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 68 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Vital LineHYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDESANUBIS COSMETICS SLebe024f7-7c45-ad60-e053-2995a90a45d62023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaPROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOLANUBIS COSMETICS SLebdddcec-f5da-51fe-e053-2995a90a61672023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaPROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATEANUBIS COSMETICS SLeb53cba1-0509-43bc-e053-2995a90a5e092023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), PETROLATUMCarma Laboratories, Inc.5378d653-702d-405c-a067-882554aaf93a2023-08-21WarningsExact identifier
application number: M016
Quality Choice Anti-itch MedicatedCALAMINE AND PRAMOXINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC5e07f26f-cfb6-57f9-e053-2991aa0a20082023-08-02WarningsExact identifier
application number: M016
Barrier BalmBARRIER BALMAutumn Harp, Inc.01df9746-991b-4363-e063-6294a90aaac62023-08-01WarningsExact identifier
application number: M016
Barrier CreamZINC OXIDEAvasol LLCbc6a2736-faa6-46d3-af9b-a70f0762e9ce2023-05-15WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Candy CaneCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companybec2f702-5ff5-ea66-e053-2a95a90ad1ec2023-01-01WarningsExact identifier
application number: M016
Badger After-BUG BalmCOLLOIDAL OATMEALW.S. Badger Company, Inc.a623da47-cef2-146f-e053-2a95a90afe3a2021-11-17WarningsExact identifier
application number: M016
Derma-e Eczema ReliefOATMEALTopiderm, Ince1797f81-af4b-49e1-9906-dbfd904a282b2020-08-19WarningsExact identifier
application number: M016
Resurfix PlusPETROLATUMTopiderm, Inc.f100f43d-6ace-4c3a-9c85-640c0ab2e3602019-11-19WarningsExact 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