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 4 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petroleum Jelly, Lil Drug StorePETROLATUM JELLYLil' Drug Store Products, Inc.5862af40-97e2-d792-e063-6394a90a0f1a2026-08-06WarningsExact identifier
application number: M016
AOAO RAPID ACNE RELIEFSALICYLIC ACID,BENZOYL PEROXIDEGuangzhou Senmai Biotechnology Co.,Ltd.586df874-0f71-ed46-e063-6294a90a0a8e2026-08-06WarningsExact identifier
application number: M016
Dealmed Vitamins A and DWHITE PETROLATUMDealmed Medical Supplies, LLC.d6584809-b438-4b2c-ab37-522e0dbef4702026-08-05WarningsExact identifier
application number: M016
Dealmed Vitamins A and DPETROLATUMDealmed Medical Supplies, LLC.84afe4ae-f9e8-406f-9fbe-f413975f86eb2026-08-05WarningsExact identifier
application number: M016
Petroleum JellyPETROLATUMWalgreens1bb250ee-c4b7-4e9f-9d13-46ef9df4a9f52026-08-04WarningsExact identifier
application number: M016
Nail Treatment Repairing LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.57b8b3e5-88be-3a91-e063-6294a90a05be2026-08-03WarningsExact identifier
application number: M016
PROCUREZINC OXIDETWIN MED, LLCe68ae97e-668e-31c2-e053-2995a90ab4d32026-08-03WarningsExact identifier
application number: M016
PROCURE VITAMIN A AND D Skin ProtectantPETROLATUMTWIN MED, LLCbbbca68e-1b65-49b1-a5fa-ed4da55d05e32026-08-03WarningsExact identifier
application number: M016
procurePETROLATUMTWIN MED, LLC32520d8f-91ee-47a1-9129-bf0746791f4b2026-08-03WarningsExact identifier
application number: M016
ProCure HydroShieldPETROLATUM 44.28%Twin Med LLC3ab7bfb2-bbcf-0822-e063-6294a90af0842026-08-03WarningsExact identifier
application number: M016
456 Acne Relief CreamNIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOTGuangzhou Senmai Biotechnology Co.,Ltd.5830fd36-0613-1980-e063-6294a90adfb72026-08-03WarningsExact identifier
application number: M016
Crogooe Skin Relief CreamCOLLOIDAL OATMEALGuangdong Outeli Biotechnology Co., Ltd.57f9b3e8-25d3-2b20-e063-6394a90aaea52026-08-01WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALJCS Global Distribution, Inc.57c3556a-aad3-3e65-e063-6394a90ab6892026-07-29WarningsExact identifier
application number: M016
DERMFREE INSECT BITE RELIEFSODIUM BICARBONATE 5% INSECT BITE RELIEFWenzhou Yuyuan Pharmaceutical Co., Ltd.5794886c-0d74-9f35-e063-6394a90a27d82026-07-27WarningsExact identifier
application number: M016
OKeeffes Lip Repair SEAL and HEALPETROLATUMThe Gorilla Glue Company/O'Keeffe's Company55f66f54-da39-76c7-e063-6394a90aeda92026-07-27WarningsExact identifier
application number: M016
ATTITUDE Baby Leaves Diaper cream - UnscentedZINC OXIDE9055-7588 Quebec Inc. (Attitude)579aa481-f8ec-b263-e063-6394a90a77542026-07-27WarningsExact identifier
application number: M016
Boo Boo Magic Diaper Rash CreamyZINC OXIDEAlboo Brands LLC5114aff8-adde-e610-e063-6294a90a77ea2026-07-27WarningsExact identifier
application number: M016
PrevaDRM Vitamin RepairSKIN PROTECTANTSion Brands LLC579e4639-a742-1901-e063-6294a90a2d452026-07-27WarningsExact identifier
application number: M016
Hello Bello Diaper Rash CreamZINC OXIDETopiderm, Inc.e158ba31-e159-4624-a490-fe70baaf4a392026-07-24WarningsExact identifier
application number: M016
Gethorey Vein Target Microneedle PatchALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57593145-a874-15d9-e063-6294a90a77d92026-07-24WarningsExact 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