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#

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 64 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premier Value CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEChain Drug Consortium5c89e3ac-ca4d-ec3a-e053-2a91aa0a1c0b2023-12-20WarningsExact identifier
application number: M016
Best Choice Medicated CalamineZINC ACETATE AND PRAMOXINE HYDROCHLORIDEValu Merchandisers, CO.5d6c668a-80b4-de18-e053-2991aa0a38fb2023-12-20WarningsExact identifier
application number: M016
Premiere Value CalamineCALAMINE 8% AND ZINC OXIDE 8%Chain Drug Consortium5c8bde5a-591d-085f-e053-2991aa0a56af2023-12-20WarningsExact identifier
application number: M016
Best Choice Anti-Itch ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEValu Merchandisers, CO5d6c51b8-47f8-c38b-e053-2991aa0a0f232023-12-20WarningsExact identifier
application number: M016
Health Care CalamineCALAMINE 8% AND ZINC OXIDE 8%Great Lakes Wholesale, Marketing and Sales Inc5d8f02fb-0794-8ec2-e053-2991aa0aac632023-12-20WarningsExact identifier
application number: M016
Harris Teetter CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEHarris Tetter, LLC.5c7a7418-c973-2869-e053-2991aa0ab4f52023-12-20WarningsExact identifier
application number: M016
Harris Teeter CalamineZINC OXIDEHarris Teeter, LLC.86021cc5-fea7-4363-8fb2-2b0484437fe82023-12-20WarningsExact identifier
application number: M016
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE AND ZINC ACETATECVS Pharmacyc60cfbf2-6788-43dc-b23a-e3433b7f32652023-12-20WarningsExact identifier
application number: M016
Sunmark CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLCc7467f21-56cc-43ca-abfa-e62d35c8baa62023-12-19WarningsExact identifier
application number: M016
Sunmark Witch HazelWITCH HAZELStrategic Sourcing Services LLC08c00c1a-7ec8-4624-9db0-a0e8430cd1262023-12-19WarningsExact identifier
application number: M016
Sunmark Caldyphen ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services LLC329cd4ef-b699-46ff-a5d6-907f7c327c032023-12-19WarningsExact identifier
application number: M016
DDM CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d536077-b5c6-29b8-e053-2a91aa0a9ae12023-12-19WarningsExact identifier
application number: M016
Sunmark Phenolated CalamineCALAMINE AND ZINC OXIDE AND PHENOLStrategic Sourcing Services LLC8e68efc4-4c95-41c0-9fed-32297b1b2edc2023-12-19WarningsExact identifier
application number: M016
Calm and Heal Melting BalmALLANTOINThe Honest Company, Inc.b08a1bd6-986d-9520-e053-2995a90a865e2023-12-19WarningsExact identifier
application number: M016
TopCare CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDE LOTIONTOPCO ASSOCIATES LLC8dced3ea-147b-3d46-e053-2a95a90aa1c02023-12-18WarningsExact identifier
application number: M016
TopCare CalamineCALAMINE 8% AND ZINC OXIDE 8% LOTIONTOPCO ASSOCIATES LLC8dcf134e-0427-0c43-e053-2995a90a7c262023-12-18WarningsExact identifier
application number: M016
HEB CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d576794-88d1-484a-e053-2991aa0aa4792023-12-18WarningsExact identifier
application number: M016
Publix Calamine MedicatedZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6ba4cf-f2cb-0ecb-e053-2991aa0a56732023-12-18WarningsExact identifier
application number: M016
TopCare CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONTOPCO ASSOCIATES LLC8dce8817-b905-4064-e053-2995a90a071e2023-12-18WarningsExact identifier
application number: M016
Assured CalamineCALAMINE 8% AND ZINC OXIDE 8%Greenbriar International9d378cc5-9af0-1389-e053-2995a90a0b962023-12-18WarningsExact 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