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 63 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydro GelGLYCERIN 20%Trifecta Pharmaceuticals USA LLC02e8e5d0-7844-39fe-e063-6394a90a57e12024-01-19WarningsExact identifier
application number: M016
White PetrolatumWHITE PETROLATUMSled Distribution, LLCe73a4b7a-7b27-abfc-e053-2995a90a35c22024-01-15WarningsExact identifier
application number: M016
Sunmark CaldiphenCALAMINE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services4f4d4c54-64b5-4e20-bed0-c7fb470b84342024-01-12WarningsExact identifier
application number: M016
EIGHT HOUR NIGHTDIMETHICONEREVLONb3b277f9-565a-636c-e053-2995a90a94d22024-01-12WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Eczema Relief CreamyOATMEALL'Oreal USA Products Incbcf7b985-6875-4033-a412-1bb6d3afa6d82024-01-01WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists HealingPETROLATUML'Oreal USA Products Inc.1b3ad3e8-cbac-4a92-84e2-4f3ab4512d952023-12-31WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Baby HealingPETROLATUML'Oreal USA Products Inc.fe665bbc-1172-4f59-acc6-8d5c179693b62023-12-31WarningsExact identifier
application number: M016
Quality Choice Anti-Itch ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEChain Drug Market Associatione3c0c46d-3d85-411d-a543-009064cdd19e2023-12-28WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Therapeutic HandDIMETHICONEL'Oreal USA Products Inc7fe49112-4180-415c-a380-768a8d6b21852023-12-28WarningsExact identifier
application number: M016
CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEPharma Nobis, LLCe42fccc2-1b4e-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M016
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLPharma Nobis, LLCe42fbdcc-3291-7761-e053-2995a90a71722023-12-26WarningsExact identifier
application number: M016
Humco CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDEPharma Nobis, LLCe42fb807-8cb4-ed25-e053-2995a90a67802023-12-26WarningsExact identifier
application number: M016
Leader Calamine PlusZINC OXIDE LOTIONCardinal Health, 110 dba Leader81f29789-f794-1e64-e053-2a91aa0ac85e2023-12-22WarningsExact identifier
application number: M016
CVS Calamine PlusZINC OXIDECVS Pharmacyb90cd214-d44a-4458-876d-59cc0795226d2023-12-22WarningsExact identifier
application number: M016
CalamineCALAMINE 8% AND ZINC OXIDE 8%Pharma Nobis, LLCe42f0bd6-3ad3-7e07-e053-2995a90a564a2023-12-22WarningsExact identifier
application number: M016
DDM CalamineCALAMINE 8% AND ZINC OXIDE 8%Discount Drug Mart5d53685b-ca4c-35c1-e053-2a91aa0aff6e2023-12-20WarningsExact identifier
application number: M016
DDM CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d537a11-049e-0a8d-e053-2a91aa0aa0c32023-12-20WarningsExact identifier
application number: M016
Health Mart CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLC349ea07d-79bc-46f3-9d60-85b40db51bbb2023-12-20WarningsExact identifier
application number: M016
Health Mart Witch HazelWITCH HAZELStrategic Sourcing Services LLC2a1d9b27-0bd4-4475-8218-ba0f5560a9692023-12-20WarningsExact identifier
application number: M016
Quality Choice CalamineCALAMINE 8% AND ZINC OXIDE 8%Chain Drug Market Association62fe653f-e861-472b-b193-4fdd9d25de8d2023-12-20WarningsExact 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