Zinc Oxide

Product NDC
11822-0534
11-digit product format
118220534
Labeler code
11822
Product ID
11822-0534_499ed471-d111-2f4b-e063-6294a90ab925
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Rite Aid Corporation
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-24
Substance
ZINC OXIDE
Active strength
400 mg/g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 OXIDE400 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
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
3af9f0e5-0d79-4178-b29e-3b60735bf4ceAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0534-1Zinc Oxide113 g in 1 TUBEOINTMENT1135
11822-0534-1Zinc Oxide1 in 1 PACKAGEOINTMENT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0534ZINC OXIDE OINTMENT [RITE AID]3Current NDC, Legacy NDC, 2 package rows20240809_3af9f0e5-0d79-4178-b29e-3b60735bf4ce.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 27 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eczema Relief Cream Body WashOATMEALBeiersdorf Incf12644e5-0ff0-de0e-e053-2995a90a09952025-12-31WarningsExact identifier
application number: M016
XIMONTH Honey Eye DropsGLYCERINShantou Ximonth Biotechnology Co., Ltd.4727f304-0bc7-2fee-e063-6394a90a01782025-12-30WarningsExact identifier
application number: M016
Kinfield Relief Balm Anti-Itch RemedyKINFIELD RELIEF BALM ANTI-ITCH REMEDYKinfield, Inc.bf394192-c789-faff-e053-2995a90a52bc2025-12-30WarningsExact identifier
application number: M016
911ALLANTOINSkinfix, Inc.f28c251e-a91b-4ed4-8224-b47c345f982f2025-12-29WarningsExact identifier
application number: M016
EXTRA STRENGTH BODYCOLLOIDAL OATMEALSkinfix, Inc.32ba5f29-c037-44dd-b5b1-59001ac507532025-12-29WarningsExact identifier
application number: M016
VITACILINA Bebe Diaper RashALLANTOIN, ZINC OXIDECompania Internacional de Comercio, S.A.P.I de C.V.39726b59-bd85-4541-80e5-4f2919842dca2025-12-29WarningsExact identifier
application number: M016
Creamy Diaper RashZINC OXIDEDavion, Inc0fdfe7d3-e4cd-6bea-e063-6394a90a37f62025-12-29WarningsExact identifier
application number: M016
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
application number: M016
WinCo FoodsPetroleum JellyWHITE PETROLATUMWinCo Foods, LLCf5dcf0b2-4f9f-023a-e053-2995a90a183a2025-12-28WarningsExact identifier
application number: M016
WinCo FoodsPetroleum JellyWHITE PETROLATUMWinCo Foods, LLCf5dca60a-e9bc-4161-e053-2995a90a2bcb2025-12-28WarningsExact identifier
application number: M016
Hydrating HealingHYDRATING HEALING OINTMENTNeilmed Pharmaceuticals Inc.,47106abb-4c39-07d9-e063-6394a90a4fae2025-12-28WarningsExact identifier
application number: M016
TCX SkincareCOLLOIDAL OATMEALTheraceutix, LLCc3be950b-28cf-47c2-9570-ebd46e43b1ba2025-12-24WarningsExact identifier
application number: M016
Nizoral Eczema Relief CreamCOLLOIDAL OATMEALKramer Laboratoriesda3a39d7-197f-4451-9d24-f92adbe0fc192025-12-23WarningsExact identifier
application number: M016
Healing Head to ToeALLANTOINThe Honest Company, Incdc02033f-8116-1710-e053-2995a90aff692025-12-23WarningsExact identifier
application number: M016
Honest Eczema CreamCOLLOIDAL OATMEALThe Honest Company, Inc.6f111094-425b-4a8c-b71a-5ff65f4a80002025-12-23WarningsExact identifier
application number: M016
BABY ANTI MONKEY BUTT DIAPER RASHZINC OXIDE, CALAMINEClarion Brands, LLCe4424d74-f89c-5943-42e8-bf3a38e686192025-12-23WarningsExact identifier
application number: M016
Dissolvable Microneedle Eye PatchesALLANTOINAdvaccine Biopharmaceuticals Suzhou Co., Ltd4684fa4e-5c5e-045d-e063-6394a90af0692025-12-22WarningsExact identifier
application number: M016
Good Neighbor Petroleum JellyWHITE PETROLATUMAmerisourceBergene5fb80a0-cc8c-e9e7-e053-2a95a90a455d2025-12-22WarningsExact identifier
application number: M016
TENA PROSKIN BARRIERDIMETHICONEEssity HMS North America Inc118bf2df-ee7b-454f-9c0b-2697dc8262682025-12-21WarningsExact identifier
application number: M016
Geri Care Medicated PadsWITCH HAZELGeri-Care Pharmaceuticals, Corp2d020e79-2bcf-ba8f-e063-6394a90a6fda2025-12-19WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
244638zinc oxide 40 % Topical OintmentPSN3af9f0e5-0d79-4178-b29e-3b60735bf4ce5
244638zinc oxide 0.4 MG/MG Topical OintmentSCD3af9f0e5-0d79-4178-b29e-3b60735bf4ce5
244638zinc oxide 40 % Topical OintmentSY3af9f0e5-0d79-4178-b29e-3b60735bf4ce5
244638ZNO 0.4 MG/MG Topical OintmentSY3af9f0e5-0d79-4178-b29e-3b60735bf4ce5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0534-1118220534011 TUBE in 1 PACKAGE (11822-0534-1) / 113 g in 1 TUBE1 tube2022-08-240000-00-00NoNoCurrent