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 52 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PETROLEUM jellyPETROLATUMUniversal Distribution Center LLCeaaf95d7-df80-407e-b784-4e42a89d64e52024-12-04WarningsExact identifier
application number: M016
UNIVERSAL COCOA BUTTER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCec688073-6577-6cf9-e053-2a95a90a631d2024-12-04WarningsExact identifier
application number: M016
Burts Bees Rapid Rescue Cold Sore TreatmentCAMPHOR, GLYCERINBurts Bees9f89735d-205f-4d3e-a1e1-ecc96284fe982024-12-03WarningsExact identifier
application number: M016
Mustela Diaper Rash SprayableZINC OXIDEExpanscience Laboratories d/b/a Mustelad9a2aaf6-ab71-97a3-e053-2a95a90a34982024-12-02WarningsExact identifier
application number: M016
Mustela Stelatopia Intense Eczema Relief Skin ProtectantCOLLOIDAL OATMEALExpanscience Laboratories d/b/a Mustelae9ac358e-c9bd-7091-e053-2a95a90a46092024-12-02WarningsExact identifier
application number: M016
ZINC OXIDEZINC OXIDEVIVE HEALTH LLC284dbf6a-6fa2-742b-e063-6394a90afdfd2024-12-02WarningsExact identifier
application number: M016
Readyflush Protect Wipes Fragrance FreeDIMETHICONEMedline Industries, LP743d21bd-c40a-4415-ad97-0d8aa99a8af72024-12-02WarningsExact identifier
application number: M016
Orajel Cold Sore MoisturelockBENZOCAINEChurch & Dwight Co., Inc.3761c7b3-053b-0f50-e054-00144ff88e882024-11-26WarningsExact identifier
application number: M016
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLCed08b690-f907-6d2f-e053-2a95a90af51c2024-11-25WarningsExact identifier
application number: M016
Johnsons First Touch Baby Gift SetZINC OXIDEKenvue Brands LLCda5469ea-3330-4f04-e053-2a95a90aff412024-11-25WarningsExact identifier
application number: M016
Lil Drug Store Petroleum JellyPETROLATUMLil Drug Store Products, Inca8a56786-20c3-43c1-a4db-8502ff08e4cb2024-11-25WarningsExact identifier
application number: M016
TerrasilMed ONCALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsf0cc9448-c531-4dd1-8f5c-5310e4abe1a92024-11-25WarningsExact identifier
application number: M016
TN Dickinsons Witch Hazel AstringentWITCH HAZELDickinson Brands Inc.a9596cf1-8204-447d-90f6-622bf497a7e02024-11-25WarningsExact identifier
application number: M016
PINXAV DAIPER RASHZINC OXIDEEmjay Laboratories Inc.14daf592-8edf-4679-9abf-de1b9d0799ff2024-11-21WarningsExact identifier
application number: M016
Target Maximum Strength Zinc Oxide Diaper RashZINC OXIDE DIAPER RASHTarget Corporation6ba2761c-4c05-498b-a012-e95843c205732024-11-21WarningsExact identifier
application number: M016
Target Baby HealingPETROLATUMTarget Corporation5a445a96-1652-47e0-b9bb-6e63fc1841082024-11-21WarningsExact identifier
application number: M016
Target Vitamin A and D Diaper RashVITAMIN A AND D OINTMENTTarget Corporation6a98e4b9-2906-4207-83ac-48f41fba190e2024-11-21WarningsExact identifier
application number: M016
Walgreens Baby HealingPETROLATUMWalgreens Company54100d5a-7ae1-45ec-94c4-e165b55a6c492024-11-20WarningsExact identifier
application number: M016
Baby Petroleum JellyWHITE PETROLATUM JELLYWALGREENS2008da4f-3c3c-4311-e063-6394a90a81e72024-11-20WarningsExact identifier
application number: M016
Vitamins A and D Without LanolinSKIN PROTECTANTDynarex Corporation822db5f4-d662-0689-e053-2a91aa0ace7e2024-11-20WarningsExact 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