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 50 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Shea Butter Petroleum JellyPETROLATUM JELLYWalgreense35d913e-2195-4e3d-ae38-f010317140fd2024-12-17WarningsExact identifier
application number: M016
Jell Pharmaceuticals Vitamin A DPETROLATUMJell Pharmaceuticals Pvt. Ltd.6ab8ba54-3679-4fd0-a876-cb89aace96ca2024-12-17WarningsExact identifier
application number: M016
Shea Butter Petroleum JellyPETROLATUM JELLYJell Pharmaceuticals Pvt. Ltd.cd848f33-e863-d3af-e053-2a95a90a45b12024-12-17WarningsExact identifier
application number: M016
Softlips Cherry, Raspberry, VanillaDIMETHICONEThe Mentholatum Companyb7b2f64e-27b4-4c71-95cf-78b37540f9752024-12-17WarningsExact identifier
application number: M016
Softlips Tropical CoconutDIMETHICONEThe Mentholatum Company1203ea70-dc1a-4439-a230-bd3fc45f75f52024-12-17WarningsExact identifier
application number: M016
Softlips Tropical Coconut Peach PassionDIMETHICONEThe Mentholatum Company11f619e7-4a58-45e4-8f4a-fe358832ab642024-12-17WarningsExact identifier
application number: M016
Softlips Watermelon, Tropical Coconut, Peach PassionDIMETHICONEThe Mentholatum Companye9212502-909a-4184-905e-f31a53602c3b2024-12-17WarningsExact identifier
application number: M016
Softlips WatermelonDIMETHICONEThe Mentholatum Companye32d738e-e0af-4f17-a753-bdc7938b16842024-12-17WarningsExact identifier
application number: M016
Softlips Peach PassionDIMETHICONEThe Mentholatum Company4a133e73-e51b-4f04-91de-dc8c4d4dba302024-12-17WarningsExact identifier
application number: M016
Sweet Cheeks DiaperZINC OXIDETubby Todd4ed0afe1-c893-453e-b4d5-f32561360ec12024-12-17WarningsExact identifier
application number: M016
White PetrolatumPETROLATUMGeri-Care Pharmaceuticals, Corpf40a29c2-65ea-91f9-e053-2a95a90ac4392024-12-17WarningsExact identifier
application number: M016
Vitamin A and DPETROLATUMGeri-care Pharmaceutials Corpfd76c101-a287-f92c-e053-6294a90a44682024-12-17WarningsExact identifier
application number: M016
Foster and Thrive Phenolated CalamineCALAMINE AND ZINC OXIDE AND PHENOLStrategic Sourcing Services LLC298171e1-2826-d33b-e063-6394a90a875a2024-12-17WarningsExact identifier
application number: M016
Secura Dimethicone ProtectantDIMETHICONESmith & Nephew Medical Ltd83f92ac9-4114-4192-926d-be2854a841062024-12-16WarningsExact identifier
application number: M016
CVS Maximum Strength Anti-Itch CreamHYDROCORTISONE 1%CVS Healthc2876cba-d7e7-de5c-e053-2a95a90a63552024-12-16WarningsExact identifier
application number: M016
Blistex Medicated Lip Balm Variety Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip)DIMETHICONE, OCTINOXATE, OCTISALATE, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc4121d671-521c-4f36-b2db-652c13f730c62024-12-16WarningsExact identifier
application number: M016
Blistex Medicated Lip Balm Variety Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Mint Lip Balm)DIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc24e1d2fc-3f9d-4e86-a397-61bfbfc4d58c2024-12-16WarningsExact identifier
application number: M016
Balmex Diaper RashZINC OXIDE 11.3%Randob Labs, LTDf7f7a89d-d4e0-9faa-e053-6294a90aaf7b2024-12-15WarningsExact identifier
application number: M016
QC ScarALLANTOIN 0.5%CDMAf7e3d751-a47a-2bca-e053-6394a90a65412024-12-15WarningsExact identifier
application number: M016
Dr. Butler Soothing IncontinencePETROLATUM 36%Beyond Health P.A.d17a0c28-a5b7-4df0-e053-2995a90a8edd2024-12-15WarningsExact 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