Home NDC 11701-082 Baza Protect
Product NDC 11701-082
11-digit product format 117010082
Labeler code 11701
Product ID 11701-082_7819db44-465c-4283-81fd-5f1bfd6ee11f
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide and Dimethicone
Dosage form CREAM
Route TOPICAL
Labeler Coloplast Corp
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-04-06
Substance ZINC OXIDE; DIMETHICONE, UNSPECIFIED
Active strength 120; 10 mg/g; mg/g
Pharmacologic classes Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 20 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Baza Protect
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 120 mg/g DIMETHICONE, UNSPECIFIED 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 92RU3N3Y1O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 637565 Internal RxNorm lookup 1053158 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11701-082-03 Baza Protect 57 g in 1 TUBE CREAM 57 3 11701-082-22 Baza Protect 4 g in 1 PACKET CREAM 4 3 11701-082-24 Baza Protect 142 g in 1 TUBE CREAM 142 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11701-082 BAZA PROTECT (ZINC OXIDE AND DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC] 2 Current NDC, Legacy NDC, 3 package rows 20241004_256dfcfc-a91c-49b0-9439-452586a0880e.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 55 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 11701-082-03 11701008203 57 g in 1 TUBE (11701-082-03) 57 g 2020-04-06 0000-00-00 No No Current 11701-082-22 11701008222 4 g in 1 PACKET (11701-082-22) 4 g 2020-04-06 0000-00-00 No No Current 11701-082-24 11701008224 142 g in 1 TUBE (11701-082-24) 142 g 2020-04-06 0000-00-00 No No Current