Home NDC 55715-005 Manzatin Diaper Rash Skin Protectant
Product NDC 55715-005
11-digit product format 557150005
Labeler code 55715
Product ID 55715-005_0b7655c5-a49d-c9a5-e063-6394a90a177d
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 2021-11-01
Substance ZINC OXIDE
Active strength 180 mg/g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Diaper Rash Skin Protectant
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 180 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1039181 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55715-005-01 Manzatin Diaper Rash Skin Protectant 90 g in 1 TUBE OINTMENT 90 2 55715-005-02 Manzatin Diaper Rash Skin Protectant 130 g in 1 BOTTLE OINTMENT 130 2 55715-005-03 Manzatin Diaper Rash Skin Protectant 170 g in 1 TUBE OINTMENT 170 2 55715-005-04 Manzatin Diaper Rash Skin Protectant 180 g in 1 TUBE OINTMENT 180 2 55715-005-05 Manzatin Diaper Rash Skin Protectant 235 g in 1 BOTTLE OINTMENT 235 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55715-005 MANZATIN DIAPER RASH SKIN PROTECTANT (ZINC OXIDE) OINTMENT [LABORATORIOS ZEPOL S.A.] 2 Current NDC, Legacy NDC, 5 package rows 20231202_5c1618a4-ca08-4814-a556-74e79db618b9.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 39 of 68 · 1,357 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55715-005-01 55715000501 90 g in 1 TUBE (55715-005-01) 90 g 2021-11-01 0000-00-00 No No Current 55715-005-02 55715000502 130 g in 1 BOTTLE (55715-005-02) 130 g 2021-11-01 0000-00-00 No No Current 55715-005-03 55715000503 170 g in 1 TUBE (55715-005-03) 170 g 2021-11-01 0000-00-00 No No Current 55715-005-04 55715000504 180 g in 1 TUBE (55715-005-04) 180 g 2021-11-01 0000-00-00 No No Current 55715-005-05 55715000505 235 g in 1 BOTTLE (55715-005-05) 235 g 2021-11-01 0000-00-00 No No Current