FDA.reportPublic FDA data

Zinc Oxide

Product NDC
87236-007
11-digit product format
872360007
Labeler code
87236
Product ID
87236-007_5101e1fe-dffa-1e92-e063-6394a90ae61f
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide 20%
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Aldermed Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-01
Substance
ZINC OXIDE
Active strength
20 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage87236-00787236-007-01DDiscontinued by firm2026-10-15

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
Zinc Oxide
Brand name suffix
Skin Protectant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 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
198911Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e52Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87236-007-01Zinc OxideSkin Protectant1 in 1 CARTONOINTMENT15
87236-007-01Zinc OxideSkin Protectant30 g in 1 TUBEOINTMENT305
87236-007-16Zinc OxideSkin Protectant454 g in 1 JAROINTMENT4545
87236-007-28Zinc OxideSkin Protectant1 in 1 CARTONOINTMENT15
87236-007-28Zinc OxideSkin Protectant28.4 g in 1 TUBEOINTMENT28.45
87236-007-56Zinc OxideSkin Protectant56.6 g in 1 TUBEOINTMENT56.65
87236-007-56Zinc OxideSkin Protectant1 in 1 CARTONOINTMENT15

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 51 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Copperlife FootDIMETHICONE 1%Tommie Copper, Inc.cb825d2c-6333-3c1f-e053-2995a90a78f32024-12-15WarningsExact identifier
application number: M016
Tommie Copper FootDIMETHICONE 1%Tommie Copper, Inc.ca3d3374-a3d4-69e5-e053-2995a90a3ece2024-12-15WarningsExact identifier
application number: M016
Evereden Healing Eczema TreatmentCOLLOIDAL OATMEALEden Brands, Inc.d43f0eaa-aab0-eaff-e053-2995a90ac5c82024-12-13WarningsExact identifier
application number: M016
Babo Fragrance Free Diaper CreamZINC OXIDEBabo Botanicals, Inc.adcd4fc7-c400-fc8e-e053-2a95a90a7e1f2024-12-12WarningsExact identifier
application number: M016
DomeboroALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATEAdvantice Health, LLC.28c39200-2f7c-954b-3ce7-7349b27388122024-12-12WarningsExact identifier
application number: M016
Atopis Eczema Therapy CreamCOLLOIDAL OATMEALBionona Limited8d4b4a14-b631-f2fa-e053-2a95a90a932f2024-12-12WarningsExact identifier
application number: M016
Desitin Daily Defense Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLCb6e0d1a3-e469-4102-916b-d5cc8ca12e732024-12-11WarningsExact identifier
application number: M016
Little Me Multipurpose Baby BalmWHITE PETROLATUMShalom International Corpe09518f1-3691-4d85-a8e1-a5c4520570662024-12-11WarningsExact identifier
application number: M016
Blistex Ivarest Poison Ivy ItchZINC ACETATE AND PRAMOXINE HYDROCHLORIDEBlistex Inc.e1eaa3e7-12ab-4b7b-b1b0-77ab07b76a2a2024-12-11WarningsExact identifier
application number: M016
Deep Renewal Broad SpectrumDIMETHICONE, AVOBENZONE, HOMOSALATE, AND OCTISALATEBlistex Inc11c0e084-dc40-4969-a176-3af4116d6f272024-12-10WarningsExact identifier
application number: M016
BOA VIDA Recovery CremeDIMETHICONECentral Solutions Incbfa07058-7a20-4b9f-bad1-4b9fb5c037e02024-12-09WarningsExact identifier
application number: M016
BOA VIDA CanopyDIMETHICONECentral Solutions Inc44c98a3f-02f1-46ae-9fb0-1eb822b5ceaf2024-12-09WarningsExact identifier
application number: M016
DermaCen Skin ProtectantZINC OXIDECentral Solutions Inc990c3a65-bca5-1f0d-e053-2995a90aa7ae2024-12-09WarningsExact identifier
application number: M016
BOA VIDA CalvidaZINC OXIDECentral Solutions Inc48eb2031-bc80-45d5-b8b3-cc08fcab64f12024-12-09WarningsExact identifier
application number: M016
BOA VIDA CleansingDIMETHICONECentral Solutions Inc0b456b20-ab06-4adf-b5f0-1693d33979df2024-12-09WarningsExact identifier
application number: M016
SOOTHE Sensitive Skin TreatmentALLANTOIN, DIMETHICONERodan & Fields2bd8cac4-5f40-4d04-91f2-3ea8a138033b2024-12-09WarningsExact identifier
application number: M016
Aveeno Eczema Therapy Rescue Relief TreatmentCOLLOIDAL OATMEALKenvue Brands LLCf67e528a-b822-3f7a-e053-2995a90ae7332024-12-06WarningsExact identifier
application number: M016
Humphreys MaravillaWITCH HAZELHumphreys Pharmacal, Incorporated7d403bf4-8a0d-4337-8e81-1149cd0ae1dc2024-12-06WarningsExact identifier
application number: M016
Skin Soothing CreamCOLLOIDAL OATMEALAllure Labs Inc9b1dfb4b-ce35-46a1-bfc6-ee5b871955f32024-12-05WarningsExact identifier
application number: M016
Skin Soothing Cream - Nut FreeCOLLOIDAL OATMEALAllure Labsb5eb48a5-e884-3bf6-e053-2a95a90abb972024-12-05WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198911zinc oxide 20 % Topical OintmentPSNa55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e525
198911zinc oxide 0.2 MG/MG Topical OintmentSCDa55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e525
198911zinc oxide 20 % Topical OintmentSYa55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e525
198911zinc oxide 200 MG per GM Topical OintmentSYa55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e525
198911ZNO 0.2 MG/MG Topical OintmentSYa55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e525

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87236-007-01872360007011 in 1 CARTONHistorical
87236-007-1687236000716454 g in 1 JAR (87236-007-16) 454 g2025-12-01NoNoCurrent
87236-007-28872360007281 TUBE in 1 CARTON (87236-007-28) / 28.4 g in 1 TUBE1 tube2025-12-01NoNoCurrent
87236-007-56872360007561 TUBE in 1 CARTON (87236-007-56) / 56.6 g in 1 TUBE1 tube2025-12-01NoNoCurrent