FDA.reportPublic FDA data

Manzatin-E Diaper Rash Skin Protectant

Product NDC
55715-002
11-digit product format
557150002
Labeler code
55715
Product ID
55715-002_0b7644d3-9fd8-b562-e063-6294a90ae44b
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
2009-10-01
Substance
ZINC OXIDE
Active strength
18 g/100g
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-E Diaper Rash Skin Protectant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE18 g/100g

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1039181Internal RxNorm lookup
1039185Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cafd084f-8493-4d6e-b256-2d4b4282f866Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55715-002-02Manzatin-E Diaper Rash Skin Protectant90 g in 1 TUBEOINTMENT906
55715-002-06Manzatin-E Diaper Rash Skin Protectant180 g in 1 TUBEOINTMENT1806
55715-002-06Manzatin-E Diaper Rash Skin Protectant1 in 1 BOXOINTMENT16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZMANZATIN-E DIAPER RASH SKIN PROTECTANT (ZINC OXIDE) OINTMENT [LABORATORIOS ZEPOL S.A.]4
ZINC CATIONACTIVE MOIETY13S1S8SF37MANZATIN-E DIAPER RASH SKIN PROTECTANT (ZINC OXIDE) OINTMENT [LABORATORIOS ZEPOL S.A.]4
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XMANZATIN-E DIAPER RASH SKIN PROTECTANT (ZINC OXIDE) OINTMENT [LABORATORIOS ZEPOL S.A.]4
COD LIVER OILINACTIVE INGREDIENTBBL281NWFGMANZATIN-E DIAPER RASH SKIN PROTECTANT (ZINC OXIDE) OINTMENT [LABORATORIOS ZEPOL S.A.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMANZATIN-E DIAPER RASH SKIN PROTECTANT (ZINC OXIDE) OINTMENT [LABORATORIOS ZEPOL S.A.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55715-002MANZATIN-E DIAPER RASH SKIN PROTECTANT (ZINC OXIDE) OINTMENT [LABORATORIOS ZEPOL S.A.]6Current NDC, Legacy NDC, 3 package rows20231202_cafd084f-8493-4d6e-b256-2d4b4282f866.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 33 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetaphil Soothing Gel CreamALLANTOINGalderma Laboratories, L.P.bab404f0-2f7a-4bac-b053-cbdc81c029b52025-11-24WarningsExact identifier
application number: M016
health beyond VITAMINS ADPETROLATUMNantong Health & Beyond Hygienic Products Inc.de87da51-cf92-402c-b60f-5f28d17241242025-11-23WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUMMedline Industries, LP00766a7b-797e-dd15-e063-6394a90af9ac2025-11-20WarningsExact identifier
application number: M016
Itch Eraser SensitiveSODIUM BICARBONATETender Corporation d/b/a Adventure Ready Brands2250525a-45c2-42ea-e063-6394a90ac0012025-11-18WarningsExact identifier
application number: M016
Moisture Barrier CreamPETROLATUM, ZINC OXIDEDerma Sciences Canada Inc.43e01e22-7872-8e24-e063-6394a90a17ef2025-11-18WarningsExact identifier
application number: M016
terrasil Bed Sore and Pressure Sore ReliefALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionsd0e4a492-f833-4e92-bd4a-b0a07ce9a69e2025-11-18WarningsExact identifier
application number: M016
terrasil Foot Ulcer and Sore ReliefALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions2776080b-3ddb-ad6c-e063-6394a90a93e02025-11-18WarningsExact identifier
application number: M016
After Bite KidsSODIUM BICARBONATETender Corporation d/b/a Adventure Ready Brands226c1420-d771-204f-e063-6294a90af9f62025-11-18WarningsExact identifier
application number: M016
Petroleum with CocoaWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)280d4bdb-30d3-44f2-9159-3aa9a1de9a5f2025-11-17WarningsExact identifier
application number: M016
After Bite X TechSODIUM BICARBONATEAdventure Ready Brandse9e49ab4-3e1f-9fd4-e053-2a95a90a775a2025-11-17WarningsExact identifier
application number: M016
Diaper Rash skin protectantLANOLIN AND PETROLATUMUniversal Distribution Centre LLC29b5475d-6085-cfe6-e063-6294a90a7e742025-11-17WarningsExact identifier
application number: M016
DERMOGENZINC OXIDEKRAMER NOVIS38e02d1c-c143-4da6-ad32-a3ce2861aac52025-11-14WarningsExact identifier
application number: M016
Welmedix HomeCare PRO Rapid Relief Rash CreamPETROLATUM, ZINC OXIDEWelmedix LLC4382a6b4-0b1f-0822-e063-6394a90adffc2025-11-14WarningsExact identifier
application number: M016
Petroleum with CocoaWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)086b6563-cb73-4874-aa42-028f5e81b60d2025-11-13WarningsExact identifier
application number: M016
Welmedix HomeCare PRO Fragile Skin ProtectantPETROLATUMWelmedix LLC43840785-3640-9813-e063-6394a90a77702025-11-13WarningsExact identifier
application number: M016
Petroleum Jelly Baby Fresh Scent 3.53ozPETROLATUMRejoice International Corp.1309926f-ecd9-635e-e063-6294a90aaab32025-11-11WarningsExact identifier
application number: M016
Petroleum Jelly Fragrance Free 3.53ozPETROLATUMRejoice International Corp.12f8d9cc-aa77-e034-e063-6394a90a94dd2025-11-11WarningsExact identifier
application number: M016
Petroleum Jelly Cocoa Butter Scent 3.53ozPETROLATUMRejoice International Corp.1309b15b-5236-6e9f-e063-6294a90afe112025-11-11WarningsExact identifier
application number: M016
ODLUMIVIE Tremella Revitalizing CleanserTREMELLA FUCIFORMIS WHOLEODLUMIVIE435e4736-bcef-c227-e063-6394a90a53d52025-11-11WarningsExact identifier
application number: M016
ODLUMIVIE Peptide CalmMistPALMITOYL TRIPEPTIDE-8ODLUMIVIE435e6717-5fbf-5cb2-e063-6294a90a40d72025-11-11WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039185Manzatin-E 18 % Topical OintmentPSNcafd084f-8493-4d6e-b256-2d4b4282f8666
1039181zinc oxide 18 % Topical OintmentPSNcafd084f-8493-4d6e-b256-2d4b4282f8666
1039185zinc oxide 0.18 MG/MG Topical Ointment [Manzatin-E]SBDcafd084f-8493-4d6e-b256-2d4b4282f8666
1039181zinc oxide 0.18 MG/MG Topical OintmentSCDcafd084f-8493-4d6e-b256-2d4b4282f8666
1039185Manzatin-E 0.18 MG/MG Topical OintmentSYcafd084f-8493-4d6e-b256-2d4b4282f8666
1039185Manzatin-E 18 % Topical OintmentSYcafd084f-8493-4d6e-b256-2d4b4282f8666
1039181zinc oxide 18 % Topical OintmentSYcafd084f-8493-4d6e-b256-2d4b4282f8666
1039181ZNO 0.18 MG/MG Topical OintmentSYcafd084f-8493-4d6e-b256-2d4b4282f8666
1039185ZNO 0.18 MG/MG Topical Ointment [Manzatin-E]SYcafd084f-8493-4d6e-b256-2d4b4282f8666

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55715-002-025571500020290 g in 1 TUBE (55715-002-02) 90 g2009-10-010000-00-00NoNoCurrent
55715-002-06557150002061 TUBE in 1 BOX (55715-002-06) / 180 g in 1 TUBE1 tube2009-10-010000-00-00NoNoCurrent