALLIANCE, LLC]7Current NDC, Legacy NDC, 1 package rows20241222_3aace6d8-d24c-00e1-e054-00144ff8d46c.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
244638zinc oxide 40 % Topical OintmentPSN3aace6d8-d24c-00e1-e054-00144ff8d46c7
244638zinc oxide 0.4 MG/MG Topical OintmentSCD3aace6d8-d24c-00e1-e054-00144ff8d46c7
244638zinc oxide 40 % Topical OintmentSY3aace6d8-d24c-00e1-e054-00144ff8d46c7
244638ZNO 0.4 MG/MG Topical OintmentSY3aace6d8-d24c-00e1-e054-00144ff8d46c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68016-128-2068016012820113 g in 1 TUBE (68016-128-20) 113 g2018-02-28NoNoCurrent