FDA.reportPublic FDA data

Zinc Oxide

Product NDC
67777-223
11-digit product format
677770223
Labeler code
67777
Product ID
67777-223_4f5b6507-0292-edc3-e063-6294a90a3c79
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide Ointment
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-29
Substance
ZINC OXIDE
Active strength
200 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Zinc Oxide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE200 mg/g

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
11d79dd6-35f7-4399-e063-6294a90ac7ddAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-223-01Zinc Oxide28.4 g in 1 TUBEOINTMENT28.42
67777-223-02Zinc Oxide72 in 1 CASEOINTMENT722
67777-223-03Zinc Oxide56.7 g in 1 TUBEOINTMENT56.72
67777-223-04Zinc Oxide72 in 1 CASEOINTMENT722
67777-223-05Zinc Oxide425 g in 1 JAROINTMENT4252
67777-223-06Zinc Oxide12 in 1 CASEOINTMENT122
67777-223-11Zinc Oxide1 in 1 BOXOINTMENT12
67777-223-13Zinc Oxide1 in 1 BOXOINTMENT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-223-02GM - Gram67777-223a1aba020-1f07-40bb-8d4d-dacb4126d9c912025-02-10
67777-223-04GM - Gram67777-2239b55a253-7da3-4029-ab9a-2dfba1170e1512025-02-10
67777-223-11GM - Gram67777-2235155c86f-1630-4ac9-b36b-9c3b9aaf67f712025-02-10
67777-223-13GM - Gram67777-2238f27eee2-84fa-4b25-8b80-9b847af3237c12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-223ZINC OXIDE (ZINC OXIDE OINTMENT) OINTMENT [DYNAREX CORPORATION]1Current NDC, 8 package rows20240229_11d79dd6-35f7-4399-e063-6294a90ac7dd.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 9 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUPRADERMWHITE PETROLATUM, LANOLINOlen Skin Care Corporation4e7199bd-52c6-48e9-9c78-c84e45412faf2026-06-10WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP509ee758-9d53-220c-e063-6394a90a4bd52026-06-09WarningsExact identifier
application number: M016
BABY BUM DIAPERZINC OXIDECreative Consumer Products, Inc. DBA (Doing Business As) Dionis Goat Milk Skincare53d8a654-aaec-6f91-e063-6394a90a73512026-06-09WarningsExact identifier
application number: M016
CELISTAR MICRONEEDLING INFUSIONHYALURONATE SODIUMGuangdong Outeli Biotechnology Co., Ltd.53de46a7-3947-70a7-e063-6294a90ab8292026-06-09WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP3c448cf7-8ca5-c7f7-e063-6294a90a75ff2026-06-08WarningsExact identifier
application number: M016
WOODSLEEP Wild Yam CreamGLYCERINShantou Woodsleep Biotechnology Co., Ltd.53b992fd-5759-57bb-e063-6394a90a16002026-06-08WarningsExact identifier
application number: M016
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
application number: M016
GNP Calamine Topical SuspensionCALAMINE 8% AND ZINC OXIDE 8%Amerisource Bergen777b0e66-1bce-4483-9dad-c46796fd6f232026-06-04WarningsExact identifier
application number: M016
GNP CaldyphenCALAMINE AND PRAMOXINE HYDROCHLORIDEAmerisource Bergen515c58d7-0dc4-45e7-9155-e5270a16290e2026-06-04WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company535a0e8e-6bb4-6652-e063-6394a90aa7ff2026-06-03WarningsExact identifier
application number: M016
Quad WashDIMETHICONEDynarex Corporation535dc862-6a18-26c9-e063-6294a90a3d4a2026-06-03WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALJCS Global Distribution, Inc.535e42a1-8b14-324d-e063-6394a90a3f652026-06-03WarningsExact identifier
application number: M016
Petroleum Jelly Skin ProtectantWHITE PETROLATUMAcme United Corporation535e94bb-21e8-90be-e063-6394a90a37bb2026-06-03WarningsExact identifier
application number: M016
ADVANCED HEALINGPETROLATUMRejoice International Corp.532c7e5a-4d05-3bd0-e063-6294a90aee002026-06-01WarningsExact identifier
application number: M016
PUTRIZEN 40 UREAGLYCERINShantou Ximonth Biotechnology Co., Ltd.533dadbc-6f20-d880-e063-6394a90a753f2026-06-01WarningsExact identifier
application number: M016
ADVANCED HEALING BALMPETROLATUMRejoice International Corp.53285d82-3755-ca78-e063-6394a90a50192026-05-31WarningsExact identifier
application number: M016
KIEHLS SINCE 1851 Ultra Facial Meltdown RecoveryCOLLOIDAL OATMEALLOreal USA Products Inc22e088b9-b3b1-4c34-be12-a5a31200ec252026-05-29WarningsExact identifier
application number: M016
Acne Relief CreamNIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOTGuangzhou Senmai Biotechnology Co.,Ltd.53008b89-89ab-7650-e063-6294a90ac16c2026-05-29WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED52efd466-49bd-bbdf-e063-6394a90aa1082026-05-28WarningsExact identifier
application number: M016
TheraCare Vitamin A and D plus EPETROLATUMVeridian Healthcare52e0e248-6c04-feb9-e063-6394a90add462026-05-28WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198911zinc oxide 20 % Topical OintmentPSN11d79dd6-35f7-4399-e063-6294a90ac7dd2
198911zinc oxide 0.2 MG/MG Topical OintmentSCD11d79dd6-35f7-4399-e063-6294a90ac7dd2
198911zinc oxide 20 % Topical OintmentSY11d79dd6-35f7-4399-e063-6294a90ac7dd2
198911zinc oxide 200 MG per GM Topical OintmentSY11d79dd6-35f7-4399-e063-6294a90ac7dd2
198911ZNO 0.2 MG/MG Topical OintmentSY11d79dd6-35f7-4399-e063-6294a90ac7dd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67777-223-016777702230128.4 g in 1 TUBE28.4 gHistorical
67777-223-026777702230272 BOX in 1 CASE (67777-223-02) / 1 TUBE in 1 BOX (67777-223-11) / 28.4 g in 1 TUBE (67777-223-01) 72 box2024-02-29NoNoCurrent
67777-223-036777702230356.7 g in 1 TUBE56.7 gHistorical
67777-223-046777702230472 BOX in 1 CASE (67777-223-04) / 1 TUBE in 1 BOX (67777-223-13) / 56.7 g in 1 TUBE (67777-223-03) 72 box2024-02-29NoNoCurrent
67777-223-0567777022305425 g in 1 JAR425 gHistorical
67777-223-066777702230612 JAR in 1 CASE (67777-223-06) / 425 g in 1 JAR (67777-223-05) 12 jar2024-02-29NoNoCurrent
67777-223-11677770223111 in 1 BOXHistorical
67777-223-13677770223131 in 1 BOXHistorical