Medline

Product NDC
53329-768
11-digit product format
533290768
Labeler code
53329
Product ID
53329-768_41349255-e0cd-8d71-e063-6394a90a32ca
Type
HUMAN OTC DRUG
Nonproprietary name
zinc oxide
Dosage form
SPRAY
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-01
Substance
ZINC OXIDE
Active strength
250 mg/mL
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
Medline
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE250 mg/mL

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
865073Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dae45414-7401-9536-e053-2a95a90a0a86Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-768-55Medline59 mL in 1 BOTTLE, SPRAYSPRAY593

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-768MEDLINE (ZINC OXIDE) SPRAY [MEDLINE INDUSTRIES, LP]2Current NDC, 1 package rows20241027_dae45414-7401-9536-e053-2a95a90a0a86.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 21 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily MoisturizingDIMETHICONETopco Associates LLC47e54eee-70e0-4bfa-ae77-d61a6560a9e12026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELTopco Associates LLC471a9f8d-ba12-41d3-a510-20c1a13ff8502026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Skin ProtectantPETROLATUMWakefern Food Corp.b799229b-f7ca-494c-afde-1fd096aef66e2026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEWinCo Foods, LLC659cc8c7-6300-41c0-a684-c5fde7f2b1002026-02-12Warnings, Adverse reactionsExact identifier
application number: M016
Zinc OxideZINC OXIDEWalgreen Co.220f70e1-0802-4fe2-92d0-78dec557c9932026-02-12Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELWalgreen Co.417ae199-54bb-420f-a3cf-1c096062d78c2026-02-12Warnings, Adverse reactionsExact identifier
application number: M016
First Aid Beauty Dry Skin Rescue KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company4a93d029-d721-0bb5-e063-6294a90a17c42026-02-11WarningsExact identifier
application number: M016
Natouch Eczema WipesECZEMA WIPESNatouch LLC0a9756a4-2fa9-cd19-e063-6294a90a93ad2026-02-10WarningsExact identifier
application number: M016
EARTHS CARE Eczema CreamECZEMADLC Laboratories, Inc.17436fa0-d6c7-1052-e063-6294a90adae42026-02-09WarningsExact identifier
application number: M016
PetrolatumWHITE PETROLATUMRetail Business Services, LLCbf0c9494-0138-4346-9348-e235ca4d9e582026-02-06Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATERetail Business Services, LLCa80b8fee-2dd9-4640-a4f8-4cf940df85632026-02-06Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMRetail Business Services, LLC6e9121c8-5eb9-4d0b-86c5-b892e14bdab82026-02-06WarningsExact identifier
application number: M016
PetrolatumWHITE PETROLATUMRetail Business Services, LLCbf73c618-ed2f-4468-a51f-ff61c7b1f5062026-02-06Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONERetail Business Services, LLCc8a876e2-0a34-4c3d-a0bc-549dd3048e8a2026-02-06Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMSalado Sales Inc.f973e3a5-3b45-4842-99ce-dff676ae1f962026-02-06Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMPharmacy Value Alliance, LLC0ce03cd1-c48d-45cf-b11f-08bade55dcb62026-02-05Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONEPublix Super Markets, Inc.28ac9de4-2a63-4839-bed5-9bcc59ebeb2a2026-02-05Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELPublix Super Markets, Inc.0098c983-c518-4a14-8635-c7bdde7bff4f2026-02-05Warnings, Adverse reactionsExact identifier
application number: M016
TN Dickinsons Pain and Itch ReliefPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEDickinson Brands Inc.537c9c27-ee81-4920-8e3f-21edb844c9cf2026-02-05WarningsExact identifier
application number: M016
Aveeno Eczema Therapy Nighttime Itch Relief BalmCOLLOIDAL OATMEALKenvue Brands LLCe3350a8f-b983-7c4d-e053-2a95a90a53f52026-02-04WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865073zinc oxide 25 % Topical SprayPSNdae45414-7401-9536-e053-2a95a90a0a863
865073zinc oxide 250 MG/ML Topical SpraySCDdae45414-7401-9536-e053-2a95a90a0a863
865073zinc oxide 25 % Topical SpraySYdae45414-7401-9536-e053-2a95a90a0a863
865073ZNO 250 MG/ML Topical SpraySYdae45414-7401-9536-e053-2a95a90a0a863

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53329-768-555332907685559 mL in 1 BOTTLE, SPRAY (53329-768-55) 59 ml2023-12-01NoNoCurrent