FDA.reportPublic FDA data

Manzatin Diaper Rash Skin Protectant

Product NDC
55715-005
11-digit product format
557150005
Labeler code
55715
Product ID
55715-005_0b7655c5-a49d-c9a5-e063-6394a90a177d
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Laboratorios Zepol S.A.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-01
Substance
ZINC OXIDE
Active strength
180 mg/g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Manzatin Diaper Rash Skin Protectant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE180 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
1039181Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5c1618a4-ca08-4814-a556-74e79db618b9Available 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
55715-005-01Manzatin Diaper Rash Skin Protectant90 g in 1 TUBEOINTMENT902
55715-005-02Manzatin Diaper Rash Skin Protectant130 g in 1 BOTTLEOINTMENT1302
55715-005-03Manzatin Diaper Rash Skin Protectant170 g in 1 TUBEOINTMENT1702
55715-005-04Manzatin Diaper Rash Skin Protectant180 g in 1 TUBEOINTMENT1802
55715-005-05Manzatin Diaper Rash Skin Protectant235 g in 1 BOTTLEOINTMENT2352

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55715-005MANZATIN DIAPER RASH SKIN PROTECTANT (ZINC OXIDE) OINTMENT [LABORATORIOS ZEPOL S.A.]2Current NDC, Legacy NDC, 5 package rows20231202_5c1618a4-ca08-4814-a556-74e79db618b9.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 56 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aveeno Daily MoisturizingDIMETHICONEKenvue Brands LLC70593b0c-c41b-4294-9bfa-42003ba1e3e42024-11-05WarningsExact identifier
application number: M016
Aveeno Baby Calming ComfortDIMETHICONEKenvue Brands LLC029fbae2-06ad-4fe9-b542-834686c5cb972024-11-05WarningsExact identifier
application number: M016
Aveeno Skin Relief OvernightDIMETHICONEKenvue Brands LLCe7da6c9c-d6b0-4dc5-bfa4-68345f9c2d3c2024-11-05WarningsExact identifier
application number: M016
Quality Choice Diaper RashZINC OXIDEChain Drug Marketing Association Inc.262e7eac-4b44-f224-e063-6394a90a4f592024-11-05WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDEChain Drug Marketing Association Inc.262f8cab-c7b8-b07e-e063-6294a90a12892024-11-05WarningsExact identifier
application number: M016
ECZEMAOATMEALORGANIC & SUSTAINABLE BEAUTY926706b5-0a08-4604-b5ad-3b3ddfd7f02d2024-11-05WarningsExact identifier
application number: M016
Walgreens Eczema Relief Body Skin ProtectantOATMEALWalgreen Companyb2eebc2f-addd-4822-b224-04bd5f4506532024-11-05WarningsExact identifier
application number: M016
ECZEMAOATMEALORGANIC & SUSTAINABLE BEAUTY81eb3df4-5beb-45aa-82ca-e8b4b37e45f42024-11-05Warnings, Adverse reactionsExact identifier
application number: M016
Aveeno Baby Calming ComfortDIMETHICONEKenvue Brands LLC567b1481-b783-45f9-af38-5630c9edf0442024-11-01WarningsExact identifier
application number: M016
ZO Skin Health Astringent SolutionALUMINUM ACETATEZO Skin Health, Inc.cb801d7e-52ad-6c16-e053-2a95a90a7a1f2024-10-31WarningsExact identifier
application number: M016
ZINC OXIDE PHARMAZINC OXIDEALLIED TRADE LINK LLC1b580bf6-f217-5c0f-e063-6294a90a012e2024-10-29WarningsExact identifier
application number: M016
Dove DermaSeries Eczema Relief Soothing BodyCOLLOIDAL OATMEALConopco, Inc. d/b/a/ Unilever59f737f6-dd3f-4b63-b13e-2345cb9a951a2024-10-24WarningsExact identifier
application number: M016
DoveHAND SANITIZER SHEA BUTTERConopco Inc. d/b/a/ Unilevera735d885-bacd-0f5c-e053-2a95a90ad14a2024-10-24WarningsExact identifier
application number: M016
Baby Dove8H MOISTURIZATION HAND SANITIZERConopco Inc. d/b/a/ Unileverb8dc481c-1ac3-2d63-e053-2a95a90a44f52024-10-24WarningsExact identifier
application number: M016
VaselineCLINICAL CARE HAND SANITIZER LOTIONConopco Inc. d/b/a/ Unileverba0aa323-8887-597f-e053-2995a90a20772024-10-24WarningsExact identifier
application number: M016
DoveNOURISHING HAND SANITIZER SENSITIVE SKIN 8HR MOISTURIZATIONConopco Inc. d/b/a/ Unileverd1039316-3ca8-90f8-e053-2995a90a20612024-10-24WarningsExact identifier
application number: M016
DoveHAND SANITIZER LAVENDERConopco Inc. d/b/a/ Unilevera736838b-b559-f066-e053-2995a90a90f52024-10-24WarningsExact identifier
application number: M016
Diaper Rash Cream 2.5ozZINC OXIDERejoice International Corp.130d94d8-ad98-d61f-e063-6294a90a76b02024-10-21WarningsExact identifier
application number: M016
HARMON DAILY MOISTURZIERDIMETHICONEHARMON STORES, INC.bda5dbaa-5d62-4a40-ba55-e2066e8ca1c72024-10-21WarningsExact identifier
application number: M016
DimethiconeBODY SHIELDMcKesson8febb45d-a200-702c-e053-2995a90a3e622024-10-18WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039181zinc oxide 18 % Topical OintmentPSN5c1618a4-ca08-4814-a556-74e79db618b92
1039181zinc oxide 0.18 MG/MG Topical OintmentSCD5c1618a4-ca08-4814-a556-74e79db618b92
1039181zinc oxide 18 % Topical OintmentSY5c1618a4-ca08-4814-a556-74e79db618b92
1039181ZNO 0.18 MG/MG Topical OintmentSY5c1618a4-ca08-4814-a556-74e79db618b92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55715-005-015571500050190 g in 1 TUBE (55715-005-01) 90 g2021-11-010000-00-00NoNoCurrent
55715-005-0255715000502130 g in 1 BOTTLE (55715-005-02) 130 g2021-11-010000-00-00NoNoCurrent
55715-005-0355715000503170 g in 1 TUBE (55715-005-03) 170 g2021-11-010000-00-00NoNoCurrent
55715-005-0455715000504180 g in 1 TUBE (55715-005-04) 180 g2021-11-010000-00-00NoNoCurrent
55715-005-0555715000505235 g in 1 BOTTLE (55715-005-05) 235 g2021-11-010000-00-00NoNoCurrent