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

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 Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z
Rxcui1039181, 1039185

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

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